Integrated single use test kits for drug checking

Abstract

The disclosure provides in some aspects test kits useful for testing a sample of a substance for the presence of one or more chemical compounds, for example for drug checking, such as testing a drug sample for an adulterant or a contaminant. The disclosure provides in some further aspects single use test kits for drug checking, including test kits structured as an integrated single unit, and which may comprise multiple separable pouches, including where one pouch serves as a fluid reservoir for dissolving a test sample in a solvent for testing, such as dissolving a drug sample in water. The disclosure provides in yet further aspects methods of using the disclosed test kits, such as for drug checking. The disclosed integrated single use drug test kits are portable, user-friendly, cost-effective, efficient, reliable, and accurate, and have such other advantages and improvements over prior art test kits as are illustrated herein.

Description

INTEGRATED SINGLE USE TEST KITS FOR DRUG CHECKINGINVENTOR: Mark Johan BjbrnestrandCROSS-REFERENCE

[0001] Priority is claimed under PCT Article 8(1) and Rule 4.10 to U.S. Provisional App. No. 63 / 546,919, filed November 1, 2023, and incorporated by reference for all purposes as if fully set forth herein. The benefit of priority, where it is permitted, is also claimed to U.S. Design App. No. 29 / 971,193, filed November 1, 2024, and which in any event is fully incorporated by reference herein for all purposes, including the Appendix.FIELD OF THE INVENTION

[0002] The invention is generally in the field of test kits useful for drug checking, such as testing for an adulterant or a contaminant in a drug sample, and further relates to single use test kits, such as test kits manufactured as an integrated single unit, as well as to methods of using such test kits, as for drug checking.BACKGROUND OF THE INVENTION

[0003] Drug-related deaths have reached unprecedented levels worldwide, with significant and ongoing increases around the world. Annual drug-related deaths in the U.S. increased from fewer than 20,000 in 2000 to over 100,000 today (Information from CDC, National Center for Health Statistics, WONDER database).

[0004] The drug-death crisis is largely driven by the spread of fentanyl and other synthetic opioids through the drug supply. These synthetic opioids, along with other adulterants and contaminants, can be mixed, either intentionally or unintentionally, with substances such as MDMA, cocaine, heroin, ketamine, methamphetamine, amphetamines, various unregulated drugs, and counterfeit prescription medications.

[0005] Synthetic opioids are especially associated with a high risk of overdose due to their potency. For example, the average lethal dose of fentanyl is 2 mg, an amount that can be difficult to detect, particularly in a drug sold in pill form, as is increasingly becoming problematic (see Harris E. JAMA. 2023;330(13):1217).

[0006] Other contaminants like benzodiazepines and xylazine also present serious risks to drug user safety (Zagorski et al. Harm Reduct J. 2023;20(1):141 ). Such substances can alter overdose symptoms and may not respond to traditional overdose treatments, such as naloxone, thus complicating intervention efforts.

[0007] In response to this urgent public health problem, there is consequently an increasing need for innovative means to empower individuals with the information necessary to make safer choices.

[0008] Testing unregulated drug samples, including for the presence of adulterants and contaminants, also known as drug “checking,” is a harm reduction intervention to reduce drug use-related risks by improving individuals’ access to information about drug composition. Given the escalating and potentially lethal risks of adulteration and contamination, a portable, user-friendly, efficient, reliable, and accurate test kit for drug checking is especially needed to curb the accidental consumption of drug adulterants and contaminants.

[0009] Designing drug checking test kits for the general public presents multiple challenges. This is particularly true for drug-checking test kits that can simply and cost-effectively provide reliable and accurateresults. The challenges are exacerbated by the ways and the context in which such test kits are often used.

[0010] For example, individuals testing their drugs are typically not trained in laboratory techniques. Further, drug checking is often conducted in naturalistic settings such as bars, nightclubs, raves, and outdoor festivals, where ease of use is essential. Indeed, individuals conducting drug tests may have already consumed one or more psychoactive substances that alter or impair visual, motor, and / or cognitive functions.

[0011] Drug checking is often performed using drug test strips, and numerous types of drug test strips are available, such as test strips designed to detect fentanyl in a drug sample. However, their accuracy depends on many factors, such as the drug sample size, the limit of detection (LOD) for the contaminant or adulterant, and the method used to measure the drug and dissolve it in solvent. Some common methods, such as using a water bottle cap as a test reservoir, make it difficult to achieve an ideal dilution. There is also a large variety of different test strips on the market, and the methods for their use, as well as the instructions for their use, are variable and frequently inconsistent across tests. Moreover, some methods are inaccurate and unrecommended, yet remain prevalent in drug-using communities, such as testing the residue in a drug baggie. Even recommended methods generally depend on “eyeballing.” Information provided by the U.S. national public health agency the Centers for Disease Control and Prevention (CDC), as well as by state agencies such as the New York City Department of Health and Mental Hygiene, for example, advises to test an amount of drugs that is “enough to cover Abraham Lincoln’s hair on a penny” (see, e.g., the “Fentanyl Test Strip Instructional Brochure” published by NYC Health as “How To Test Your Drugs Using Fentanyl Test Strips”). Because of these and other issues, drug test strips lead to both false negatives and false positives.

[0012] Accordingly, there remains an urgent need for drug checking means and methods that are easy to understand and use, deliver rapid, accurate, and reliable results, and are cost-effective, enabling their broad distribution and practical application. Fulfilling this need may significantly reduce the harms, including the adulteration-related deaths (lethal “overdoses”), that presently accompany the use of unregulated drugs.

[0013] Provided herein are drug test kits, such as integrated single use drug test kits, to meet this need and others, and that have such advantages and improvements over prior art drug checking means and methods as will be readily appreciated from the disclosure below.INCORPORATION BY REFERENCE

[0014] Each cited patent, publication, and non-patent literature is incorporated by reference in its entirety, as if each was incorporated by reference individually, and as if fully set forth herein. However, no such citation should be construed as an admission that a cited reference is from an area that is analogous or directly applicable to the invention, nor should any citation be construed as an admission that a document or underlying information, in any jurisdiction, is prior art or part of the common general knowledge in the art.BRIEF SUMMARY OF THE INVENTION

[0015] The following is a simplified summary of some embodiments of the invention in order to provide a basic understanding thereof. It is not an extensive overview of the invention, and is not intended to identifykey or critical elements of the invention or to delineate the full scope thereof. Its purpose is to present some embodiments of the invention in a simplified form as a prelude to the more detailed description that follows.

[0016] From the simplified summary below, and further from the detailed description that follows, one of skill will readily appreciate the varied and many advantages and improvements of the invention. Exemplary such advantages and improvements include, in embodiments, the disclosure of all-in-one “integrated” kits that can provide a streamlined and precise testing experience for any substance, all within a neatly designed and compact package, which may comprise one or more pouches, such as a pouch structured to form a reservoir. Disclosed methods of using these and other disclosed test kits, in such and other embodiments, are intuitive and minimize errors, ensuring confidence in the accuracy and reliability of results. In embodiments, disclosed test kits are designed for precision, may comprise a scoop structured to ensure a correct quantity of substance is measured, and may further comprise a water reservoir having clear measurement markings designed to prevent both over and under dilution. In embodiments, methods of using the disclosed test kits can be performed using a limited number of simple and quick steps, such as scooping, dipping, and reading results. Further advantages will be understood from the aspects and embodiments below and that follow.

[0017] In some aspects are provided integrated single use test kits for detecting a contaminant in a sample, comprising packaging material structured to form a plurality of pouches, wherein: (a) a first pouch is structured to form a reservoir for holding a volume of a solvent; (b) the first pouch contains a scoop designed to measure a quantity of the sample; (d) a second pouch contains a test strip designed to detect the contaminant; (e) the first pouch and the second pouch are separably connected; and (f) the first pouch and the second pouch are designed to remain closed until opened for use.

[0018] In embodiments, the packaging material comprises a thermoplastic polymer.

[0019] In embodiments, the first pouch is structured to form a reservoir having a capacity of between about 25 mL and about 100 mL. In embodiments, the first pouch is structured to form a reservoir having a capacity of about 74 mL. In embodiments, the first pouch comprises a transparent or translucent window. In embodiments, the transparent or translucent window comprises measurement marks. In embodiments, an interior surface of the first pouch comprises a metallic foil material.

[0020] In embodiments, the scoop has a capacity of about 0.01 mL or of about 10 mg.

[0021] In embodiments, the test strip is a lateral flow assay test strip. In embodiments, the test strip is a lateral flow immunoassay test strip. In embodiments, the test strip is designed to detect a contaminant in a drug sample. In embodiments, the test strip is designed to detect fentanyl, a benzodiazepine, or xylazine. In embodiments, the test strip is a fentanyl test strip. In embodiments, the test strip is designed to detect a non-drug compound.

[0022] In embodiments, the first pouch and the second pouch are separably connected along the length of a right side edge or a left side edge of the first pouch and the second pouch. In embodiments, the firstpouch and the second pouch are separably connected with a frangible connection. In embodiments, the frangible connection is structured to allow the pouches to be separated with minimal manual force.

[0023] In embodiments, the first pouch and the second pouch are designed to remain closed until opened by tearing along the top side edge. In embodiments, the first pouch and the second pouch comprise tear notches to enable opening by tearing along the top side edge.

[0024] In embodiments, the exterior surface of the material comprises a QR code. In embodiments, the exterior surface of the material comprises instructions for use.

[0025] In embodiments, the disclosed test kits further comprise a third pouch. In embodiments, the third pouch contains a printed guide.

[0026] In embodiments, the overall dimensions of the test kit are less than 20 cm by 20 cm. In embodiments, the overall dimensions of the test kit are about 15 cm by about 16 cm.

[0027] In embodiments, a single sheet of material is structured to form the plurality of pouches. In embodiments, the plurality of pouches is formed solely from the single sheet.

[0028] In some aspects are provided methods of manufacturing the disclosed test kits comprising: (a) folding a single sheet of material to form a bottom edge; (b) sealing the single sheet of material to form a sealed right side edge and a sealed left side edge; (c) creating at least one separable connection between the right side edge and the left side edge, wherein the separable connection is sealed along both sides of the connection thereby forming at least two pouches; (d) placing a test strip into a first pouch, and a scoop into a second pouch; (e) sealing the top side edge of each of the plurality of pouches to close the pouches; and (f) forming tear notches in each of the plurality of pouches to enable each of the plurality of pouches to be opened for use. In some aspects are provided methods of using disclosed test kits, such as according to the steps of Figure 13. Also provided are further kits and methods of manufacture and use, as enabled herein.

[0029] The foregoing has outlined broadly and in summary certain pertinent features of the disclosure so that the detailed description that follows may be better understood, and so the present contribution to the art can be more fully appreciated. This summary is a brief and general synopsis of only some of the disclosed aspects and embodiments, is provided solely for the benefit and convenience of the reader, and is not intended to limit in any manner the scope, or range of equivalents, to which the claims are entitled. Additional aspects and embodiments are described below. It will be appreciated by those in the art that all disclosed kits and methods are only exemplary, and will readily serve as a basis to modify or design other kits and methods for carrying out the same purposes, which are also within the scope of the disclosure.

[0030] The headings in this document are provided only to expedite its review by a reader. They should not be construed as limiting the invention or any of its aspects, embodiments, or applications in any manner.BRIEF DESCRIPTION OF THE FIGURES

[0031] Some exemplary aspects and embodiments of the disclosure are illustrated in the Figures, which are not intended to limit the scope of the invention, but only to provide certain additional details, and in which:

[0032] FIG. 1 illustrates a front view of an exemplary integrated single use test kit according to embodiments, where the pouches are not separated, and neither pouch is opened.

[0033] FIG. 2 illustrates a back view of an exemplary integrated single use test kit according to embodiments, where the pouches are not separated, and neither pouch is opened.

[0034] FIG. 3 illustrates a front view of an exemplary integrated single use test kit according to embodiments, where the pouches are separated, and neither pouch is opened.

[0035] FIG. 4 illustrates a back view of an exemplary integrated single use test kit according to embodiments, where the pouches are separated, and neither pouch is opened.

[0036] FIG. 5 illustrates a front view of an exemplary integrated single use test kit according to embodiments, where the pouches are separated, and both pouches are torn open.

[0037] FIG. 6 illustrates a back view of an exemplary integrated single use test kit according to embodiments, where the pouches are separated, and both pouches are torn open.

[0038] FIG. 7A illustrates a front view of a torn open reservoir pouch of an exemplary test kit.

[0039] FIGS. 7B and 7C illustrate a back view of a torn open reservoir pouch of an exemplary test kit, each containing a different liquid volume, the volume represented by the scalloped line showing the height of the liquid, such as where the volume is concomitant with an amount of drug sample being tested.

