Systems and methods for collecting and testing fluid samples - Patents.com

Abstract

The fluid sample testing device has a housing with a testing chamber and at least a first fluid collector in fluid communication with at least a first fluid collection tube and the testing chamber. The sample holding container is in fluid communication with the fluid collection tube. The fluid collector is inserted into the fluid collection tube, and pressure is generated to expel fluid from the fluid collector into the testing chamber. The gasket, when placed in the fluid collection tube, allows air to pass to the outside of the device at the upper portion, and the gasket forms a seal with the testing chamber when positioned in the lower portion.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to Provisional Application No. 62 / 970,663, filed February 5, 2020, and Provisional Application No. 16 / 792,175, filed February 14, 2020, both of which share the same assignee as this application, and which are incorporated herein by reference.

[0002] The present invention relates to the collection and testing of materials, particularly fluid samples, and more particularly to a device for testing a fluid sample for the presence or absence of at least one analyte, preferably (but optionally) with improved fluid and air flow characteristics, while retaining the fluid sample separately for later confirmation, or preferably (but optionally) providing positive identification of the individual associated with the sample. "Double swab" embodiments referred to herein may be referred to herein as "double swab devices." Embodiments of the present application having only a "single swab" may be referred to herein as "single swab devices." Both double swab and single swab devices are within the scope of the present invention and, as described below, preferably include a lateral flow assay strip within the test strip chamber, and may also preferably have a double or single test strip cassette within the test strip chamber. [Background technology]

[0003] Reference is made to co-pending U.S. patent applications Ser. Nos. 15 / 417,905 and 15 / 418,044 (the "Referenced Patent Documents"), which are incorporated herein by reference (but see in particular Figures 19-25 and related descriptions of Ser. No. 15 / 418,044, and Ser. No. 15 / 417,905 in its entirety).

[0004] Testing for drugs and other analytes has become ubiquitous in modern society. There is a need for effective, inexpensive, and reliable testing devices in homes, hospitals, police vehicles and stations, athletic facilities, and workplaces. There is also a growing need for devices to test body fluids for substances to aid in the diagnosis or management of disease and other medical conditions.

[0005] The market has responded, and many devices are now available for testing blood, urine, or saliva. However, these devices may require sequential testing, involving transferring the fluid sample under test to different containers and / or transporting the fluid sample to a remote location. These devices may also require test administrators to handle the subject's bodily fluids, creating a risk of disease exposure.

[0006] Once an initial test result is obtained, the same fluid sample is often further tested to confirm or refine the initial test result. In the case of membrane test strip devices, the fluid sample may not even be retained once the initial test result is obtained, making it necessary to retain aliquots. The need to retain aliquots introduces the risk of the sample being lost, mislabeled, or contaminated.

[0007] The chain of custody associated with test samples often creates doubt about the results because fluid samples can be contaminated, misplaced, or mistaken for another fluid sample entirely. In many cases, the identity of the subject associated with a fluid sample is important for proper processing of the results.

[0008] Prior art testing devices include those disclosed in U.S. Patent Nos. 7,879,623 and 8,940,527, both of which are entitled "Integrated Device for Analyte Testing, Confirmation, and Donor Identity Verification," and each of which lists Rao A. Girgais as the sole inventor. Both U.S. Patent Nos. 7,879,623 and 8,940,527 are incorporated herein by reference. These patents disclose devices for fluid sample collection and analyte testing, including a single sample receiving member and at least one membrane test strip, and optionally a sample retaining member, fingerprint acquisition pad, and / or fluid collector. They also provide fluid collection devices having an absorbent material, a compression element, and a closure element, and optionally a lid to enable the device to be used in conjunction with a fluid container. Also provided is a method for collecting, testing, and holding a fluid sample and verifying the identity of one or more individuals associated with the sample, such as a subject, a test administrator, and / or a witness, wherein the components for collecting, testing, and holding the fluid sample are in fluid communication with other components of the testing device.

[0009] There is also a growing need for devices directed to testing for contaminants that may be found in food and water, such as contaminants, allergens, and harmful microorganisms. In some cases, it is desirable to retain a fluid sample for confirmatory testing or further analysis, to retain an aliquot fluid sample of the original sample for confirmatory testing or further analysis, or to provide positive identification of the test administrator.

[0010] The U.S. Department of Transportation (DOT) Code of Federal Regulations, 49 C.F.R., Part 40, establishes procedures for in-house drug and alcohol testing for federally regulated transportation industries. Within this regulation, definitions of split samples and split sample collection are provided. A split sample (test sample) is defined for drug testing as a portion of a urine specimen sent to a primary laboratory and retained unopened, which is sent to a secondary laboratory upon an employee's request for testing after the primary sample has tested positive or has been verified as adulterated or substituted. A split sample collection is defined as a collection in which the collected urine is divided into two separate specimen bottles: a primary sample (Bottle A) and a split sample (Bottle B).

[0011] Thus, there is a need in the industry to combine, in a single device, the simplicity of current membrane test strip technology with the ability to positively identify the subject and / or test administrator, and the ability to retain an aliquot portion of the fluid sample in a single device for later identification.

[0012] There is also a need in the industry for such devices to reduce the "squeezing pressure" required to lock a swab or swabs into the device, facilitating actuation by users of varying strengths. There is also a need for improved test strip carriers for test strip testing of substances that tend to bind or adhere to various surfaces, such as THC.

[0013] The disclosures of US Pat. Nos. 9,414,813 and 10,035,146 are also incorporated herein by reference. Summary of the Invention

[0014] According to certain preferred embodiments of the present invention, a fluid sample testing device includes: a housing with a testing chamber and a first fluid collection tube of a first diameter and a second fluid collection tube of a second diameter, the testing chamber being in fluid communication with the first fluid collection tube; a sample holding container in fluid communication with the second fluid collection tube; and first and second fluid collectors, the first fluid collector configured to be inserted into the first fluid collection tube, wherein, when inserted into the first fluid collection tube, pressure is generated to draw fluid into the testing chamber. and a second fluid collector configured to be inserted into the second fluid collection tube simultaneously with the insertion of the first fluid collector into the first fluid collection tube, such that upon insertion into the second fluid collection tube, pressure is generated to eject fluid from the second fluid collector into the sample holding container and air is passed from the second fluid collection tube to the exterior of the device.

[0015] The device may include a first fluid collector with an upper seal portion that, when substantially fully inserted into the first fluid collection tube, seals the opening between the test chamber and the swab tube of the first fluid collector. The device may include a second fluid collection tube with a shoulder adjacent the sample holding container and having a diameter smaller than the second diameter, where the second fluid collector has a lower seal portion that, when substantially fully inserted into the second fluid collection tube, seals the sample holding container from the upper portion of the second fluid collection tube. The first and second fluid collectors may include individual single swabs joined together by locked caps. The second diameter is preferably larger than the first diameter. The test chamber preferably has an upper end cap that is airtightly and watertightly sealed, preferably by ultrasonic welding, from the outside of the device and connected to the housing.

[0016]

[0006] Embodiments of the present invention further include a cassette for holding one or more test strips, wherein the cassette includes one or more channels for holding one or more test strips and at least a first channel for holding a first strip, the first channel having a plurality of protrusions from each of two opposing side walls of the first channel, the plurality of protrusions defining a central position at which the first strip is positioned, the plurality of protrusions positioning the first strip to reduce or prevent contact between the first strip and the side walls of the first channel, the first channel also having a floor with a plurality of raised portions, the plurality of raised portions positioning the first strip to reduce or prevent contact between the first strip and the floor of the first channel. In certain embodiments, the cassette has a front surface with the protrusions and also has side legs that are tapered or have a smaller dimension at a bottom portion compared to a larger dimension at an upper portion.

[0017] An embodiment of the present invention also includes a fluid sample testing device having a housing with a test chamber and a first fluid collection tube of a first diameter and a second fluid collection tube of a second diameter, the test chamber in fluid communication with the first fluid collection tube; a sample holding container in fluid communication with the second fluid collection tube; and first and second fluid collectors, the first fluid collector configured to be inserted into the first fluid collection tube such that, upon insertion into the first fluid collection tube, pressure is generated causing fluid to be expelled from the first fluid collector into the test chamber through an opening between the test chamber and the first fluid collection tube, air to pass from the test chamber to the exterior of the device through an opening from the test chamber to the first fluid collection tube, and the second fluid collector configured to collect the second fluid upon insertion of the first fluid collector into the first fluid collection tube. and a gasket positioned on the second fluid collection tube, the gasket having an upper portion that engages with a wall of the second fluid collection tube and a lower portion with a smaller diameter than the upper portion for insertion into the opening of the sample holding container, the gasket being in an upper position within the second fluid collection tube upon insertion of the second fluid collection tube, and the gasket being positioned in a lower position within the second fluid collection tube after insertion of the second fluid collection tube, the gasket forming a seal with the sample holding container in the lower position, and air passing from the second fluid collection tube to the outside of the device before the gasket is positioned in the lower position.

[0018] The first fluid collector may have an upper seal portion that, when substantially fully inserted into the first fluid collection tube, seals the opening between the test chamber and the swab tube of the first fluid collector. The device may include a first fluid collector having a lower seal portion configured to form a sliding seal between the lower seal portion and a surface wall of the first fluid collection tube as the first fluid collector is inserted into the first fluid collection tube. The upper seal portion may be configured to form a static seal for the opening between the test chamber and the first fluid collection tube and has a different shape than the lower seal portion. The upper seal portion may form a stopper seal for the opening between the test chamber and the first fluid collection tube, and the lower seal portion may form a syringe plunger seal between the lower seal portion and a surface wall of the first fluid collection tube. To form the syringe plunger seal, the lower seal portion may be formed with a plurality of spaced O-ring portions. The lower sealing portion may be formed with a textured surface to form a syringe plunger seal.

[0019] It is therefore an object of the present invention to provide single-swab and double-swab fluid collection and testing devices with improved air vent / air flow characteristics for improving the transfer of fluid through the channel into the testing chamber and, optionally, into a confirmation vial.

[0020] Another object of the present invention is to provide single and double swab fluid collection and testing devices that provide an improved user experience by reducing back pressure when the swab assembly is inserted therein and compressed downward, preferably in the locked position.

[0021] It is yet another object of the present invention to provide a swab assembly having a stopper-type upper seal and a syringe-type lower seal.

[0022] It is a further object of the present invention to provide a fluid collection device having a funnel-shaped gasket in a first position in which the swab may be initially compressed, and which upon increasing pressure may move to a second position in which the gasket seals the housing and vial, and prior to reaching the second position, air may be vented from the device to the outside.

[0023] Finally, it is an object of the present invention to provide a strip holding cassette for use in testing fluid samples, which has one or more channels with side protrusions and floor projections for positioning the strip, thereby reducing or preventing contact of the strip with the side walls of the channel or the floor of the channel. [Brief explanation of the drawings]

[0024] The above objects and other advantages of the present invention will become more apparent from the detailed description of preferred embodiments of the present invention with reference to the accompanying drawings, in which:

[0025] 1 to 3 show an overall device view of a fluid sample collection and testing device according to certain preferred embodiments of the present invention;

[0026] FIG. 4 illustrates fluid communication between the swab tube and the test chamber and between the swab tube and the confirmatory vial according to certain preferred embodiments of the present invention;

[0027] 5A and 5B show a top end cap, preferably ultrasonically weldable, according to certain preferred embodiments of the present invention;

[0028] 6A-6C illustrate a swab stem and swab assembly according to certain preferred embodiments of the present invention;

[0029] FIG. 7 illustrates a double swab stem handle for connecting two swab assemblies to create a double swab assembly, according to certain preferred embodiments of the present invention;

[0030] FIG. 8 illustrates a double swab assembly in accordance with certain preferred embodiments of the present invention;