[0040] FIG. 8A illustrates a side view of a reservoir pouch of an exemplary test kit, the pouch torn open and partially filled with liquid, the height of the liquid represented by the scalloped line.

[0041] FIG. 8B illustrates a bottom view of an empty reservoir pouch of an exemplary test kit.

[0042] FIG. 8C illustrates a bottom view of a torn open reservoir pouch of an exemplary test kit, such as held for filling with liquid, or as partially filled or filled with liquid.

[0043] FIG. 8D illustrates a front perspective view from the side of a reservoir pouch of an exemplary test kit, the pouch torn open and partially filled with liquid, the liquid represented by the wavy line.

[0044] FIG. 9 illustrates a front view of an exemplary integrated single use test kit, where the pouches are separated, and both pouches are torn open. Also illustrated, as in some embodiments, is a test strip 903, a desiccant bag 904, and a scoop 905. In embodiments, the test strip and the desiccant bag are packaged in pouch 901, and the scoop is packaged in pouch 902, which is also structured to form a reservoir.

[0045] FIG. 10 illustrates a front view of an exemplary fentanyl test strip, according to embodiments.

[0046] FIG. 11 illustrates a perspective view of an exemplary scoop, according to embodiments.

[0047] FIG. 12 illustrates a perspective view of an exemplary fentanyl test strip 1201 (“FYL”), benzodiazepine test strip 1202 (“BZO”), and xylazine test strip 1203 (“XYL”), according to embodiments.

[0048] FIG. 13 is a flowchart showing an exemplary method of detecting a contaminant in a drug sample utilizing a disclosed test kit, according to embodiments.

[0049] FIGS. 14A and 14B are representative screenshots of a smartphone app for drug checking, such as in methods of using a disclosed integrated single use test kit, according to embodiments.

[0050] FIG. 15 illustrates a front view of an integrated single use test kit, where the package comprises three pouches, according to further embodiments, showing the pouches not separated and not opened.

[0051] FIG. 16 illustrates a back view of the single use test kit of the embodiments of FIG. 15, where the package comprises three pouches, the third pouch holding a paper guide (“Guide Inside”).DETAILED DESCRIPTION OF THE INVENTION

[0052] While various exemplary aspects and embodiments are summarized above, the following description illustrates several exemplary embodiments in further detail to enable one having ordinary skill in the art to which the invention pertains (also as shorthand herein, “one” or “those” “of skill” or “in the art”) to make and use the full scope of the invention as claimed. It will be understood that many modifications, substitutions, changes, and variations in the described aspects, embodiments, applications, examples, and details of the disclosed invention can be made by those in the art without departing from the spirit of the invention, or the scope of the invention as claimed, and the general principles described may be applied to a wide range of aspects and embodiments. The invention therefore should not be limited to the aspects and embodiments presented, but should be accorded the widest scope consistent with the principles and features disclosed. The description will make such principles and features apparent to those of skill, so the expressly described as well as further embodiments will be both readily cognizable and readily creatable without undue experimentation, solely using the teachings of this disclosure together with the general knowledge in the art.A. General Definitions and Terms

[0053] The singular forms “a,” “an,” and “the” include plural referents unless context clearly indicates otherwise. Thus, “a kit” may include reference to not only one but also to two or more kits. While the term “one or more” also may be used, its absence (or its replacement by the singular “a” or “an”) does not signify the singular only; rather, the term “one or more” simply emphasizes the possibility of a plurality in particular embodiments. “Or” means, and is interchangeable with, “and / or” unless context clearly indicates otherwise.

[0054] The terms “comprising,” “including,” “such as,” and “having” are inclusive and not exclusive (i.e., they do not limit lists to the recited elements), and all are interchangeable with the phrases “including but not limited to” and “including without limitation.”

[0055] The term “where,” depending on context, may be used as an equivalent to the term “wherein.”

[0056] The term “exemplary,” and other exemplary language (e.g., “such as”) means the same as “an example,” and both are the same as the phrase “one of a plurality of non-limiting examples,” and mean that other such examples may be known to those of skill, in view of the disclosure and the general knowledge in the art. An “exemplary” or “example” feature or embodiment means a representative example, but does not imply that the example is preferred or is from a group of preferred examples, unless expressly stated or context clearly indicates otherwise. Exemplary language is used merely to illustrate the invention and not to limit the scope of the invention or its applications. No language in the specification, exemplary or otherwise, should be construed as indicating that any non-claimed element is essential to the practice of the invention.

[0057] In embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Numerical ranges and parameters in some embodiments are approximations, but are reported as precisely as practicable. Numerical values may contain errors necessarily resulting from the standard deviation in their respective testing measurements.

[0058] Unless otherwise stated, all measurements, values, ratings, positions, dimensions, magnitudes, sizes, locations, orientations, configurations, and other specifications that are set forth (either expressly or impliedly) in this specification, including in the Figures and in the claims, are approximate, and not exact. They are intended to have a reasonable range that is consistent with the functions to which they relate and with what is customary in the art to which they pertain. Moreover, the recitation of ranges of values is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Each individual value within a range is incorporated herein as if it were individually recited herein.

[0059] Unless otherwise stated, all numbers and terms expressing quantities should be understood as being modified in some instances by the term “about,” even where not so stated explicitly. In alternative embodiments, such numbers and terms should be understood as not being modified by the term “about.” In embodiments, such numbers and terms are approximations that vary depending on the embodiment.

[0060] In embodiments, “about” may refer to plus or minus five percent (±5%) of the recited unit of measure. In other embodiments, “about” may refer to plus or minus ten percent (±10%) of the recited unit of measure. The term “substantially,” where it is used to modify a feature or limitation, should be read in the context of the disclosure and in light of the knowledge in the art to provide the appropriate certainty, such as by using an art-recognized standard for measuring “substantially” as a term of degree, or by otherwise ascertaining the scope as would one of skill in the art. Where no such certainty can be established from the context, the term also may be understood as meaning “about,” e.g., within ±5%, or within ±10%.

[0061] Where “about” is used to modify one number in a series or range, it modifies all numbers in the series or range, including, for a range, both the upper and lower bounds of the range. Thus, the term “about 1, 2, or 3” means “about 1 , about 2, or about 3” and the term “about 1 to 10” means “about 1 to about 10.”

[0062] The term “in embodiments” is equivalent to, and is simply shorthand for, the term “in some embodiments.” In general, the word “some” should be likewise implied where it is similarly absent, for example “according to embodiments” is equivalent to “according to some embodiments.” “Embodiments,” by context, may refer to all of, any one or more of, or one of the disclosed embodiments and their equivalents.

[0063] A “disclosed kit” or a “disclosed method” refers to any kit or method of the invention, such as described herein or claimed, and further including such kits and methods as will be understood to be equivalents by one of skill in view of this disclosure and the general knowledge of the art.

[0064] Where context does not prohibit it, “a kit” also may be used to mean, and as shorthand for, the term “a kit, including one or more aspects or limitations of the kit.” Similarly, “a method” also may be used to mean, and as shorthand for, the term “a method, including one or more steps or limitations of the method.”

[0065] The steps (including sub-steps) of any method may be performed in a different order, and unless an order provides a technical effect, a different order is an equivalent and is within the scope of the invention.

[0066] Generally, the nomenclature used and description herein will be such as known in fields relating to one or more aspects of the invention, and that will be well known and familiar to those in such fields.

[0067] Unless described otherwise, disclosed techniques and procedures are those that are standard and known in the art, and are those performed according to conventional methods in the art. If no techniques or procedures are expressly disclosed, one or more standard techniques or procedures will be performed.

[0068] Unless defined otherwise, all technical terms have the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention.

[0069] Where a specific term is used for a feature, embodiment, aspect, or the like, including a term expressly defined herein for such purposes, and the term does not have an ordinary and customary meaning in the art, its use may reflect a preference and not a limitation, unless the term provides necessary clarity or contributes to a required technical effect. Except in such cases, or if context demands otherwise, the use of an alternative term should be considered equivalent and within the scope of the disclosure, as specific terms may represent merely one means of identification and connotation where there are equivalent alternative(s).

[0070] Further definitions to assist a reader in understanding the various aspects and embodiments of the disclosed kits and methods are below and throughout; however, such definitions are not intended to limit the scope of the invention, which is properly interpreted and understood by reference to the full specification (and any plain meaning known to one of skill), in view of the language used in the claims. The terminology used herein is solely for the purpose of describing particular embodiments, and is not intended to be limiting.B. Drugs and Drug Contaminants (including Drug Adulterants)

[0071] “Drug” refers generally to a chemical compound which produces a biological effect in a living organism when administered, such as produces a psychological and / or physiological effect when ingested, inhaled, or injected by a human individual. Drugs may be regulated or unregulated, such as by state or federal regulatory systems. Regulated drugs generally have standardized doses and known quantities of active agents, such as prescription drug products regulated by the U.S. Food and Drug Administration (FDA). Unregulated drugs include those manufactured and distributed outside of government regulatory systems, generally without standardized manufacturing, packaging, labeling, or marking requirements. Unregulated drugs generally have unknown composition and concentration (dose) of the active agent. Unregulated drugs include MDMA, cocaine, heroin, ketamine, methamphetamine, amphetamines, and counterfeit prescription medications. As used herein, “drug” may refer to a specific chemical compound that an individual intends to consume (e.g., MDMA), as well as a drug substance that the individual tests with a disclosed test kit to determine if the drug is contaminated (e.g., a grayish-white crystalline powder believed to be MDMA). “Drug” thus also may mean a “drug substance” (e.g., “testing a drug”) unless context clearly indicates otherwise.

[0072] “Drug checking” refers to testing a drug sample for the presence of a chemical compound, suchas contaminant. Drug checking can involve advanced equipment (e.g., FTIR, GC-MS, IMS), or be performed with simple tools such as paper-based test strips. Drug checking is often done by individuals to test a drug substance they intend to take, as a harm reduction practice. It is different than “drug testing,” the testing of a biological sample (e.g., hair, blood, urine) from an individual for the presence of (usually illegal or illicit) drugs, such as to determine if the individual has used such drugs, and any terms herein with the words “drug” and “test” or “testing” (and other conjugations) refer to “drug checking,” unless context clearly indicates otherwise.

[0073] “Drug substance” means any substance that may be or that may contain a “drug,” that may be intended for consumption as a drug, or that in particular may be tested using a disclosed test kit. The term is not limited to an active agent or an active pharmaceutical ingredient, such as the term is used by the FDA, but broadly includes any drug substance, drug product, drug formulation, drug composition, and the like.

[0074] “Drug sample” refers to any drug substance tested, intended to be tested by, or capable of being tested by, a disclosed test kit, such as to detect the presence of a contaminant in the drug sample.

[0075] “Drug contaminant” or simply “contaminant” refers to any chemical compound that is detected or capable of being detected in a drug sample, but that is by definition not the intended drug (i.e. , the drug that a user intends to consume). For drugs that are chemically synthesized, contaminants may include reagents or solvents that were used in the synthesis, and which remain in the drug substance as impurities. For drugs derived from natural sources (e.g., by extraction of a plant or fungus), contaminants may include solvents or additives used in the extraction process as well as other extracted compounds besides the intended drug. Contaminants also may be unintentionally incorporated into a drug substance during weighing or packaging, as has been reported for example when the same equipment is used for both fentanyl and cocaine.

[0076] “Drug adulterant” or simply “adulterant” refers to a chemical compound that is intentionally added to a drug substance. An adulterant may be a pharmacologically active agent, and may itself be a drug, but is by definition not the intended drug. An adulterant may be added to alter (e.g., to complement or to enhance) the effects of the intended drug, or may be added to mimic the effects of the intended drug (e.g., cathinones or “bath salts” in a drug substance sold as “MDMA”), whether to increase the perceived potency of a lower concentration of the intended drug, or used in place of the intended drug. An “adulterant” (or “contaminant”) accordingly may be the only drug present in a drug sample (i.e., there may be no intended drug present).

[0077] The intention of a drug manufacturer or drug provider (e.g., drug “dealer”) is generally unknown to those testing a drug made or provided by such individuals, and thus it is also generally unknown whether a given chemical compound, that is not the intended drug, is present intentionally or unintentionally therein. Hence, while the term “contaminant” technically denotes a chemical compound that is unintentionally added to a drug substance, and the term “adulterant” technically denotes a chemical compound that is intentionally added to a drug substance, as used herein a “contaminant” also includes an “adulterant,” and the term “contaminant” is generally used as the encompassing term. Herein, a “contaminant” thus refers to any chemical compound intentionally or unintentionally present in a drug sample, other than the intended drug.

[0078] Exemplary contaminants include fentanyl, xylazine, benzodiazepines, and other substances as provided below. Others will be readily known in the art, and include those testable using a disclosed test kit.

[0079] It will be readily appreciated that the disclosed test kits can be used to detect the presence of contaminants such as fentanyl in samples other than drug samples, and in contexts besides drug checking.

[0080] It also will be readily appreciated that the disclosed test kits can be modified according to the teachings herein and the practice of ordinary skill, and without undue experimentation, to detect numerous other classes and types of substances besides contaminants commonly found in drug samples. Other non-limiting examples include non-drug substances and other chemical compounds such as environmental contaminants, industrial chemicals, toxic or harmful substances, and other specific substances of interest.

[0081] Accordingly, although “contaminant” generally refers herein to certain exemplary contaminants commonly found in drug samples, and disclosed test kits and methods of their use are generally described herein as being for testing for such contaminants, equivalent and additional embodiments, for testing in other contexts and / or for other compounds, will be understood from the disclosure and should be within its scope, and in other aspects are disclosed test kits for detecting other chemical compounds in other test samples.

[0082] In such other embodiments, a non-drug compound also may be referred to as a contaminant, and exemplary “contaminants” in such embodiments include, depending on context, a biological contaminant (e.g., bacterial toxins, viral antigens, mycotoxins), an environmental contaminant (e.g., pesticides, herbicides, heavy metals), a soil contaminant (e.g., fertilizer residues, hydrocarbons, pathogenic bacteria), a water contaminant (e.g., chlorine, nitrates, lead), an industrial contaminant (e.g., pollutants, chemical residues, solvents), a food contaminant (e.g., allergens, chemical additives), and an air contaminant, for example if collected by a filter and dissolved in a liquid for testing (e.g., particulate matter, volatile organic compounds).C. Test Kits

[0083] In some aspects are disclosed test kits for detecting a contaminant in a test sample, such as a drug contaminant in a drug sample.

[0084] In embodiments, a test kit comprises a test strip and a pouch structured to form or structured to form a reservoir, for example as components of the test kit. In embodiments, a test kit comprises a test strip, a scoop, and a pouch structured to form a reservoir, for example as components of the test kit.

[0085] In embodiments, the test kit is a single unit test kit, i.e., a test kit designed as a single unit, and which additionally may be manufactured as a single unit, packaged as a single unit, distributed as a single unit, sold as a single unit, and / or otherwise integrated as a single unit, for example comprising multiple components that are packaged together or otherwise integrated together.

[0086] In embodiments, an “integrated” or “single unit” test kit refers to a disclosed test kit comprising, as or within a single physical unit (e.g., a package), the components for drug checking according to a disclosed method. In embodiments, an integrated or single unit test kit comprises the components for drug checking according to a disclosed method, such as for use together with a drug sample to be tested. Inembodiments, an integrated or single unit test kit comprises the components for drug checking according to a disclosed method, such as for use together with a drug sample to be tested and a solvent for dissolving the drug sample. In embodiments, an integrated or single unit test kit comprises the components for drug checking according to a disclosed method, such as for use together with a drug sample to be tested, a solvent for dissolving the drug sample, and a scoop, where the test kit does not comprise the scoop.

[0087] Exemplary test kits and exemplary components and aspects thereof, according to embodiments, are illustrated in FIGS. 1-16. Further description of the Figures, individually and in combination, is throughout.

[0088] In embodiments, an integrated single unit test kit may be referred to equivalently and interchangeably as an “integrated” test kit, a “single unit” test kit, and for shorthand, a “package.”

[0089] In embodiments, a package comprises a plurality of subunits, for example separably connected subunits, such as a plurality of “pouches,” for example separably connected pouches. In embodiments, a package comprises two pouches, such as two separably connected pouches. FIGS. 3 and 5 depicts an exemplary package 100 comprising two separably connected pouches 106 and 107. In embodiments, a package comprises three pouches, such as three separably connected pouches. FIG. 15 depicts an exemplary package comprising three separably connected pouches 1501, 1502, and 1503. A package also may comprise further subunits, including pouches, which also may be separably connected.

[0090] A package may comprise components. In embodiments, a package comprises a test strip, as shown in FIG. 10. In embodiments, a package comprises a scoop, as shown in FIG. 11. A package may comprise two or more components. A package may comprise two components. In embodiments, a package comprises a test strip and a reservoir pouch. In embodiments, a package comprises a test strip and a scoop. In embodiments, a package comprises a reservoir pouch and a scoop. A package may comprise three or more components. A package may comprise three components. In embodiments, a package comprises a test strip, a reservoir pouch, and a scoop.

[0091] In embodiments, a package comprises a test strip, a reservoir pouch, and a scoop, packaged together as an integrated single use test kit. In embodiments, a package comprises two pouches, and comprises a test strip, a reservoir pouch, and a scoop, packaged together as an integrated single use test kit. In embodiments, a package comprises two separably connected pouches, and comprises a test strip, a reservoir pouch, and a scoop, packaged together as an integrated single use test kit. In embodiments, a package comprises two separably connected pouches, and comprises a test strip in a first pouch, and a scoop in a second pouch, the second pouch structured to form a reservoir, packaged together as an integrated single use test kit. Exemplary such packages are disclosed in the Figures.

[0092] In embodiments, a package comprises a pouch, wherein the pouch contains a test strip. In embodiments, a package comprises a pouch, wherein the pouch contains a scoop. In embodiments, a package comprises a pouch, wherein the pouch contains a test strip and a scoop. In embodiments, a package comprises a pouch, wherein the pouch is a reservoir pouch. Where reference is to a pouch that “is areservoir pouch,” the pouch may be understood as being structured to form a reservoir, or as functioning as a reservoir. In embodiments, a package comprises a pouch, wherein the pouch is a reservoir pouch, and the reservoir pouch contains a test strip. In embodiments, a package comprises a pouch, wherein the pouch is a reservoir pouch, and the reservoir pouch contains a scoop. In embodiments, a package comprises a pouch, wherein the pouch is a reservoir pouch, and the reservoir pouch contains a test strip and a scoop.

[0093] In embodiments, a package comprises two pouches, wherein one pouch contains a test strip. In embodiments, a package comprises two pouches, wherein one pouch contains a scoop. In embodiments, a package comprises two pouches, wherein one pouch contains a test strip and a scoop. In embodiments, a package comprises two pouches, wherein one pouch is a reservoir pouch. In embodiments, a package comprises two pouches, wherein one pouch is a reservoir pouch, and the reservoir pouch contains a test strip. In embodiments, a package comprises two pouches, wherein one pouch is a reservoir pouch, and the reservoir pouch contains a scoop. In embodiments, a package comprises two pouches, wherein one pouch is a reservoir pouch, and the reservoir pouch contains a test strip and a scoop.

[0094] In embodiments, a package comprises two pouches, wherein a first pouch contains a test strip and a second pouch contains a scoop. In embodiments, a package comprises two pouches, wherein a first pouch is a reservoir pouch, and the reservoir pouch contains a test strip, and a second pouch contains a scoop. In embodiments, a package comprises two pouches, wherein a first pouch is a reservoir pouch, and the reservoir pouch contains a scoop, and a second pouch contains a test strip. In embodiments, a package comprises two pouches, wherein a first pouch is a reservoir pouch, and wherein a second pouch contains a test strip and a scoop.

[0095] In embodiments, a package comprises three pouches. In some such embodiments, a first pouch contains a test strip, a second pouch contains a scoop, and a third pouch contains a paper guide.

[0096] In embodiments, a pouch containing a test strip also contains a desiccant. FIG. 9 for example depicts a test kit comprising pouch 901, which contains test strip 903 and also contains desiccant bag 904.

[0097] In embodiments, a package is designed to remain closed until opened for use. a. Pouches

[0098] In embodiments, a package comprises one or more pouches. A "pouch" is an enclosed interior volume of a package, which may be structured to contain a solid or liquid. In embodiments, packaging material (“material”) is structured to form a plurality of pouches. In embodiments, material is structured to form a single pouch. In embodiments, material is structured to form two or more pouches. In embodiments, material is structured to form two pouches. In embodiments, material is structured to form three or more pouches. In embodiments, material is structured to form three pouches.

[0099] In embodiments, a package comprises two or more pouches. In embodiments, a package comprises two pouches. In embodiments, a package comprises three or more pouches. In embodiments, a package comprises three pouches. In embodiments, a package comprises a plurality of pouches.

[0100] In embodiments, a pouch is connected to another pouch. In embodiments, a pouch is separably connected to another pouch (e.g., by a separable connection), such that the pouches are designed to be separated by a user. In embodiments, a pouch is inseparably connected to another pouch, such that the two pouches are not designed to be separated by a user.

[0101] In embodiments, a pouch is watertight, or otherwise impermeable to water within tolerances understood to those in the art. In embodiments, a pouch is airtight, or otherwise impermeable to air within tolerances understood to those in the art. In embodiments, a pouch is both airtight and watertight, or otherwise impermeable to both air and water within tolerances understood to those in the art.

[0102] In embodiments, a pouch has a transparent or translucent portion that allows a user to view the interior of the pouch. Materials capable of such transparency or translucency, and their use in the manufacture of the disclosed packages and disclosed test kits, will be understood to those in the art.

[0103] For example, a package may comprise a pouch having a transparent or translucent window, such as in the exemplary package depicted in the Figures, e.g., in FIGS. 2, 4, 6, and 8-10.

[0104] A “window,” such as in a pouch, refers to any portion of the pouch, of any shape, that is either transparent or translucent, and allows light to pass through or permits at least partial visibility therethrough.

[0105] “Transparency” and “translucency” herein, unless context demands otherwise, may refer to any degree of transparency or translucency, including materials that are substantially transparent, substantially translucent, partially transparent, partially translucent, and degrees of transparency and translucency, such as (for transparency) 10% transparent, 20% transparent, 30% transparent, 40% transparent, 50% transparent, 60% transparent, 70% transparent, 80% transparent, 90% transparent, 95% transparent, and greater than 95% transparent, including 100% transparent. The measurement of transparency or translucency will be according to ordinary skill in the art. It will be appreciated that degrees of “opacity” also may be used to describe or claim disclosed embodiments, such as disclosed pouches or windows thereof.

[0106] Wherein a pouch comprises a transparent or translucent window, the interior of the pouch may comprise a material used to enhance visibility, such as a metallic foil material, which is viewable through the window, and designed to improve a user’s visibility of the contents of the pouch, such as the level of solvent.

[0107] In embodiments, a pouch is designed to remain closed until opened for use. In embodiments, a package comprises a plurality of pouches, and each pouch is designed to remain closed until opened for use. / . Reservoir Pouches

[0108] In embodiments, a pouch is structured to contain a solvent. In embodiments, a pouch is structured to form a reservoir (which may in embodiments be referred to as a “reservoir pouch”). For example, in the exemplary package of FIG. 1, pouch 107 is a reservoir pouch structured to contain a solvent.

[0109] In embodiments, a package comprises one or more measurement marks. In embodiments, a pouch comprises one or more measurement marks. In one example, where a pouch (e.g., a reservoir pouch) has a transparent or translucent window, one or more measurement marks are printed on the window of thepouch to aid a user with accurately interpreting the amount of a substance (e.g., a drug sample, a solvent) in the pouch. In embodiments, a measurement mark represents a unit, such as a volume unit (e.g., milliliters, mL), to inform a user of the amount of a substance in the pouch. In embodiments, a measurement mark comprises a horizontal marking defining a predetermined unit (e.g., a volume unit). In embodiments, a measurement mark measures the number of scoopfuls of a drug sample present in the pouch. In embodiments, a measurement mark measures the volume of solvent present in the pouch.

[0110] An exemplary reservoir pouch having a translucent portion and measurement marks is depicted in the Figures, such as in FIGS. 2, 4, 6, 7B-C, 8A, 8D, and 16.

[0111] In embodiments, a pouch comprises between one and 10 measurement marks. In embodiments, a pouch comprises between four and eight measurement marks. In embodiments, a pouch comprises six measurement marks, or eight measurement marks. In embodiments, the measurement marks are numbered.

[0112] In one example, a pouch comprises eight measurement marks, numbered “1” through “8,” as depicted in the Figures, such as in FIGS. 2, 4, 6, 7B-C, 8A, 8D, and 16. In embodiments, the number corresponding to a measurement mark refers to the number of scoopfuls of drug sample to be added when the solvent is filled to that mark. In embodiments, each measurement mark indicates a volume of solvent in the pouch when the solvent is filled to that mark. In this example, the measurement mark numbered “1” represents 25 mL of solvent. In embodiments, each mark above the mark numbered “1” represents an additional volume of solvent. In embodiments, each mark above the mark numbered “1” represents an additional 5 mL of solvent. Hence, in this example, the marks numbered “2,” “3,” “4,” “5,” “6,” “7,” and “8” represent 30 mL, 35 mL, 40 mL, 45 mL, 50 mL, 55 mL, and 60 mL, respectively.