[0031] 9-10 show general device views of a fluid sample collection and testing device according to certain additional preferred embodiments of the present invention;

[0032] 11A and 11B show a top end cap, preferably ultrasonically weldable, according to certain additional preferred embodiments of the present invention;

[0033] FIG. 12 illustrates a double swab stem handle and top end cap therefor for connecting two swab assemblies to create a double swab assembly, according to certain additional preferred embodiments of the present invention;

[0034] FIG. 13 illustrates a lockable bottom cap for a fluid sample collection and testing device, according to certain additional preferred embodiments of the present invention;

[0035] 14 and 15 show a vial verification stem tube venting means for a fluid sample collection and testing device, according to certain preferred embodiments of the present invention;

[0036] 16A-16D illustrate certain floor features and other attributes of a testing chamber and ventable / sealable gasket for a fluid sample collection and testing device, according to certain preferred embodiments of the present invention;

[0037] FIG. 17 illustrates an improved cassette for holding test strips for a fluid sample collection and testing device, in accordance with certain preferred embodiments of the present invention;

[0038] 18A-18B illustrate a ventable / sealable gasket for a fluid sample collection and testing device, in accordance with certain preferred embodiments of the present invention; and

[0039] FIG. 19 illustrates a swab assembly-housing retaining clip for a fluid sample collection and testing device, according to certain preferred embodiments of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0040] The present invention will be described in detail with reference to certain preferred and alternative embodiments. As will be explained below, various modifications and substitutions of the embodiments are possible based on the principles and teachings of the present application.

[0041] As will be appreciated from the patent documents referenced above, and particularly in light of the present disclosure, the present invention utilizes a fluid (e.g., saliva) absorption or capture device (herein referred to as a "swab" or a sponge / spongy material that may absorb / accommodate and release a liquid of interest), which preferably captures oral fluid, such as by inserting the swab into a subject's mouth, whereby the oral fluid is captured / absorbed by the swab (it will be understood that when the term "saliva" is used, materials other than oral fluid may also be used in accordance with embodiments of the present invention). As an illustrative example, in accordance with alternative embodiments of the present invention, the swab may be moistened with water or other fluids, such as alcohol, and then contacted with a dry powder or other substance (which may be a suspected drug, contaminant, or other material of interest or concern), and the swab is inserted into the device for testing. Each swab is preferably mounted on a stem-type device, allowing the stem to be held like a lollipop, allowing the absorbent material of the swab / sponge to be easily positioned in the subject's mouth. After a sufficient length of time, e.g., 2-5 minutes, and preferably as indicated by an indicator means (described below), saliva is typically captured in a sufficient amount for introduction via the double swab into the housing of the double swab device for testing and preferably confirmation (described in more detail below). In the alternative single swab device, saliva is typically captured in a sufficient amount for introduction via the single swab into the housing of the single swab device for testing (described in more detail below). In both single and double swab devices, inserting the swab into the housing using the stem preferably causes compression of the swab into the bottom of the swab tube within the housing, forcing the saliva out of the swab, where pressure is generated to push or extrude the saliva from the swab tube into the lateral flow assay strip chamber through an opening sized for the particular fluid under test (there is fluid communication from the swab tube into the strip chamber via a channel within the housing).Saliva contacts the strip, which may detect a drug history, disease, or other substance at a desired level (see referenced patent documents). In double-swab devices, a second swab tube is provided, so that the second swab is compressed to release saliva, which may be captured in a vial separate from the chamber containing the assay strip. When the double swab is fully inserted, the unit is sealed to minimize fluid leakage from the device. In double-swab devices, a relatively quick initial screening may be performed via the assay strip, and a second sample may be captured in a vial separate from and not in fluid communication with the chamber containing the strip, which may be available for confirmatory testing in a laboratory, for example, for complex analysis via mass spectrometry, such as liquid chromatography-mass spectrometry (LC-MS). In single-swab devices, no confirmatory vial is provided, and preferably only screening via the assay strip is provided.

[0042] 1 and 2, an assembled double swab device 1 is shown. A housing 2 (preferably a plastic or similar material such as polycarbonate PC or general purpose polystyrene GPPS) provides the body of the unit. In the illustrated test chamber, a strip card / carrier or cassette 3 is provided, which contains one or more assay strips, generally designated 7. In use, fluid is introduced into the test chamber 2C of the housing 2, and based on predetermined characteristics of the one or more strips 7, the presence or absence of one or more target analytes (e.g., drugs, disease markers, etc.) may be detected. The test chamber 2C of the housing 2 has an upper body plug or top end cap 4, which is preferably ultrasonically welded to the housing 2 to provide an air-tight and water-tight seal, the ultrasonic welding being performed after the cassette 3 is inserted into the test chamber 2C. As shown, the double swab device preferably includes two swab assemblies, preferably connected via interlocking locking caps or double stem handles 8 (each swab assembly is inserted into stem handle 8, each having a locking mechanism for engaging a corresponding mechanism on stem handle 8, locking both together to create the double swab assembly).Each of the swab assemblies 5A and 5B generally comprises the following elements: stems 6A and 6B (preferably made of plastic as described for housing 2) having at least a viewing window (shown as an oval in FIG. 1) so that a color change in an indicator strip inside stems 6A and 6B is visible to an observer (and possibly the subject) (the indicator strip is described in more detail below, and that description is also applicable here); providing seals 9A and 9B in the upper portion of the swab assembly (such as by "two shot" or "overmolding") and seals 11A and 11B in the lower portion of the swab assembly. swabs 12A and 12B (absorbent or sponge-like material as described elsewhere herein), preferably secured by adhesive or other attachment means, secured to the bottom of stems 6A and 6B to provide saliva capture means for the device (shown in a compressed configuration in FIG. 1); tooth rests 10A and 10B, preferably made of a material similar to seals 9A, 9B, 11A, and 11B, and preferably positioned to provide a comfortable and desirable resting place for the subject's anterior teeth (this allows the swab stems to be more comfortably held in a manner that more ideally captures oral fluids, etc.). Vial 15 is provided in the double swab device so that a confirmatory sample may be obtained. Vial 15 is preferably secured to housing 2 via threads 14 or other securing mechanism on housing 2 and is preferably sealed with O-ring 16. As will be understood based on the description herein, swab assembly 5A may be compressed within tube 2A of housing 2 (see FIG. 3) to expel oral fluid through fluid channel 2D into vial 15 (vial 15 is in fluid communication with tube 2A as shown), and swab assembly 5B may be compressed within tube 2B of housing 2 to expel oral fluid through channel 23 into test chamber 2C (see FIG. 4) (test chamber 2C is in fluid communication with tube 2B as shown)