[0113] In embodiments, a pouch is structured to allow for a solvent (e.g., water) and a drug sample to be combined into a solution for testing for a contaminant according to a disclosed method. For example, embodiments of disclosed methods may comprise adding a drug sample into a reservoir pouch, then adding a volume of solvent (e.g., water) to the pouch, wherein the volume of solvent added may depend on the amount of a drug sample desired to be tested.

[0114] Exemplary depictions of a reservoir pouch of a test kit filled with solvent, such as water, are shown in the Figures, for example in FIGS. 7B, 7C, 8A, and 8D.

[0115] In embodiments, the capacity of a pouch is between about 10 mL and 200 mL. In embodiments, the capacity of a pouch is between about 10 mL and 150 mL. In embodiments, the capacity of a pouch is between about 10 mL and 100 mL. In embodiments, the capacity of a pouch is between about 20 mL and 200 mL. In embodiments, the capacity of a pouch is between about 20 mL and 150 mL. In embodiments, the capacity of a pouch is between about 50 mL and 200 mL. In embodiments, the capacity of a pouch is between about 50 mL and 150 mL. In embodiments, the capacity of a pouch is between about 50 mL and 75 mL. In embodiments, the capacity of a pouch is between about 75 mL and 100 mL. In embodiments, the capacity of a pouch is about 74 mL. In embodiments, the capacity of a pouch is about 50 mL, 55 mL, 60 mL,65 mL, 70 mL, 71 mL, 72 mL, 73 mL, 74 mL, 75 mL, 76 mL, 77 mL, 78 mL, 79 mL, or 80 mL. In embodiments, the capacity of a pouch is between about 20 mL and 80 mL. In embodiments, the capacity of a pouch is between about 30 mL and 60 mL. In embodiments, the capacity of a pouch is about 30 mL, 35 mL, 40 mL, 45 mL, 50 mL, 55 mL, or 60 mL.

[0116] In embodiments, a pouch is structured to contain another test kit component. For example, in the exemplary package of FIG. 1, pouch 106 contains a test strip, and pouch 107 contains a scoop.

[0117] In embodiments, a pouch contains a test strip. In embodiments, a pouch contains a scoop. In embodiments, a pouch contains a desiccant. In embodiments, a pouch contains a paper guide. A test strip, a scoop, a desiccant, and a paper guide are understood by the description below and the knowledge in the art.

[0118] In embodiments, a reservoir pouch is designed to remain closed until opened for use. In embodiments where a package comprises a single reservoir pouch, the reservoir pouch is designed to remain closed until opened for use. In embodiments where a package comprises two or more reservoir pouches, each reservoir pouch is designed to remain closed until opened for use. b. Test Strips

[0119] In embodiments, a package comprises a test strip. In embodiments, a pouch contains a test strip. In embodiments, a test strip is attached or affixed to an exterior surface of a package.

[0120] In embodiments, a package comprises a single test strip. In embodiments, a package comprises one or more test strips. In embodiments, a package comprises more than one test strip.

[0121] In embodiments, a test strip is designed to test for the presence of (i.e., detect) a chemical compound. In embodiments, the compound is a contaminant, such as a drug contaminant in a drug sample. Examples of suitable test strips are known to those of skill in the art, and may be commercially available or manufactured according to known methods.

[0122] In embodiments, the contaminant is fentanyl. In embodiments the drug sample is fentanyl. In embodiments, the test strip is designed to detect fentanyl. Herein, a test strip may be referred to by a chemical compound or a contaminant it is designed to detect; for example, a test strip designed to detect the presence of fentanyl may be referred to as a “fentanyl test strip.”

[0123] An exemplary fentanyl test strip is shown as 903 in FIG. 9, in FIG. 10, and as 1201 in FIG. 12.

[0124] In embodiments, the contaminant is a fentanyl analog. In embodiments, a test strip is designed to detect the presence of a fentanyl analog. In embodiments, the contaminant is a fentanyl derivative. In embodiments, a test strip is designed to detect the presence of a fentanyl derivative.

[0125] In embodiments, a test strip is designed to detect more than one chemical compound. In embodiments, a fentanyl test strip is designed to detect fentanyl and one or more other compounds. In embodiments, a fentanyl test strip is designed to detect fentanyl and one or more fentanyl analogs. In embodiments, a fentanyl test strip is designed to detect fentanyl and one or more fentanyl derivatives. In embodiments, a fentanyl test strip is designed to detect fentanyl and one or more other contaminants.

[0126] Examples of fentanyl analogs, detectable using a test strip designed therefor, are known in the art and include phenylfentanyl, 4-methoxybutyrylfentanyl, 4-fluorobutyrylfentanyl, acetylfentanyl, methoxyacetylfentanyl, acrylfentanyl, desmethylfentanyl, N-methyl norfentanyl, 4-fluoroisobutyrylfentanyl, cyclopropylfentanyl, THF-fentanyl, 3-furanylfentanyl, furanylfentanyl, 3-methylbutyrylfentanyl, ocfentanil, 4-fluorocyclo- propylbenzylfentanyl, para-fluoro 4-ANBP, carfentanil, N-benzyl furanylnorfentanyl, MT-45, and 4-ANPP.

[0127] In embodiments, a test strip is designed to detect fentanyl and at least one fentanyl analog. In embodiments, a test strip is designed to detect fentanyl and at least 5 fentanyl analogs. In embodiments, a test strip is designed to detect fentanyl and at least 10 fentanyl analogs. In embodiments, a test strip is designed to detect fentanyl and at least 20 fentanyl analogs.

[0128] In embodiments, the contaminant is a benzodiazepine. In embodiments, a test strip is designed to detect a benzodiazepine. An exemplary benzodiazepine test strip 1202 is shown in FIG. 12.

[0129] In embodiments, a test strip is designed to detect alprazolam, clonazepam, and diazepam.

[0130] In embodiments, a test strip is designed to detect any one or more of alprazolam, bromazepam, chlordiazepoxide, clobazam, clonazepam, clorazepate, diazepam, estazolam, etizolam, flunitrazepam, flurazepam, flutoprazepam, halazepam, ketazolam, loprazolam, lorazepam, lormetazepam, midazolam, nimetazepam, nitrazepam, oxazepam, prazepam, quazepam, temazepam, tetrazepam, and triazolam.

[0131] In embodiments, the contaminant is xylazine. In embodiments, a test strip is designed to detect xylazine. An exemplary xylazine test strip 1203 is shown in FIG. 12.

[0132] In embodiments, the contaminant is another drug compound. Test strips designed to detect other drug compounds will be known to those in the art.

[0133] In embodiments, the contaminant is a non-drug compound. Test strips designed to detect non-drug compounds, such as the non-drug contaminants disclosed herein, will be known to those in the art.

[0134] In embodiments, a test strip is designed to detect a combination of two or more contaminants, such as two or more drug contaminants, and may detect such contaminants together in a test sample.

[0135] A test strip may detect a contaminant (or multiple contaminants) using any suitable technology known in the art. In embodiments, a test strip detects a contaminant using a lateral flow test (LFT) or lateral flow assay (LFA). A test strip using a LFA may use a lateral flow immunoassay (LFIA). LFIA methods include lateral flow immunochromatographic assay and competitive lateral flow immunoassay (CLFIA).

[0136] Without being bound by theory or by any specific disclosure, in embodiments where a test strip uses a lateral flow competitive immunoassay, the test strip may comprise: (1) a solid support matrix facilitating lateral flow, defined by a first end and a second end; (2) a test line with immobilized particles on the solid support matrix; (3) a control line with immobilized particles on the solid support matrix; and (4) a conjugate zone with mobilizable control particles on the solid support. When the test strip is used, the first end is placed in a solution containing the drug sample, allowing the solution to migrate through capillary action toward the conjugate zone, thereby mobilizing both the control particles and the drug sample towardthe test and control lines. In instances where a contaminant is present in the drug sample, it competes with the control particles for binding at the test line. Consequently, in the absence of a contaminant, the control particles bind at the test line, creating a visible line on the solid support matrix. Conversely, if a contaminant is present, it prevents the control particles from binding at the test line, resulting in no visible line.

[0137] In embodiments, a test strip provides a means for identifying a presence or an absence of a compound, such as a contaminant. In embodiments, the means for identifying the presence of the compound is a testing line. In embodiments, the means for identifying the absence of the compound is a control line.

[0138] In embodiments, a test strip comprises a marking to guide a user in the correct use of the test strip. For example, the test strip may have a marking indicating the maximum depth the test strip should be inserted into a solvent, such as water. In another example, a test strip may have a marking indicating which end of the test strip should be held by a user. Such markings are depicted in the exemplary fentanyl test strip of FIG. 10, and the exemplary test strips 1201, 1202 and 1203 shown in FIG. 12.

[0139] In embodiments, a package comprises a printed section labeled “Results,” comprising images of Positive, Negative, and Invalid test result examples. In embodiments, users can can cross-reference their test strip with the images in the “Results” section to determine the presence or not of a contaminant, and therefore to provide a visual confirmation of the results (e.g., “T” for “Test” or positive; “C” for “Control” together with T, for negative; C alone or no marking for an invalid test). c. Scoops

[0140] In some embodiments, a package comprises a scoop. In embodiments, a pouch contains a scoop. In embodiments, a scoop is attached or affixed to an exterior surface of a package.

[0141] In embodiments, a package comprises a single scoop. In embodiments, a package comprises one or more scoops. In embodiments, a package comprises more than one scoop.

[0142] In embodiments, a scoop is designed to measure a known quantity of a test sample, for example a drug sample. In embodiments, a scoop is designed to measure a predetermined quantity of a drug sample to add to a pouch. In embodiments, a scoop is designed to measure a predetermined quantity of a powdered drug sample to add to a pouch. In embodiments, a scoop is designed to measure a predetermined quantity of a drug sample to add to a pouch to achieve a specified concentration. In embodiments, a scoop is made of a material that resists static buildup, or is treated to reduced static buildup (e.g., with an anti-static coating or spray), to prevent a powdered drug sample from sticking to the scoop. In embodiments, a scoop is designed for precision and to ensure a specified quantity is measured.

[0143] Although referred to herein as a “scoop,” such scoops also may be referred to as “microscoops.”

[0144] In embodiments, a scoop has a predetermined capacity. In embodiments, the “capacity” of a scoop refers to the amount of a drug sample contained in a level scoopful of a powdered drug sample.

[0145] In embodiments, a scoop has a capacity defined in units of volume, i.e., the scoop is designed to measure a specified unit of volume. In embodiments, a scoop has a capacity of between about 5 pL (0.005mL) and 20 pL of a test sample, such as a drug sample. In embodiments, a scoop has a capacity of about 5 pL, 6 pL, 7 pL, 8 pL, 9 pL, 10 pL, 11 pL, 12 pL, 13 pL, 14 pL, 15 pL, 16 pL, 17 pL, 18 pL, 19 pL, or 20 pL. In embodiments, a scoop has a capacity of about 10 pL.

[0146] In embodiments, a scoop has a capacity defined in units of mass, i.e., the scoop is designed to measure a specified unit of mass. In embodiments, a scoop has a capacity of between about 5 mg and 20 mg of a test sample, such as a drug sample. In embodiments, a scoop has a capacity of about 5 mg, 6 mg, 7 mg, 8 mg, 9 mg, 10 mg, 11 mg, 12 mg, 13 mg, 14 mg, 15 mg, 16 mg, 17 mg, 18 mg, 19 mg, or 20 mg. In embodiments, a scoop has a capacity of about 10 mg.

[0147] An exemplary scoop 905 is illustrated in FIG. 9. d. Desiccant

[0148] In embodiments, a package contains a desiccant. In embodiments, a pouch contains a desiccant. Exemplary desiccants include silica gel, calcium chloride, activated clay, calcium oxide, molecular sieves, activated carbon, and others known to those of skill in the art. The desiccant may be packaged in a bag, sachet, packet, or other suitable container. In embodiments, a pouch comprising a test strip further comprises a desiccant. In embodiments, a pouch comprising a scoop further comprises a desiccant.

[0149] FIG. 9 illustrates desiccant bag 904 as a component of an exemplary embodiment of a package. e. Information, Instructions, and Guides

[0150] In embodiments, a package comprises information, such as instructions for the use of a test kit, information about the interpretation of test results, information about what to do when there are positive test results, or information about the contaminant(s) that a test kit is designed to detect.

[0151] In embodiments, information is provided as a printed guide, such as a paper guide. In embodiments, the paper guide is contained in a pouch.

[0152] In embodiments, information is printed on a surface of a package, such as stamped, embossed, or otherwise incorporated onto the package using any other suitable means (e.g., on an adhesive label).