[0043] FIG. 3 illustrates additional features of a preferred embodiment of the present invention in cross section. Focusing first on the leftmost swab assembly 5B and swab tube 2B (sometimes referred to herein as the "strip swab tube") of housing 2, strip swab assembly 5B is shown in cross section fully inserted into the strip swab tube (with swab 12B compressed). Swab tube 2B preferably has a first diameter dimension, and seal 11B is sized to form a relatively tight fit / seal with swab tube 2B. When strip swab assembly 5B is inserted into swab tube 2B, this relatively tight fit / seal causes compression of swab 12B (and release of saliva from the swab), resulting in internal pressure in the lower portion of swab tube 2B, which in turn releases saliva from swab 12B and forces or pressure-moves saliva into test chamber 2C of housing 2 through an opening (see opening or saliva passageway 23 in FIG. 4). The size of this opening is preferably determined based on the characteristics of the particular fluid being tested, such as its viscosity. Importantly, the relatively tight fit / seal of the swab assembly 5B and the diameter of the swab tube 2B and seal 11B are such that a plunger / compression effect is achieved, forcing saliva out and into the test chamber 2C through the opening / passageway 23. Because internal pressure can build up within the test chamber 2C of the housing 2, in a preferred embodiment, air is vented from the test chamber 2C to the test swab tube 2B through a vent opening (see opening / vent 20 in FIG. 3, which provides fluid communication for the air vent between the test chamber 2C and the swab tube 2B). Note that there is no seal at the top of the swab tube 2B while the swab assembly 5B is inserted (the stem 6B of the swab assembly 5B is smaller in cross section than the internal dimensions of the swab tube 2B).Thus, during insertion, pressure from the compressed swab forces saliva into test chamber 2C, and air may be vented from test chamber 2C through opening / vent 20 into swab tube 2B and out the top, thereby reducing the "back pressure" experienced by a user pushing swab assemblies 5A and 5B into housing 2. However, once swab assembly 5B is fully inserted into swab tube 2B (and preferably locked by a locking tab or the like - see FIG. 7 and double-stem handle 8 and locking tab 8A, it will be understood that these engage with recesses or holes in the upper portion of the tube section of housing 2 to provide the locking mechanism), seal 9B seals or hermetically seals swab assembly 5B to swab tube 2B and also seals opening / vent 20. Thus, optionally, opening / vent 20 allows air to be released during the insertion process (preventing pressure from building up in the test chamber as saliva is forced in) and is then preferably closed by an overmolded seal once the swab tube assembly is fully inserted.

[0044] The rightmost swab tube 2A of housing 2 (sometimes referred to herein as the "verifier swab tube") operatively receives swab assembly 5A. Swab tube 5A has a second dimension (shown as 2E, preferably extending to the bottom as shown), and seal 11A has a diameter such that it forms a relatively loose fit / seal with swab tube 5A (and is substantially liquid-tight, though not airtight). Thus, when swab assembly 5A is inserted into swab tube 2A, swab 12A is compressed, expelling saliva into vial 15 through fluid channel 2D, while air may be evacuated around lower seal 11A and out through the top of swab tube 2A. The swab tube 2A preferably has a shoulder (generally designated 2F, a smaller diameter in a third dimension smaller than the second dimension) at its lower portion, such that when the swab assembly 5A is fully inserted into the swab tube 2A (see seal 11A in FIG. 4, showing engagement of seal 11A with the shoulder (2F) of the swab tube 2A), the seal 11A may tightly engage the shoulder (2F) to seal the vial 15 from the rest of the unit. FIG. 4 also illustratively shows a seal between the vial 15 and the housing 2 (see O-ring seal 16 in FIG. 4), securing the vial 15 to the housing 2, such as by a threaded mechanism (see threads 26 on the vial in FIG. 4, which engage corresponding threads 14 on the housing 2). Importantly, while swab assemblies 5A and 5B are preferably the same size, the diameters of swab tube 2B and swab tube 2A are different dimensions, creating pressure to force saliva into test chamber 2D (and thus evacuating air from test chamber 2D through opening / vent 20 into swab tube 2B) and air from confirmatory swab tube 2A out the top of confirmatory swab tube 2A. In an exemplary preferred embodiment, the third dimension is smaller than the first and second dimensions.

[0045] 5A and 5B illustratively show the body top cap 4, which is sealed to the top of the testing chamber of the housing 2, preferably by ultrasonic welding, to create an air-tight and water-tight seal. The body top cap 4 preferably has an energy director (guide) 4A to facilitate the ultrasonic welding process.

[0046] Figures 6A-6C illustratively show swab assembly 5A at various stages of manufacture. It will be understood that Figure 6A is after the first shot, i.e., first injection molding, of the plastic portion of swab assembly 5A (stem 6A is illustrated). It will be understood that Figure 6B is after the second shot, i.e., second injection molding, of the softer, more pliable material preferably used for seals 11A and 11B and tooth sets 10A and 10B, as described elsewhere herein. Figure 6C illustratively shows swab assembly 5A in cross section, allowing indicator strip 27 to be visible. In a preferred embodiment, swab assembly 5A (and preferably 5B) has an interior portion with an opening (preferably a slit) so that indicator strip 27 may be positioned to engage swab 12A at one end (shown as contact point 27A) and then extend within stem 6A to be visible through an oval window in stem 6A. As will be appreciated, indicator strip 27 is calibrated / configured to change color when wetted or saturated and act as an indicator that a substantial, and preferably sufficient, amount of saliva has been captured on swabs 12A and 12B, such that upon insertion of swab assembly 5A and 5B (1), strip 7 is activated to provide rapid screening for target substances / analytes, etc., and saliva is captured in vial 15 for later laboratory / confirmatory testing, if necessary or desired. Preferably, indicator strip 27 is visible to an observer and / or subject and provides a reliable indication that sufficient saliva has been captured prior to inserting swab assemblies 5A and 5B into housing 2.

[0047] As will be appreciated, the present invention encompasses both single-swab and double (dual) swab devices. In a single-swab device, the swab tube 2A, swab assembly 5A, vial 15, etc. are not included, and thus the housing 2 may be smaller (and may not, for example, include a lower skirt portion that surrounds and protects the vial 15). However, in a preferred embodiment, both the single-swab and double-swab devices may include a common swab assembly (so that robotic equipment can be used to manufacture both single-swab and double-swab devices), and the double-swab assembly is manufactured by fastening two single-swab assemblies 5A and 5B to a double (dual) stem handle 8 (see, e.g., FIG. 7). Having a single swab assembly commonly used for single and double swab devices with a locking swab stem handle (such as locking tab 8B that locks into corresponding features on swab stems 6A and 6B as illustrated and / or described elsewhere herein) provides significant advantages in assembly cost and time. FIG. 8 is a diagram of a double swab assembly using a double stem handle, showing an exemplary locking tab for permanently (barring breakage) securing two single swab assemblies into a double swab assembly. As will be appreciated, stem handle 8 is configured with an opening and locking feature for securing only one swab assembly in single swab device embodiments, as will be understood by those skilled in the art.

[0048] The present invention may utilize a wide variety of strips as desired for a particular application. In one additional feature, a strip for testing for THC (parent compound or metabolites) may be positioned adjacent the opening to the swab tube 2B, so that saliva is initially forced onto the THC detection strip. Increasing the efficiency of THC testing is an important feature of the present invention. See other sections for additional examples of strips, analytes, etc.

[0049] 9-19, additional preferred exemplary embodiments are described. As illustrated in FIG. 9, in an alternative preferred embodiment, housing 2 includes an internal tab 2AA near the bottom of housing 2. Tab 2AA extends downward within the bottom cavity portion of housing 2 and includes an opening 2BB, as also illustrated in FIG. 10. Such preferred embodiments preferably include a bottom cap 34, which includes tab 35 with protrusions 36 (two such protrusions 36 are provided in certain preferred embodiments), which engage with opening 2BB so that bottom cap 34 is preferably locked to housing 2. In such preferred embodiments, bottom cap 34 includes key opening 36A into which a key or tool (illustrated by dotted line 36B in FIG. 13) may be inserted to disengage protrusion 36 from opening 2BB, thereby allowing bottom cap 34 to be removed from housing 2. In certain preferred embodiments, tape 36C (which may be adhesive tape or other pierceable blocking material) covers opening 36A, thereby providing evidence of tampering. In use, tool 36B (or other protrusion) pierces tape 36C and engages protrusion 36 (to remove bottom cap 34). In this manner, vial 32 (similar to vial 15 described elsewhere herein) may be accessed and removed by piercing tape 36C and removing bottom cap 34, such as for laboratory confirmation of the oral fluid sample therein, preferably using an LC-MS instrument. An intact tape 36C provides evidence that the unit has not been opened or tampered with.

[0050] Additional details of bottom cap 34 are shown in FIG. 13 for illustrative purposes, illustrating tool 36B (shown in dotted lines in FIG. 13 to illustratively show a member inserted into opening 36A to spread projections 36 and facilitate removal of bottom cap 34) engaging tabs 35 to cause movement of projections 36 (to disengage from opening 2BB). Tool 36B is illustrated as having two parallel or substantially parallel protruding members (shaped much like the tips of a flat-head screwdriver) that engage tabs 35. The exact shape may vary; what is important is that tool 36B can extend through hole 36A and cause sufficient movement of projections 36 so that bottom cap 34 can be removed by the tool. Bottom cap 34 preferably (but optionally) has opening 32A into which the bottom end of vial 32 extends, facilitating viewing of vial 32 from the bottom, etc. Ribs or members 32B are provided to engage vial 32 and help ensure that the vial is held securely in housing 2 (and does not become loose due to vibration, for example, during transport of the device). Contact between ribs / members 32B exerts pressure on vial 32, causing vial 32 to resist rotation out of housing 2. Vial 32 is secured to housing 2 via screws 37 (similar to the screws described elsewhere herein).

[0051] Referring again to Figure 9, along with Figures 11A and 11B, an alternative upper body top cap 4' is illustrated. Top cap 4' preferably has a flat top 4C as shown, and preferably has tabs 4B that extend downward to engage strip card / carrier (or cassette) 3, helping to hold cassette 3 in place so that, when the device is in use, the bottom tip of the strip carried in cassette 3 is positioned near the bottom of test chamber 2C of housing 2 and in contact with oral fluid. Top cap 4' preferably has an ultrasonic welding energy director surface 4A that engages with housing 2 so that it can be joined to housing 2, preferably by ultrasonic welding. While adhesive or other fastening elements may be used to secure the top cap 4' to the housing 2, ultrasonic welding has been found to preferably provide a low-cost, airtight, and watertight secure fastening mechanism, and also provide tamper resistance to the strip inside the testing chamber 2C (air evacuation is provided by opening 20 sealed by seal 11B, as described elsewhere in this application).