[0153] In embodiments, a package comprises instructions that provide a user with directions for using the package, such as according to a disclosed method. In embodiments, a package comprises instructions that direct a user to create a solution comprising a drug sample (e.g., by opening the package, adding the drug sample into a reservoir pouch, and adding a solvent into the reservoir pouch to dissolve the drug sample in the solvent). In embodiments, a package comprises instructions that direct a user to test a drug sample for a contaminant, such as according to a disclosed method. In embodiments, a package comprises instructions that assist a user with interpreting the results of testing a drug sample for a contaminant, to determine the presence or absence of a contaminant in the sample.

[0154] In embodiments, a package comprises a quick-response (“QR”) code or other means of linking to a website, a smartphone application (“app”) for download or use, or the like, such as printed on a surface of a package, or included on a paper guide. A linked website or mobile app may provide further instructionsfor use, a test result reporting survey or questionnaire, or any other relevant information.

[0155] An exemplary package having information directly on an exterior surface thereof, including a QR code, is depicted in the Figures, such as in FIGS. 2, 4, 6, and 16.

[0156] Exemplary illustrations of a smartphone test kit app, such as for drug checking using a disclosed test kit according to exemplary embodiments, is illustrated in FIGS. 14A and 14B. An exemplary smartphone test kit app, such as illustrated therein, also is available at dosetest.com / test-kit-app / .D. Materials

[0157] In some aspects herein are disclosed test kits, where such test kits are integrated single units provided as a package. A disclosed test kit or disclosed package is made from one or more materials, which herein may be referred to as a “packaging material” or just a “material.” Packaging material suitable for disclosed test kits will be understood from the disclosure and the knowledge in the art.

[0158] In embodiments, a package comprises multiple packaging materials in separate layers of a laminate, as parts of a composite material, or in any combination, as described herein or as known in the art.

[0159] In embodiments, a packaging material comprises a plastic, such as a synthetic or semi-synthetic polymer material. In embodiments, a packaging material comprises a thermoplastic polymer. A “thermoplastic polymer” also includes a thermoplastic copolymer. Thermoplastic polymers are known to those of skill in the art, and include polypropylene (PP), polyethylene (PE) (e.g., low-density polyethylene, LDPE), polyamides (e.g., nylon), ethylene vinyl alcohol (EVOH), polyvinyl alcohol, ethylene acrylic acid, polyolefin carboxylic acid copolymers, polyesters (e.g., Mylar®), polycarbonates, polyvinyl acetates, polyvinyl chlorides, poly(oxymethylene), polyacrylonitriles, styrene copolymers, polyacrylates, polymethacrylates, poly(methyl methacrylates), polystyrene / polyfmethyl methacrylate) copolymers, polyetherimides, polysulfones, and combinations thereof. In embodiments, a packaging material comprises PP. In embodiments, a packaging material comprises PE. In embodiments, a packaging material comprises LDPE. In embodiments, a packaging material comprises PP and PE. In embodiments, a packaging material comprises PP and LDPE. In embodiments, a packaging material comprises plastic-treated paper or plastic-coated paper. In embodiments, packaging material comprises a plastic-treated paper or plastic-coated paper, wherein the plastic is PE (e.g., LDPE), PP, or a combination thereof. Other such materials will be readily appreciated.

[0160] Thermoplastic polymers, such as described herein, can be processed into films that exhibit a range of configurations, tailored according to desired film properties. Such properties can be adjusted by modifying aspects like film thickness or, for multilayer films, by altering the number of layers, the chemical characteristics of each layer (e.g., hydrophobic or hydrophilic), and the polymers of the polymeric layers.

[0161] In embodiments, a packaging material is a flexible material. In general, but without being bound by theory, a “flexible” material is one that can bend, fold, or deform under normal handling, storage, and transport conditions without cracking or breaking. The flexibility of a material and its suitability for use as a flexible packaging material will be known to those of skill in the art.

[0162] In embodiments, a packaging material is substantially impermeable to liquids and / or gasses. For example, in embodiments, the material resists penetration or passage of water (and / or other solvents) and / or oxygen (and / or other gasses) under normal storage and handling conditions, thereby protecting the components from external contamination or degradation (e.g., oxidation). The permeability of a material and its suitability for use as a packaging material in disclosed embodiments will be known to those of skill.

[0163] In embodiments, a packaging material has high tear resistance or is tear-resistant. The tear resistance of a material and its suitability for use as a packaging material in disclosed embodiments will be known to those of skill. In embodiments, a tear-resistant material enables a package to withstand punctures or tears that could compromise the integrity of the package during handling, transport, or storage.

[0164] In embodiments, a packaging material has high chemical resistance or is chemically resistant. The chemical resistance of a material and its suitability for use as a packaging material in disclosed embodiments will be known to those of skill. In embodiments, a chemically resistant material protects a package from chemical degradation when exposed to certain chemicals or solvents, and enhances or ensures the shelf-life of a package and its components.

[0165] In embodiments, a package is made from one or more sheets of material. A single “sheet” in some embodiments may refer to a laminate material comprising multiple layers of material, for example a multilayer plastic material, such as comprising multiple layers of one or more plastics, including formed by coextrusion, lamination, coating, or the like, and provided as a single sheet.

[0166] In embodiments, a package is made from a single sheet of material. In embodiments, an advantage of a disclosed test kit is that it is made from a single sheet of material. In embodiments, a test kit made from a single sheet of material has a folded bottom edge, has side-by-side subunits wherein each subunit has a sealed top edge, a sealed right side edge, and a sealed left side edge, and wherein the subunits are separably connected, such as frangibly connected, together forming an integrated test kit.

[0167] In other embodiments, a package is made from more than one sheet of material, such as from two sheets of material, or more than two sheets of material. In embodiments, a test kit made from two sheets of material has side-by-side subunits wherein each subunit has a sealed bottom edge, a sealed top edge, a sealed right side edge, and a sealed left side edge, and wherein the subunits are separably connected, such as frangibly connected, together forming an integrated test kit.

[0168] In embodiments, a package comprises a folded bottom edge. In embodiments, a package is made from a sheet of material, wherein such material is folded upon itself to provide a folded bottom edge of the package. In embodiments, a package comprises two or more subunits comprising a folded bottom edge, for example two or more side-by-side subunits comprising a folded bottom edge.

[0169] In embodiments, a package is sealed. “Sealed” refers to two or more surfaces of a package being joined or bonded to form a continuous or substantially continuous closure (a “seal”). A seal may be structured to contain one or more components within a pouch, structured to close a pouch and provide abarrier to external moisture (excluding permeability inherent to a package surface itself), or the like.

[0170] In embodiments, a package comprises a sealed bottom edge. In embodiments, a package comprises two or more subunits, each subunit comprising a sealed bottom edge. In embodiments, a package comprises two or more subunits, each subunit comprising a sealed bottom edge, and wherein the subunits are separably connected side-by-side to provide a single bottom edge, the single bottom edge being a sealed bottom edge.

[0171] In embodiments, a package comprises a sealed top edge. In embodiments, a package comprises two or more subunits, each subunit comprising a sealed top edge. In embodiments, a package comprises two or more subunits, each subunit comprising a sealed top edge, and wherein the subunits are separably connected side-by-side to provide a single top edge, the single top edge being a sealed top edge.

[0172] In embodiments, a package comprises sealed side edges, such as a sealed right side edge and a sealed left side edge. In embodiments, a package comprises two or more subunits, each subunit comprising sealed side edges, such as each subunit comprising a sealed right side edge and a sealed left side edge. In embodiments, a package comprises a first subunit and a second subunit, each subunit comprising sealed side edges, wherein a sealed side edge of the first subunit and a sealed side edge of the second subunit are separably connected, such as frangibly connected, along the length of the side edges.

[0173] In embodiments, a package comprises a sealed top edge structured to enclose an interior space of the package. In embodiments, a package comprises one or more sealed top edges, such as two subunits comprising sealed top edges, structured to enclose one or more interior spaces of the package, such as two interior spaces of the package, for example two pouches.

[0174] In embodiments, a package comprises sealed side edges structured to enclose an interior space of the package. In embodiments, a package comprises two subunits, each subunit comprising sealed side edges, structured to enclose two interior spaces of the package, for example two pouches.

[0175] In embodiments, a package comprises sealed top and side edges structured to enclose an interior space of the package. In embodiments, a package comprises two subunits, each subunit comprising sealed top and side edges, structured to enclose two interior spaces of the package, for example two pouches, i.e. , two pouches each enclosing an interior space.

[0176] In embodiments, a package comprises sealed bottom, top, and side edges structured to enclose at least one interior space of the package. In embodiments, a package comprises two subunits, each subunit comprising sealed bottom, top, and side edges, structured to enclose two interior spaces of the package, for example two pouches, i.e., two pouches each enclosing an interior space.

[0177] In embodiments, a package comprises two or more subunits wherein each subunit has a folded bottom edge, a sealed top edge, a sealed right side edge, and a sealed left side edge, and wherein the subunits are separably connected, such as frangibly connected, together forming an integrated test kit. In embodiments, a package comprises two or more side-by-side subunits wherein each subunit shares a foldedbottom edge and shares a sealed top edge, and wherein each subunit has a sealed right side edge, and a sealed left side edge, and wherein the subunits are separably connected, such as frangibly connected, together forming an integrated test kit with a folded bottom edge and a sealed edge.

[0178] In embodiments, a package comprises two or more subunits wherein each subunit has a sealed bottom edge, a sealed top edge, a sealed right side edge, and a sealed left side edge, and wherein the subunits are separably connected, such as frangibly connected, together forming an integrated test kit. In embodiments, a package comprises two or more side-by-side subunits wherein each subunit shares a sealed bottom edge and shares a sealed top edge, and wherein each subunit has a sealed right side edge, and a sealed left side edge, and wherein the subunits are separably connected, such as frangibly connected, together forming an integrated test kit with a folded bottom edge and a sealed edge.

[0179] In embodiments, a package comprises a folded bottom edge, sealed side edges, and a sealed top edge. In embodiments, a package comprises two or more subunits comprising folded bottom edges, sealed side edges, and sealed top edges. In embodiments, a package comprises two or more subunits comprising folded bottom edges, sealed side edges, and sealed top edges, structured to enclose two or more interior spaces of the package, for example two or more pouches.

[0180] In embodiments, a package comprises a sealed bottom edge, sealed side edges, and a sealed top edge. In embodiments, a package comprises two or more subunits comprising sealed bottom edges, sealed side edges, and sealed top edges. In embodiments, a package comprises two or more subunits comprising sealed bottom edges, sealed side edges, and sealed top edges, structured to enclose two or more interior spaces of the package, for example two or more pouches.

[0181] Other embodiments comprising further subunits, such as additional pouches, will be appreciated.

[0182] An exemplary sealed package 100 is illustrated in FIG. 1 and FIG. 2. In this exemplary embodiment, the package comprises a front surface 101, a back surface 201, two side sealed edges 102 and 103, a folded bottom edge 104, and a top sealed edge 105. a. Separable Connections

[0183] In embodiments, a package comprises two or more pouches. In embodiments, the two or more pouches are separably connected. In embodiments, the separable connection is a frangible connection.

[0184] Examples of pouches separably connected with a frangible connection include pouches separated by a perforation line, a tearable perforation, a tear line, a score line, pressure-sensitive adhesive, detachable tabs, laser-cut frangible lines, micro-perforations, ultrasonically welded or heat-sealed weak points, or any other similar connection structured to allow the pouches to be separated by an individual with minimal manual force, such as by pulling the pouches apart from each other.

[0185] These and other frangible connections, and preparing separably connected pouches using such connections, will be known in the art, including for different types of plastics and other pouch materials.

[0186] In embodiments, a package comprises two or more pouches separably connected, such as by afrangible connection along the length of at least one side of each pouch, so that the pouches are connected side by side. In embodiments, a package comprises two pouches separably connected, such as by a frangible connection along the length of one side of each pouch, so that the pouches are connected side by side. In embodiments, a package comprises three pouches separably connected, such as by a frangible connection along the length of two sides of a middle pouch, and one side of each of a left and a right pouch, so that the pouches are connected side by side by side.

[0187] The exemplary embodiments of FIGS. 1-9 comprise two side-by-side pouches 106 and 107, separably connected by frangible connection 108.

[0188] The exemplary embodiments of FIGS. 15-16 comprise three side-by-side-by-side pouches 1501, 1502 and 1503, separably connected by frangible connections 1504 and 1505.

[0189] In embodiments, a package comprises two or more pouches separably connected, wherein the pouches cannot be reattached once separated. In other embodiments, a package comprises two or more pouches separably connected, wherein the pouches can be reattached once separated.

[0190] For example, two or more pouches may be separably connected by an adhesive strip (comprising, e.g., a pressure-sensitive adhesive) that permits separation of the pouches and subsequent reattachment by pressing the adhesive surfaces together. In another example, two or more pouches may be separably connected by an interlocking connector (e.g., with each pouch comprising ridges or tracks complementary to those on another pouch) that can be pulled apart to separate the pouches, and which permits reattaching the pouches by pressing the connector together.

[0191] For example, FIGS. 1-2 are front and back views of an exemplary package where the pouches are separably connected, but wherein the pouches are not yet separated. FIGS. 3-4 show the same package, from the same views, but with the pouches separated (e.g., manually pulled apart).

[0192] FIGS. 5-6 show the same exemplary package, from the same views as FIGS. 3-4, with the pouches opened, for example having been torn open by hand (e.g., exposing their interior volumes). b. Opening Means

[0193] In embodiments, a package comprises an opening means, such that the package is openable. In embodiments, a pouch comprises an opening means, such that the pouch is openable, for example openable by hand, i.e., manually openable, e.g., readily openable. In embodiments where a package comprises two or more pouches, each pouch may be independently openable, allowing a user to access the interior of each pouch separately from any other pouch. In embodiments where a package comprises two or more separably connected pouches, the package may be structured to enable a user to separate the pouches without opening them, permitting the user to subsequently open each pouch independently. In other embodiments where a package comprises two or more separably connected pouches, the package may be structured to enable the user to open both pouches with a single manual motion, without first separating the pouches.

[0194] Examples of opening means for pouches include perforation lines, a tearable perforations, tearlines, score lines, adhesive strips, pressure-sensitive adhesives, detachable tabs, laser-cut frangible lines, micro-perforations, ultrasonically welded or heat-sealed weak points, and any other similar connection designed to allow a pouch to be opened by an individual with minimal manual force.

[0195] These and other opening means, and preparing pouches having such means, will be known in the art, including for different types of plastics and other pouch materials.

[0196] In embodiments, an opening means is watertight, or otherwise impermeable to water within suitable tolerances known in the art. Hence, in embodiments where a pouch is watertight, the opening means will not compromise the impermeability of the pouch to water. In embodiments, an opening means is airtight, or otherwise impermeable to air within tolerances understood to those in the art. Hence, in embodiments where a pouch is air, the opening means will not compromise the impermeability of the pouch to air.

[0197] In embodiments, an opening means is closable, i.e., allows a user to close the opening means to close the package after it has been opened. A closable opening means may be, e.g., an adhesive strip (comprising, e.g., a pressure-sensitive adhesive) enabling a user to open a package by pulling apart the adhesive strip, after which the package may be closed by pressing the strip together. In embodiments, an opening means is not closable. A not closable opening means may comprise, e.g., a perforated line enabling a user to open the package by tearing it along the perforated line, after which the package cannot be closed.

[0198] In embodiments, a package or a pouch comprises a tear notch. In embodiments, the tear notch is positioned below the top sealed edge. In embodiments, the tear notch is structured to enable a user to remove the top sealed edge of the pouch, or of the package, so as to open one or more pouches of the package. For example, the exemplary package illustrated in FIG. 1 comprises a tear notch 109 structured to enable a user to remove the top sealed edge of the package, so as to open both pouches of the package. In embodiments, where a package or a pouch is opened by being torn open, it is not closable.

[0199] In embodiments, a package comprises a front surface and a back surface, and an outer perimeter defined by two side edges (a left side edge and a right side edge), a bottom edge, and a top edge.E. Methods of Manufacture

[0200] In some aspects are provided methods of manufacturing disclosed integrated single use tests kits (or “packages”).

[0201] In embodiments, a package is manufactured from one or more packaging materials, such as those disclosed herein or otherwise known to those of skill. In embodiments, a package is manufactured from one or more sheets of material. In embodiments, a package is manufactured from more than one sheet of material. In embodiments, a package is manufactured from two sheets of material. In embodiments, a package is manufactured from two or more sheets of material.

[0202] In embodiments, a package is manufactured from a laminate material comprising multiple layers of material. In embodiments, a package is manufactured from a multilayered laminate material, such as a multilayered laminate plastic material. In embodiments, a package is manufactured from a multilayeredlaminate plastic material comprising multiple layers of one or more plastics. In embodiments, a package is manufactured from a single sheet of material. In embodiments, a package is manufactured from a single sheet of laminate material. In embodiments, a package is manufactured from a single sheet of a multilayer laminate plastic material. In embodiments, a package is manufactured from a multilayer laminate plastic material comprising multiple layers of one or more plastics.

[0203] In embodiments, a multilayer laminate plastic material used in the manufacture of a package comprises an opaque layer. An opaque layer may comprise pigments or fillers to achieve a desired opacity, or may be coated or printed with an opaque component, such as ink. In embodiments, a multilayer laminate plastic material used in the manufacture of a package comprises a translucent layer. In embodiments, a multilayer laminate plastic material used in the manufacture of a package comprises a transparent layer. In embodiments, a multilayer laminate plastic material used in the manufacture of a package comprises an opaque layer and a translucent or transparent layer. In embodiments, a multilayer laminate plastic material used in the manufacture of a package comprises an opaque layer and a translucent layer. In embodiments, a multilayer laminate plastic material used in the manufacture of a package comprises an opaque layer and a transparent layer.

[0204] In embodiments, a multilayer laminate plastic material used in the manufacture of a package comprises a thermoplastic polymer layer. In embodiments, a multilayer laminate plastic material used in the manufacture of a package comprises a polyethylene layer (PE). In embodiments, a multilayer laminate plastic material comprises a polypropylene (PP) layer. In embodiments, a multilayer laminate plastic material comprises a polyethylene terephthalate (PET) layer. In embodiments, a multilayer laminate plastic material comprises a PE layer and a PP layer. In embodiments, a multilayer laminate plastic material comprises a PE layer and a PP layer, wherein the PE layer is translucent or transparent. In embodiments, a multilayer laminate plastic material comprises a PE layer and a PP layer, wherein the PP layer is opaque. In embodiments, a multilayer laminate plastic material comprises a PE layer and a PP layer, wherein the PE layer is translucent or transparent and the PP layer is opaque. In embodiments, a multilayer laminate plastic material comprises a PE layer and a PET layer. In embodiments, a multilayer laminate plastic material comprises two or more PE layers. In embodiments, a multilayer laminate plastic material comprises two PE layers, wherein a first PE layer is translucent or transparent, and a second PE layer is opaque. In embodiments, a multilayer laminate plastic material comprises a layer of PE that has been coextruded with another polymer (e.g., PP, PET, ethylene vinyl alcohol, a polyamide, a polyacrylonitrile, etc.).

[0205] In embodiments, a method of manufacturing a package comprises cutting a sheet of material to specified dimensions based on the intended dimensions of the package. Suitable means for cutting a sheet of material include, for example, die cutting, laser cutting, water jet cutting, CNC cutting, thermal cutting, guillotine cutting, rotary cutting, and other means known to those in the art.

[0206] In embodiments, the sheet of material is cut into a rectangular shape. In embodiments, thesheet of material is cut into a rectangular shape having a length that is greater than its width. In embodiments, the sheet of material is cut into a rectangular shape, where the length is approximately 1.25 times, 1 .5 times, 2 times, 2.5 times, or 3 times as long as the width. In embodiments, the sheet of material is cut into a rectangular shape, where the length is approximately 2 times as long as the width (i.e. , the length is approximately double the width).

[0207] In embodiments, a method of manufacturing a package comprises removing one or more portions of material from the sheet to provide one or more openings in the sheet. Suitable means for removing a portion of material from a sheet to provide an opening include cutting means (as described herein other otherwise known in the art), punching (e.g., die punching), laser etching, laser cutting, and other methods known in the art.

[0208] In embodiments, one portion of material is removed from a sheet, providing one opening in the sheet. In embodiments, two portions of material are removed from a sheet, providing two openings in the sheet. In embodiments, two or more portions of material are removed from a sheet, providing two or more openings in the sheet. In embodiments where a material comprises multiple layers, such as in a multilayer laminate plastic material, one or more portions of material may be removed from a single layer without removing material from any other layers. In embodiments where a material comprises a multilayer laminate plastic material having an opaque layer and a translucent or transparent layer, one or more portions of material may be removed from the opaque layer, thus providing one or more windows in the sheet.

[0209] In embodiments, a method of manufacturing a package comprises folding the sheet of material upon itself to create a folded sheet having one folded edge. In embodiments where a sheet of material has been cut into a rectangular shape, the sheet is folded along the length of the rectangle, providing an approximately square-shaped folded sheet of material having one folded edge. In embodiments, folding the sheet of material upon itself results in two layers of material joined at one folded edge (i.e., the “bottom” edge), and having two open side edges adjacent and perpendicular to the folded edge, and an open “top” edge opposite the folded bottom edge.

[0210] In embodiments, a method of manufacturing a package comprises closing the open side edges of the folded sheet, such as by sealing the two layers of material along each edge to form a continuous closure along each edge. Methods of sealing include heat sealing, adhesive bonding, ultrasonic welding, and other methods known in the art. In embodiments, closing each side edge provides a package having a one folded bottom edge, two sealed side edges adjacent and perpendicular to the bottom folded edge, an open top edge opposite the folded edge. In embodiments, closing each side edge provides a package having an interior space between the top and bottom layers of the material, and having a perimeter defined by the folded bottom edge, sealed side edges, and open top edge.

[0211] In embodiments, a method of manufacturing comprises structuring the package to form two or more pouches. In embodiments, two or more pouches are formed in the package by creating at least oneseparable connection between the right side edge and the left side edge of the package, wherein the separable connection is sealed along both sides of the connection thereby forming at least two pouches. In embodiments, the material is first sealed and then a separable connection is created along the length of the seal, such as by perforating the seal longitudinally, for example from the bottom edge to the top edge. In other embodiments, a separable connection is first created for example from the bottom edge to the top edge of the package, and then the material is sealed along the length of both sides of the separable connection.

[0212] In embodiments, a method of manufacturing a package comprises placing a scoop into the interior space of a pouch. In embodiments, a method of manufacturing a package comprises placing a test strip into the interior space of a pouch. In embodiments, a method of manufacturing a package comprises placing a desiccant into the interior space of a pouch. In embodiments, a method of manufacturing a package comprises placing a desiccant bag into the interior space of a pouch. In embodiments, a method of manufacturing a package comprises placing a test strip into the interior space of a pouch, and placing a desiccant bag into the interior space of the same pouch. In embodiments, a method of manufacturing a package comprising two or more pouches comprises placing a test strip into the interior space of a first pouch, placing a desiccant bag into the interior space of the first pouch, and placing a scoop into the interior space of a second pouch.

[0213] In embodiments, a method of manufacturing a package comprises closing the open top edge of the package, such as by sealing the two layers of material along the top edge to form a continuous closure along the top edge. In embodiments, closing the top edge of the package provides a package having a folded bottom edge, two sealed side edges, and a closed top edge.

[0214] In embodiments, a method of manufacturing a package comprises forming an opening means to the package. In embodiments, the opening means is formed by cutting, scoring, or perforating the material. For example, a tear notch may be formed by punching, laser engraving, or die-cutting a small notch below the top edge of the package.

[0215] In embodiments, two or more packages are provided together, such as provided in bulk, and provided together in any quantity, such as a quantity of 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 15, 20, 25, 30, 50, 100, or greater than 100 test kits, including numbers in between, and by a group of any such quantity, such as a group of 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 15, 20, 25, 30, 50, 100, or greater than 100 of a quantity of packages, such as a group of any quantity above. Among the advantages of the disclosure is the compact and efficient bulk provision of multiples of test kits, including by such quantities and by such groups of quantities.F. Methods of Testing Drug Samples

[0216] In some aspects are provided methods of detecting a contaminant in a drug sample using a disclosed test kit. For instance, one exemplary method comprises opening a pouch, adding a solvent into the pouch, adding a drug sample into the pouch, dipping a test strip into the pouch, and reading the test strip. Such methods are further described below and a flowchart illustrating an exemplary embodiment of a methodis provided in FIG. 13. Example 3 describes the exemplary method depicted in the flowchart of FIG. 13 in detail.

[0217] In embodiments, a method comprises opening a package. In embodiments, a method comprises opening a package by manually tearing the package open. In embodiments, a method comprises opening a package by manually tearing the package open with a tear notch in the package.

[0218] In embodiments, opening a package opens a pouch. In embodiments, opening a package comprises opening a reservoir pouch. In embodiments, opening a package comprises opening a pouch comprising a test strip. In embodiments, opening a package comprises opening a pouch comprising a scoop.

[0219] In embodiments, a method comprises adding a solvent into a pouch. In embodiments, a method comprises adding a solvent into a reservoir pouch. In embodiments, a method comprises adding water into a pouch. In embodiments, a method comprises adding water into a reservoir pouch.