[0052] Referring again to FIG. 9, swab assemblies 5A and 5B are illustrated in the lowered, locked position. As also illustrated, swab stems 6A and 6B each include a saliva indicator strip 6D (similar to indicator strip 27 described elsewhere herein), each of which includes a color-changing area 6C that preferably changes color (for example) from a first color (e.g., white) to a second color (e.g., red) when oral fluid is drawn up from the absorbent tip of the swab (swabs 12A and 12B) onto the strip 6D on swab stems 6A and 6B. In a preferred embodiment, indicator strip 6D enables appropriate oral fluid to be absorbed into swabs or sponges 12A and 12B (see also FIGS. 1 through 6C) and provide an indication that the oral fluid will contact the test strip in cassette 3 and occupy a substantial volume of vial 32 when swab assemblies 5A and 5B are inserted and locked into housing 2. As illustrated, indicator strip 6D (or 27) may have color change area 6C on one of the indicator strips, and in preferred embodiments, the color change areas 6C on both swabs of the double swab device face in the same direction, either upward or downward as shown.

[0053] Referring again to Figures 9 and 10, further sealing features of additional exemplary preferred embodiments will be described. As previously discussed, it will be understood that seals 9A and 9B are provided on the upper portions of swab stems 6A and 6B, providing an interior-to-exterior seal for both swab tubes 2A and 2B by pressure contact of seals 9A and 9B with the walls of swab tubes 2A and 2B. Seal 9B serves the additional purpose of sealing opening / vent 20 when swab assemblies 5A and 5B are fully inserted into housing 2, preferably in the locked position. As will be understood from the drawings and description herein, seals 9A and 9B are configured to form a type of stop seal, or a circular contour seal, about opening / vent 20 and the top of swab tubes 2A and 2B. In the previously discussed exemplary preferred embodiment, lower seals 11A and 11B are formed similarly to seals 9A and 9B. In an alternative exemplary preferred embodiment, seals 11A and 11B are formed differently.

[0054] 9 and 10 illustratively show lower seals 11A' and 11B' (shown in cross section) having a shape adapted to form a sliding seal (rather than a stop seal). Applicant has discovered that certain embodiments having a sliding or syringe-type lower seal allow for reduced friction or resistance when inserting the swab assembly into the swab tube. As illustrated in this embodiment, seals 11A' and 11B' are preferably formed with a contoured or textured profile, in contrast to the circular contours of seals 9A and 9B. In one illustrative example, seals 11A' and 11B' have one or more, preferably a plurality (two shown by way of example) of fins or O-rings (e.g., protruding seal members), which are spaced apart as shown, but integrally formed, such as by a second-shot or overmolding injection molding process. Such fins or O-rings provide a sliding or syringe seal to prevent or inhibit upward fluid movement as swab assemblies 5A and 5B are inserted and moved downwardly into swab tubes 2A and 2B. As swabs 12A and 12B are compressed by the downward movement of swab assemblies 5A and 5B into swab tubes 2A and 2B, fluid is expelled from swabs 12A and 12B, increasing pressure, and seals 11A' and 11B' provide a seal to prevent upward fluid flow toward the top of the housing, thereby facilitating fluid flow into vial 32 and test chamber 2C. At the same time, because excessive force required to fully insert swab assemblies 5A and 5B can be undesirable for user experience, swab seals 11A' and 11B' are provided with a contoured or finned structure or a textured shape to provide a proper seal with improved sliding resistance.In a further alternative embodiment, again in contrast to the stopper-type seals of seals 9A and 9B, seals 11A' and 11B' are textured in a manner to reduce sliding resistance, rather than having raised fins or O-rings in a manner that provides a sliding / syringe-type seal. What is important is that each of seals 9A / 9B and 11A' / 11B' is tailored and optimally configured for its respective function, as will be understood from the description and drawings herein, and is preferably formed by the same manufacturing process, such as a second shot or overmolding injection molding process, that forms both types of seals on swab stems 6A and 6B.

[0055] Additional exemplary preferred embodiments illustrated in Figures 9-19 also include a vented thread / gasket sealing mechanism, which is illustratively further described herein. Figures 9, 10, 16A-16D, 18A, and 18B show gasket 30, which is preferably shaped like a funnel and preferably has an extension 30D that extends into vial 32 to direct the flow of fluid (which may be oral fluid) into vial 32 as swab 12A is compressed upon insertion into housing 2. Gasket 30 has opening 30F through which fluid passes into vial 32. In a first position, indicated by the height of gasket 30 in FIG. 16B, the upper portion 30A of the gasket is above the top of vial 32 and rests on ledge 2G of housing 2, which is a slightly reduced diameter portion of the vial-side housing-tube (2H in FIG. 16B, similar to swab tube 2A described elsewhere herein). Lip 30E of gasket 30 rests on ledge 2G, and frictional interference between upper portion 30A and the wall of vial-side housing-tube 2H creates a seal to prevent the passage of oral fluid. In this first position, as swab assembly 5A is inserted and lowered into housing 2, swabs / sponges 12A and 12B are compressed, causing oral fluid to be expelled from swabs / sponges 12A and 12B and flow through opening 32F into vial 32 (and into test chamber 2C via the previously described fluid communication channel, as previously described). The swabs / sponges 12A and 12B are further compressed downward to a compressed position as shown illustratively in Figures 9 and 10. In the second position shown in Figure 16C, the gasket 30 preferably has an upper portion 30A that contacts the side peripheral wall at the lower end of the vial tube 2H, a lower surface 30C that contacts downwardly the upper peripheral surface of the vial 32, and a neck surface 30B that contacts the inner peripheral wall of the neck portion of the vial 32 (on the outside of which the vial 32 has threads 37 that engage corresponding threads on the housing 2 to secure the vial 32 to the housing 2).

[0056] According to preferred embodiments, gasket 30 is formed from a flexible, yet relatively rigid, elastomeric material, preferably a TPE (thermoplastic elastomer) or other polymeric or rubber-like material. According to preferred embodiments, gasket 30 has a durometer hardness greater than 50, more preferably in the range of 70 to 90. According to certain preferred embodiments, gasket 30 is a flexible material having a durometer hardness of 80 + / - 5 to 10%. Applicant has discovered that a gasket 30 of this composition has sufficient compressibility to desirably retain the gasket 30 in a first position while preventing oral fluid from flowing around the gasket 30 while in the first position, but as pressure increases during downward movement of the swab assemblies 5A and 5B, it is released under moderate pressure and moved downward across the swab tube 2H to a second position, thereby bringing surfaces 30B and 30C into contact with corresponding surfaces of the vial 32 and surface 30A into contact with the peripheral wall of the vial tube 2H of the housing 2, preventing oral fluid from flowing around the gasket 30 while in the second position.

[0057] Certain preferred embodiments configure and arrange the gasket 30, housing 2, and vial 32 as illustrated and described herein to provide an improved air vent, resulting in reduced backpressure and improved fluid extraction efficiency for a user attempting to push swab assemblies 5A and 5B into a locked position within housing 2. As illustratively shown in FIGS. 14 and 15, a notch 38 is formed in the lower end of threaded wall 37A of housing 2. Notch 38 may be tapered or contoured on its outer edge to provide clearance with at least the lower end of threaded wall 37A of housing 2 (arrows may be drawn to show air flow from inside the vial, around lower tip 30D, up into the neck of vial 32, and out notch 38 around the threads). When vial 32 is secured to housing 2 using threads 37 of vial 32 and threaded wall 37A of housing 2, the upper lip of vial 32 may contact housing 2 and seat snugly, while notch 38 ensures that an airtight seal is not created at this point of contact. Notch 38 thus allows air venting through threads 37 / threaded wall 37A. According to this embodiment, a seal to prevent leakage of oral fluids is achieved via gasket 30, as previously described. Thus, as swabs / sponges 12A and 12B are compressed, air is vented through notch 38 and threads 37 / threaded wall 37A, while promoting fluid flow into vial 32, and the operator will notice a reduction in back pressure when pushing the entire swab assembly into its final, locked position within housing 2. As can be seen, gasket 30 facilitates a linearly movable, two-position valve / seal embodiment or member where in a first (unsealed, deflated) position of swab tube 2A, air is deflated to the outside of the device, and under the compressive pressure of the swab the gasket linearly moves / down across swab tube 2H to a second (sealed / non-deflated) position at swab 2B where air is not deflated to the outside of the device and similarly fluid does not escape to the outside of the device.

[0058] As illustrated in Figures 12 and 16B-16C, housing 2 preferably includes openings 2F into which protrusions 8A on either side of the swab's upper collar 8C engage to lock the entire swab assembly into housing 2. As shown, protrusions 8A are preferably angled so that an upper ledge locks into opening 2F in housing 2, although other shapes of protrusions may be used in other embodiments. Importantly, the entire swab assembly locks into housing 2, inhibiting or preventing removal of the swab assembly and preventing / deterring tampering. Also shown, opening 8E is provided to engage the stem of a swab, preferably having a similar protrusion, to lock the swab stem in place, and opening 8F is provided to secure a corresponding feature on top cap 8D of the swab assembly, as illustrated in Figure 12.

[0059] As also illustrated in Figures 16A and 16D, the housing 2 preferably has a raised (preferably sloped or contoured) central portion 2D on the floor of the housing 2, upon which the lower end of the cassette(s) 3AA (Figure 9) rests. This raised central portion of the floor helps direct the fluid from the cassette tube 2I of the housing 2 to the lower end of the strip inserted into the cassette(s) 3AA by using gravity to force the oral fluid to flow from the central region of the test chamber 2C toward the edge where the leading edge of the strip is preferably positioned, thereby facilitating testing of the fluid through the strip. The housing 2 of Figures 9 and 10 includes a passageway / channel 23 from the tube 2I (similar to the swab tube 2B described elsewhere herein) into the test chamber 2C of the housing 2 containing the cassette 3AA, and an upper air opening / vent 20 as described above with respect to other preferred embodiments. 16A, the floor of the tube 2I preferably includes a plurality of raised protrusions 2E that help compress the swab / sponge 12B, facilitating the release of oral fluid from the swab / sponge 12B and its movement out of the tube 2I into the cavity housing the cassette 3AA and into the passage / channel 23. See Figures 3 and 4 and the associated discussion regarding the passage / channel 23 and opening / vent 20.

[0060] FIG. 17 illustrates an alternative preferred embodiment of a cassette for holding test strips, having one or more channels, generally shown and described as cassette 3AA. As will be appreciated by those skilled in the art, it should be understood that the present invention contemplates embodiments including one or two such cassettes 3AA (or similar cassettes) on one or both sides of housing 2. As illustrated in FIG. 17, the rightmost channel 3DD (a channel is a receptacle or holding area for test strips) includes a protrusion or island 3CC that elevates the strip from the bottom floor of channel 3DD (three such protrusions or islands 3CC are shown in this exemplary embodiment). In this manner, the back side of the strip is spaced (thus reducing contact) from the material (preferably plastic) comprising cassette 3AA. Additionally, channel 3DD includes side protrusions 3BB for positioning the strip so that the sides of the strip do not contact the sidewalls of channel 3DD. The side projections 3BB are preferably on either side of the channel 3DD, but preferably not directly opposite each other as shown (although in other embodiments, the side projections 3BB are directly opposite each other). In this way, the side edges of the strip are spaced from and do not contact the side walls of the material comprising the cassette 3AA. The combination of the projections / islands 3CC and the side projections 3BB causes the strip to nearly float within the channel 3DD, reducing contact with the material comprising the cassette 3AA. As will be understood by those skilled in the art, a label is typically provided to cover the strip positioned within the cassette 3AA. Applicant has found that cassettes 3AA having one or more (up to all) channels configured as shown provide improved detection of substances such as THC. According to certain preferred embodiments, a strip for detecting the presence or absence of THC is placed in a channel, such as channel 3DD, positioned at the rightmost or leftmost channel of a cassette 3AA (having multiple channels, such as the six channels shown in FIG. 17 or the seven channels exemplified in FIGS. 1 and 2) to more optimally contact oral fluid.In an alternative preferred embodiment, all such channels of cassette 3AA have protrusions / islands 3CC as shown for channel 3DD in FIG. 17, and also have side protrusions 3BB.