[0220] In embodiments, a method comprises adding a drug sample into a pouch. In embodiments, a method comprises adding a drug sample into a pouch using a scoop. In embodiments, a method comprises adding a drug sample into a reservoir pouch. In embodiments, a method comprises adding a drug sample into a reservoir pouch using a scoop. In embodiments, where a method comprises adding a drug sample into a pouch (e.g., a reservoir pouch) using a scoop, the method comprises adding between about one and ten scoopfuls of the drug sample into the pouch. In embodiments, a method comprises adding between about one and eight scoopfuls of the drug sample into the pouch. In embodiments, a method comprises adding one, two, three, four, five, six, seven, or eight scoopfuls of a drug sample into a pouch.

[0221] In embodiments, a method comprises adding a solvent into a pouch before adding a drug sample into a pouch. In embodiments, a method comprises adding a drug sample into a pouch before adding a solvent into a pouch. In embodiments, adding a drug sample and a solvent into a pouch dissolves the drug in the solvent, resulting in a drug sample solution.

[0222] In embodiments, a method comprises mixing a drug sample. In embodiments, a method comprises mixing a drug sample before adding the drug sample into a pouch. In embodiments, a method comprises mixing a drug sample by crushing or otherwise reducing the particle size of the sample, optionally together with shaking, stirring, and / or using another applicable mixing method. In embodiments, mixing the drug sample reduces the chances of obtaining a false negative result, for example if the drug sample comprises a contaminant and the contaminant is unevenly distributed within the sample.

[0223] In embodiments, a drug sample is a solid. In embodiments, a drug sample is a liquid. In embodiments, a drug sample is a solution of a drug in a solvent. In embodiments, a drug sample is an aqueous solution of a drug.

[0224] In embodiments, where a method comprises adding a solvent into a pouch (e.g., a reservoir pouch), the solvent is added in a specified amount according to a measurement marking on the pouch. In embodiments, the solvent is added in a specified amount according to the amount of drug sample that hasbeen (or will be) added into the pouch. In embodiments, a method comprises adding between about 10 mL and 100 mL of solvent into a pouch. In embodiments, a method comprises adding between about 10 mL and 50 mL of solvent into a pouch. In embodiments, a method comprises adding between about 25 mL and 100 mL of solvent into a pouch. In embodiments, a method comprises adding between about 25 mL and 50 mL of solvent into a pouch. In embodiments, a method comprises adding about 25 mL, about 30 mL, about 35 mL, about 40 mL, about 45 mL, about 50 mL, about 55 mL, or about 60 mL of solvent into a pouch.

[0225] In embodiments, a method comprises adding a drug sample and a solvent into a pouch to achieve a specified ratio of drug to solvent. In embodiments where a method comprises adding one scoopful of a drug sample into a pouch, the method comprises adding about 25 mL of solvent into the pouch. In embodiments where a method comprises adding two scoopfuls of a drug sample into a pouch, the method comprises adding about 30 mL of solvent into the pouch. In embodiments where a method comprises adding three scoopfuls of a drug sample into a pouch, the method comprises adding about 35 mL of solvent into the pouch. In embodiments where a method comprises adding four scoopfuls of a drug sample into a pouch, the method comprises adding about 40 mL of solvent into the pouch. In embodiments where a method comprises adding five scoopfuls of a drug sample into a pouch, the method comprises adding about 45 mL of solvent into the pouch. In embodiments where a method comprises adding six scoopfuls of a drug sample into a pouch, the method comprises adding about 50 mL of solvent into the pouch. In embodiments where a method comprises adding seven scoopfuls of a drug sample into a pouch, the method comprises adding about 55 mL of solvent into the pouch. In embodiments where a method comprises adding eight scoopfuls of a drug sample into a pouch, the method comprises adding about 80 mL of solvent into the pouch.

[0226] In embodiments, a method comprises adding a drug sample and a solvent into a pouch to achieve a specified concentration of the drug sample in the solvent. In embodiments, a method comprises adding a drug sample and a solvent into a pouch to achieve a concentration of the drug sample in the solvent that is about 10 mg / mL (i.e., 10 mg drug sample per mL of solvent), about 9 mg / mL, about 8 mg / mL, about 7 mg / mL, about 6 mg / mL, about 5 mg / mL, about 4 mg / mL, about 3 mg / mL, about 2 mg / mL, or about 1 mg / mL, including values in between. In embodiments, a specified concentration of drug sample in a solvent may be referred to as the “dilution rate” for a package. In embodiments, the dilution rate is between about 1 mg / mL and about 10 mg / mL. In embodiments, the dilution rate is about 2 mg / mL.

[0227] In embodiments, a method comprises contacting a test strip with a drug sample solution (e.g., where the drug sample solution is in a pouch). In embodiments, a method comprises contacting a test strip with a drug sample solution for a specified amount of time, such as between about 30 seconds and 5 minutes. In embodiments, a method comprises contacting a test strip with a drug sample solution for about thirty seconds, about one minute, about two minutes, about three minutes, about four minutes, or about five minutes. In embodiments, a method comprises contacting a test strip with a drug sample solution for a time sufficient to allow any contaminants present in the drug sample to interact with a component of the test stripdesigned to detect the contaminant.

[0228] In embodiments, a method comprises resting a test strip after contacting the test strip with the drug sample solution. In embodiments, “resting” refers to placing the test strip in a stationary position, undisturbed, after it has been contacted with the drug sample solution, allowing sufficient time for a contaminant and a component of the test strip designed to detect a contaminant to interact. In embodiments, the test strip is rested on a flat surface. In embodiments, the surface is clean and dry. In embodiments, a method comprises resting a test strip for between about 1 minute and about 15 minutes. In embodiments, a method comprises resting a test strip for about 1 minute, about 2 minutes, about 3 minutes, about 4 minutes, about 5 minutes, about 10 minutes, or about 15 minutes.

[0229] In embodiments, a method comprises reading the test strip. In embodiments, reading the test strip determines the presence or absence of a contaminant. In embodiments, a test strip comprises a visual marking indicative of the presence of a contaminant. In embodiments, a test strip comprises a visual marking indicative of the absence of a contaminant. For example, a test strip designed to detect fentanyl will display a colored line if fentanyl is detected. In embodiments, reading the test strip comprises visually comparing the test strip with printed information on a package that describes the appearance of the test strip when a contaminant is detected or not detected.

[0230] In embodiments, users can cross-reference a test strip with the “Results” images to determine the presence or not of a contaminant, and therefore to provide a visual confirmation of the results (e.g., “T” for “Test” or positive; “C” for “Control” together with T, for negative; C alone or no marking for an invalid test).

[0231] Advantages of disclosed methods of drug checking, such as in comparison to prior art methods, include reduced chances of user error, ensuring confidence in the accuracy and reliability of the results.

[0232] In embodiments, a disclosed method has increased accuracy compared to a prior art method. In embodiments, “accuracy” refers to the proportion of total correct test results, representing the method’s effectiveness in correctly identifying both the presence and absence of contaminants. It is calculated by dividing the sum of true positives (cases where contaminants are correctly detected) and true negatives (cases where contaminants are correctly identified as absent) by the total number of tests, including any false positives (incorrect detection of contaminants) and false negatives (missed detection of contaminants).

[0233] In embodiments, a disclosed method has increased precision compared to a prior art method. In embodiments, “precision” refers to the proportion of positive test results that are correct, representing the method’s reliability in confirming contaminant presence when indicated. It is calculated by dividing the number of true positives (cases where contaminants are correctly detected) by the total number of positive results, including both true positives and false positives (incorrect detection of contaminants).

[0234] In embodiments, testing a drug sample according to a disclosed method has a reduced probability of obtaining a false positive result, compared to a prior art method. In embodiments, testing a drug sample according to a disclosed method has a reduced probability of obtaining a false negative result,compared to a prior art method.

[0235] In embodiments, testing a drug sample according to a disclosed method is non-destructive, i.e., allows a user to use the drug sample after testing. For example, a user may evaporate a drug sample solution using any suitable means, to obtain the drug sample in solid form, which may be used by the user. By comparison, certain prior art methods (such as chemical reagent testing) are destructive, i.e., render at least part of the drug sample unsuitable for consumption after testing.

[0236] Further advantages of disclosed methods over prior art methods will be apparent to one of skill.G. ExamplesEXAMPLE 1: Exemplary Integrated Single Use Test Kit Comprising Two Pouches

[0237] In some aspects are provided an integrated single use test kit (i.e., “package”) comprising two pouches, such as illustrated in FIGS. 1, 2, and 9. Exemplary package 100 comprises two pouches 106 and 107, a test strip 903, a scoop 905, and a desiccant 904.

[0238] The exemplary package comprises a front surface 101 and a back surface 201. The outer perimeter of the package is defined by two side sealed edges 102 and 103, a folded bottom edge 104, and a top sealed edge 105. The exemplary package has a height H1 (i.e. the distance between the folded bottom edge 104 and the top sealed edge 105) of 165 mm and a width W1 (i.e. the distance between the two side sealed edges 102 and 103) of 141.5 mm. The seal width H2 is 5 mm.

[0239] Pouches 106 and 107 are positioned side-by-side, and separably connected by a frangible connection 108 between the sealed side edges of the two pouches. The frangible connection 108 comprises a perforation line designed to allow the pouches to be manually separated by a user, such as by pulling the pouches apart from each other. Pouch 106 has a width W2 (i.e., the distance between the side sealed edge 102 and the frangible connection) of 100 mm and pouch 107 has a width W3 (i.e., the distance between the side sealed edge 103 and the frangible connection) of 41.5 mm. Pouch 106 contains a test strip, such as the exemplary fentanyl test strip depicted in FIG. 10. Pouch 106 also contains a desiccant, such as the desiccant packet 904. Pouch 107 contains a scoop 905 (such as the exemplary scoop depicted in FIG. 11) designed to have a capacity of about 10 mg.

[0240] Pouch 107 is a reservoir pouch structured to contain a solvent (e.g., water) and a drug sample. Pouch 107 comprises a transparent window through which a user can view the contents of the pouch, as shown in FIG. 2. Pouch 107 comprises measurement marks printed on the transparent windows to aid a user in filling the pouch with a solvent to a desired volume, as shown in FIG. 2.

[0241] As shown in FIG. 2, additional information is printed on the surface of the package, including instructions for use, instructions for interpreting test strip results, and a QR code leading to a website or app.

[0242] The exemplary package comprises tear notches 109 positioned below the top sealed edge. The distance between the top sealed edge and the tear notch H3 is 8 mm. The tear notch is structured to enable a user to remove the top sealed edge of the package, so as to open both pouches of the package with asingle manual motion, as well as to open each pouch individually, if preferred. Opening the pouches at the tear notch allows the user to access and remove the test kit components, and to use the reservoir.EXAMPLE 2: Exemplary Alternative Embodiment Comprising Three Pouches

[0243] In some aspects are provided an integrated single use test kit (i.e., “package”) comprising three pouches, such as illustrated in FIGS. 15 and 16. Exemplary package 1500 comprises three pouches 1501, 1502, and 1503, a test strip, a scoop, and a desiccant packet. The package has a height H1 (i.e. the distance between the folded bottom edge and the top sealed edge) of 165 mm and a width W4 (i.e. the distance between the two side sealed edges) of 183 mm. The seal width H2 is 5 mm.

[0244] Pouches 1501 and 1503 are positioned on either side of pouch 1502. Pouch 1501 is separably connected to pouch 1502 by a frangible connection 1504. Pouch 1503 is separably connected to pouch 1502 by a frangible connection 1505. Both frangible connections comprise perforation lines designed to allow the pouches to be manually separated by a user, such as by pulling the pouches apart from each other.

[0245] Pouch 1502 has a width W2 of 100 mm. Pouch 1502 contains a test strip (such as the exemplary fentanyl test strip depicted in FIG. 10), and a desiccant packet. Pouches 1501 and 1503 each have a width W3 of 41.5 mm. Pouch 1501 contains a scoop (such as the exemplary scoop depicted in FIG. 11). Pouch 1503 contains a paper instruction guide (“Guide Inside”).

[0246] Pouch 1501 is a reservoir pouch structured to contain a solvent (e.g., water) and a drug sample. Pouch 1501 has a transparent window through which a user can view the contents of the pouch, as shown in FIG. 16. Pouch 1501 comprises measurement marks printed on the transparent window to aid a user in filling the pouch with a solvent to a desired volume, as shown in FIG. 16.

[0247] As shown in FIG. 16, information is printed on the surface of the package, including instructions for use and for interpreting test strip results, and a QR code, such as leading to a website or for an app.

[0248] The exemplary package comprises tear notches positioned below the top sealed edge. The distance between the top sealed edge and the tear notch H3 is 8 mm. The tear notch is structured to enable a user to remove the top sealed edge of the package, so as to open all three pouches of the package with a single manual motion, or to open each of the pouches individually, as preferred. Opening the pouches at the tear notch allows the user to access and remove the test kit components, and to use the reservoir.EXAMPLE 3: Exemplary Method of Detecting a Contaminant Using a Disclosed Test Kit

[0249] In some aspects are provided methods of detecting a contaminant in a drug sample using disclosed test kits, such as the test kits and components thereof depicted in FIGS. 1-12 and FIGS. 15-16.

[0250] A flowchart describing a method according to one embodiment of the disclosure is shown in FIG. 13, which is described in detail below. While the method described below includes particular steps, it will be apparent that other methods of the disclosure including fewer, more, or different steps than those described below are also within the spirit and scope of the invention.

[0251] In this example, the method optionally comprises scanning a QR code (1301) printed on theexterior of the package. The QR code may lead a user to a website containing instructions for using the kit to detect a contaminant, surveys for customer feedback, advice, or other relevant information. The QR code may also lead a user to a website where results can be recorded and feedback related to recorded results can be communicated to the user. Although shown in FIG. 13 as an exemplary first step, it will be understood that this step can be conducted at any other step of the method, including as a last step. Instructions for use can be printed on an exterior surface of the test kit or on a pamphlet or other material. The method comprises opening the package (1302). In embodiments, opening the package opens one or more pouches of the package. In embodiments, opening the package opens both pouches of the package. In embodiments, the package is opened by manually tearing the package open along the top side edge of the package, using the tear notches of the package. Opening the test kit provides access to the reservoir, scoop, and the test strip.

[0252] The method further comprises mixing the drug sample (1303). In embodiments, mixing the drug sample reduces the chances of obtaining a false negative result, for example if the drug sample comprises a contaminant and the contaminant is unevenly distributed within the sample. The drug sample may be mixed by crushing or otherwise reducing the particle size of the sample, optionally together with shaking, stirring, and / or using another applicable mixing method. The method further comprises either: (1) filling the reservoir pouch with a specified quantity of solvent (1304), then adding a portion of the drug sample to the reservoir pouch (1305); or (1) adding a portion of the drug sample to the reservoir pouch (1305), then filling the reservoir pouch with a specified quantity of solvent (1304). The drug sample is added to the reservoir pouch using a scoop, such as the exemplary scoop depicted in FIG. 11.

[0253] In embodiments, the solvent filled into the reservoir pouch is water. The solvent may be added in a specified amount to achieve a target ratio of drug to solvent. In embodiments where one scoopful of the drug sample is added into the pouch, about 25 mL of solvent is added into the pouch. In embodiments where two scoopfuls of the drug sample are added into the pouch, about 30 mL of solvent is added into the pouch. In embodiments where three scoopfuls of the drug sample are added into the pouch, about 35 mL of solvent is added into the pouch. In embodiments where four scoopfuls of the drug sample are added into the pouch, about 40 mL of solvent is added into the pouch. In embodiments where five scoopfuls of the drug sample are added into the pouch, about 45 mL of solvent is added into the pouch. In embodiments where six scoopfuls of the drug sample are added into the pouch, about 50 mL of solvent is added into the pouch. In embodiments where seven scoopfuls of the drug sample are added into a pouch, about 55 mL of solvent is added into the pouch. In embodiments where eight scoopfuls of the drug sample are added into into pouch, about 80 mL of solvent is added into the pouch.

[0254] The method further comprises contacting a test strip with a drug sample solution (e.g., dipping the testing strip into the solution) (1306). In embodiments, the test strip comprises a lateral flow immunoassay. The test strip may have markings indicating the maximum depth the test strip should be inserted into the solution. The test strip is contacted with the drug sample solution for an amount of timesufficient to allow any contaminants present in the drug sample to interact with the test strip (e.g., any component of the test strip designed to detect a contaminant). For example, the test strip may be contacted with the solution for about ten seconds.

[0255] The method further comprises resting the test strip (1307), by placing the test strip in a stationary position, undisturbed, after it has been contacted with the drug sample solution, allowing sufficient time for a contaminant and a component of the test strip designed to detect a contaminant to interact. In embodiments, the test strip is rested on a flat surface. In embodiments, the test strip is rested for about three to five minutes. Lastly, the method comprises reading the test strip (1307). In embodiments, the test strip comprises a visual marking indicative of the presence of a contaminant. In embodiments, the test strip comprises a visual marking indicative of the absence of a contaminant. In one example, a test strip designed to detect fentanyl displays a colored line if fentanyl is detected in the drug sample. If the drug sample does not contain a contaminant, the control line and negative test line will provide a visual cue, such as a color on the respective lines. The method may optionally comprise evaporating the solution containing the drug sample and the solvent (1309). A user may evaporate a drug sample solution using any suitable means, to retrieve the drug sample in solid form (1310). The drug sample may then be extracted for future testing or other use.H. Exemplary Aspects and Embodiments

[0256] Among the various exemplary and non-limiting aspects and embodiments are the following.

[0257] In some exemplary aspects are disclosed integrated single use test kits for detecting a contaminant in a sample, comprising a reservoir, a scoop, and a test strip.

[0258] In embodiments, the reservoir is designed to contain the scoop before use. In embodiments, the reservoir is designed to contain the sample and a solvent during use. In embodiments, the reservoir has a total capacity of between about 25 mL and about 100 mL. In embodiments, the reservoir has a total capacity of about 74 mL. In embodiments, the reservoir is designed to contain the sample and a solvent in a concentration of from about 1 mg / mL to about 10 mg / mL. In embodiments, the reservoir is designed to contain the sample and a solvent in a concentration of about 2 mg / mL.

[0259] In embodiments, the reservoir comprises a substantially transparent portion. In embodiments, the substantially transparent portion allows a user to determine the level of solvent in the reservoir.

[0260] In embodiments, the reservoir comprises an interior back surface comprising a metallic foil material. In embodiments, the metallic foil material allows a user to more easily determine the level of solvent in the reservoir. In embodiments, the reservoir contains the scoop. In embodiments, the scoop has a capacity of about 0.01 mL. In embodiments, the scoop has a capacity of about 10 mg.

[0261] In embodiments, a disclosed test kit comprises two subunits. In embodiments, the first subunit comprises the reservoir, and a second subunit comprises a pouch containing the test strip.

[0262] In embodiments, the subunits are sealed until the test kit is ready to be used. In embodiments, the subunits are adapted to be manually unsealed before use. In embodiments, the subunits are separablefrom each other. In embodiments, the subunits are adapted to be manually separated from each other.

[0263] In embodiments, the contaminant is a contaminant in a drug sample. In embodiments, the contaminant is an opioid, a benzodiazepine, xylazine, another drug substance, or a non-drug substance.

[0264] In embodiments, the contaminant is an opioid. In embodiments, the opioid is fentanyl, phenyl fentanyl, 4-methoxy-butyryl fentanyl, 4-fluoro-butyr fentanyl, acetyl fentanyl, methoxyacetyl fentanyl, acetyl fentanyl, methoxyacetyl fentanyl, acryl fentanyl, desmethyl fentanyl, methoxyacetyl fentanyl, N-methyl norfentanyl, 4-fluoro isobutyryl fentanyl, cyclopropyl fentanyl, THF-fentanyl, 3-furanyl fentanyl, furanyl fentanyl, 3-methyl butyrfentanyl, 4-fluoro isobutyryl fentanyl, ocfentanil, 4-fluoro cyclopropyl benzyl fentanyl, p-fluoro 4-ANBP, carfentanil, N-benzyl furanyl norfentanyl, MT-45, or 4-ANPP.

[0265] In embodiments, the contaminant is a benzodiazepine. In embodiments, the benzodiazepine is alprazolam, bromazepam, chlordiazepoxide, clobazam, clonazepam, clorazepate, diazepam, estazolam, etizolam, flunitrazepam, flurazepam, flutoprazepam, halazepam, ketazolam, loprazolam, lorazepam, lormetazepam, midazolam, nimetazepam, nitrazepam, oxazepam, prazepam, quazepam, temazepam, tetrazepam, or triazolam. In embodiments, the contaminant is xylazine.

[0266] In embodiments, a disclosed test kit further comprises instructions for use on an exterior surface. In embodiments, a disclosed test kit further comprises a QR code on an exterior surface.

[0267] In some further exemplary aspects are disclosed methods of using the integrated single use test kit of any of the disclosed embodiments.

[0268] While the methods described herein may include particular steps, it will be apparent that other methods including fewer, more, or different steps than those described are also within the spirit and scope of the invention. The methods and uses of any test kit discussed and associated steps shown herein therefore should be understood as being provided for purposes of illustration, not limitation, and the specific order of steps in the methods are only exemplary. All disclosed methods can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context.

[0269] The foregoing description, for purposes of explanation, uses specific nomenclature to provide a thorough understanding of the invention. However, it will be apparent to one in the art that specific details may not be required to practice the invention. The foregoing description, and the disclosed specific embodiments, are exemplary and presented for purposes of illustration. They are not exhaustive, and should not be read to limit the invention to any of the precise forms disclosed, as many modifications and variations are possible and will be appreciated in view of the above teachings. The disclosed embodiments were chosen to best explain the principles of the invention and its practical applications, and are specific examples to enable others in the art to best utilize the invention and its various embodiments, including with further modifications that are suited to a particular use contemplated, including for uses that are beyond the specific examples disclosed. The scope of the invention shall be defined solely by the claims and their equivalents.

Claims

CLAIMSThe invention claimed is:

1. An integrated single use test kit for detecting a contaminant in a sample, comprising packaging material structured to form a plurality of pouches, wherein: a. a first pouch is structured to form a reservoir for holding a volume of a solvent; b. the first pouch contains a scoop designed to measure a quantity of the sample; c. a second pouch contains a test strip designed to detect the contaminant; d. the first pouch and the second pouch are separably connected; and e. the first pouch and the second pouch are designed to remain closed until opened for use.

2. The test kit of claim 1 , wherein the packaging material comprises a thermoplastic polymer.

3. The test kit of claim 1 , wherein the first pouch is structured to form a reservoir having a capacity of between about 25 mL and about 100 mL.

4. The test kit of claim 3, wherein the first pouch is structured to form a reservoir having a capacity of about 74 mL.

5. The test kit of claim 1 , wherein the first pouch comprises a transparent or translucent window.

6. The test kit of claim 5, wherein the transparent or translucent window comprises measurement marks.

7. The test kit of claim 1 , wherein an interior surface of the first pouch comprises a metallic foil material.

8. The test kit of claim 1 , wherein the scoop has a capacity of about 0.01 mL.

9. The test kit of claim 1 , wherein the scoop has a capacity of about 10 mg.

10. The test kit of claim 1 , wherein the test strip is a lateral flow assay test strip.11 . The test kit of claim 1 , wherein the test strip is a lateral flow immunoassay test strip.

12. The test kit of claim 1 , wherein the test strip is designed to detect a contaminant in a drug sample.

13. The test kit of claim 1 , wherein the test strip is designed to detect fentanyl, a benzodiazepine, or xylazine.

14. The test kit of claim 1 , wherein the test strip is a fentanyl test strip.

15. The test kit of claim 1 , wherein the test strip is designed to detect a non-drug compound.

16. The test kit of claim 1 , wherein the first pouch and the second pouch are separably connected alongthe length of a right side edge or a left side edge of the first pouch and the second pouch.

17. The test kit of claim 1, wherein the first pouch and the second pouch are separably connected with a frangible connection.

18. The test kit of claim 17, wherein the frangible connection is structured to allow the pouches to be separated with minimal manual force.

19. The test kit of claim 1 , wherein the first pouch and the second pouch are designed to remain closed until opened by tearing along the top side edge.

20. The test kit of claim 19, wherein the first pouch and the second pouch comprise tear notches to enable opening by tearing along the top side edge.21 . The test kit of claim 1 , wherein the exterior surface of the material comprises a QR code.

22. The test kit of claim 1 , wherein the exterior surface of the material comprises instructions for use.

23. The test kit of claim 1 , further comprising a third pouch.

24. The test kit of claim 23, wherein the third pouch contains a printed guide.

25. The test kit of claim 1 , wherein the overall dimensions of the test kit are less than 20 cm by 20 cm.

26. The test kit of claim 25, wherein the overall dimensions of the test kit are about 15 cm by about 16 cm.

27. The test kit of claim 1 , wherein a single sheet of material is structured to form the plurality of pouches.

28. The test kit of claim 27, wherein the plurality of pouches is formed solely from the single sheet.

29. A method of manufacturing the test kit of claim 28, comprising: a. folding the single sheet of material to form a bottom edge; b. sealing the single sheet of material to form a sealed right side edge and a sealed left side edge; c. creating at least one separable connection between the right side edge and the left side edge, wherein the separable connection is sealed along both sides of the connection thereby forming at least two pouches; d. placing a test strip into a first pouch, and a scoop into a second pouch; e. sealing the top side edge of each of the plurality of pouches to close the pouches; and f. forming tear notches in each of the plurality of pouches to enable each of the plurality of pouches to be opened for use.

30. A method of using the test kit of any of claims 1 -28, according to the steps of Figure 13.

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