[0061] In a preferred embodiment, cassette 3AA also has protrusions 3EE, which act to position cassette 3AA away from the front surface of housing 2 and have been found to reduce upward capillary rise of fluid between cassette 3AA and housing 2. In this embodiment, protrusions 3EE may contact the front surface of housing 2, while the main surfaces of cassette 3AA are spaced from and do not contact the front surface of housing 2. In addition, as shown, cassette 3AA may optionally have side legs having a tapered or sloped shape, thus providing a smaller dimension at the bottom of the legs and a larger dimension at the upper portion of the legs. In this way, a smaller dimension is presented to the fluid at the bottom of test chamber 2C, further reducing the occurrence of capillary rise or fluid contact with the material of cassette 3AA.

[0062] As illustrated in Figure 19, a retaining clip 40 is provided, and the entire swab assembly, as shown in Figure 8, may be secured by clamp 40B, while clamp 40A is clamped to vial tube 2H. In this manner, the entire swab assembly is secured to the outside of housing 2, and the swab assembly / housing combination may then be passed through automated packaging equipment. According to such an alternative preferred embodiment, the swab assembly may be packaged in a plastic bag for hygienic reasons and secured to housing 2 in a manner suitable for automated packaging.

[0063] Applicant's exemplary embodiments expressly include single-swab devices, which omit the confirmatory vial side of the device, including the swab tube and swab assembly in fluid communication with the confirmatory vial. Thus, the housing 2, test chamber 2C, opening / vent 20, channel 23, seals 9B, 11B, 11B', and other features, along with cassette 3AA and variations thereof described and illustrated herein, are also desirably used with single-swab devices.

[0064] As will be appreciated by those skilled in the art, the teachings of co-pending U.S. application Ser. No. 15 / 417,905, which is incorporated by reference herein, are generally applicable to the exemplary preferred embodiments described herein. By way of additional explanation, and not by way of limitation, some of those teachings are set forth below.

[0065] Analyte Screening Embodiments of the present invention provide analyte screening devices, including rapid screening lateral flow chromatography immunoassays, for the simultaneous qualitative or quantitative detection of analytes in a fluid sample. For example, but not limited to, the fluid sample can be saliva, urine, blood, mucus, water, or a fluid extract of a solid or semi-solid material, such as stool or a mucus or liquid biopsy tissue. The fluid sample can also be an environmental sample, such as, but not limited to, soil, dust, water, plant material, insects, animal material, or a fluid extract of any of these. The fluid sample can also be a food or beverage, such as, but not limited to, a liquid beverage, a liquid-containing food, or a fluid extract of a solid, semi-solid, or powdered food or beverage. The fluid sample can also contain genomic or proteomic material for testing and analysis.

[0066] An embodiment of the present invention includes at least one membrane test strip in fluid communication with a sample receiving member and capable of indicating the presence or absence of at least one analyte above or below a threshold concentration in a fluid sample using a lateral flow chromatography assay.

[0067] In an embodiment of the invention, the lateral flow chromatography assay is a competitive assay, in which the analyte in the fluid sample competes with a competing reagent for binding to an anti-analyte antibody. For example, the anti-analyte may be labeled, and the competing reagent may be immobilized in the test zone of the membrane test strip. After the fluid sample reaches the dye zone, it encounters the labeled anti-analyte antibody. If the analyte is present in the fluid sample above a predetermined threshold concentration, the analyte saturates the binding sites of the labeled anti-analyte antibody; otherwise, some or all of the labeled anti-analyte antibody remains free to bind to the competing reagent. As the fluid sample moves along the membrane test strip by capillary action, it carries the labeled anti-analyte antibody with it to the test zone. The test zone contains an immobilized competing reagent, which may be the analyte, a fragment of the analyte, an epitope of the analyte, a molecular mimic of the analyte, an anti-idiotypic antibody, or any other molecule capable of competing with the analyte for binding to the anti-analyte antibody. If the analyte is present above a predetermined threshold concentration, the labeled anti-analyte antibody will be saturated and will not bind to the immobilized competing reagent, resulting in no signal in the test zone; otherwise, the anti-analyte antibody will be unsaturated and will be able to bind to the competing reagent, resulting in a signal in the test zone.

[0068] Thus, according to embodiments of the present invention using a competitive assay, an analyte-negative fluid sample (containing a lower than predetermined concentration of analyte) will produce a line in the test zone based on capturing the labeled anti-analyte antibody, whereas an analyte-positive fluid sample will not produce a colored line in the test zone because the analyte in the fluid sample will saturate the labeled antibody, preventing capture in the test zone.

[0069] In certain embodiments of the present invention, the lateral flow chromatography assay is a sandwich assay, in which the analyte must be present for the labeled anti-analyte antibody to be captured in the test zone. For example, the analyte antibody may be a labeled antibody, and a second anti-analyte antibody may be immobilized in the test zone. For example, the fluid sample encounters the labeled anti-analyte antibody after reaching the dye zone. If the analyte is present in the fluid sample, it will bind to at least a fraction of the labeled anti-analyte antibody. As the fluid sample moves along the membrane test strip by capillary action, it carries the labeled anti-analyte antibody along and reaches the test zone. The test zone contains an immobilized anti-analyte antibody, which may be more reactive with a different epitope of the analyte than the labeled anti-analyte antibody. If the analyte is present in the fluid sample, it forms a scaffold for the labeled antibody to be immobilized in the test zone. The fraction of labeled antibody captured in the test zone is thus determined by the concentration of the analyte in the fluid sample. If the analyte of interest is present above a predetermined threshold concentration, a sufficient fraction of the labeled antibody will be captured, resulting in a visible signal in the test zone; otherwise, an insufficient fraction of the antibody will be captured and no signal will be visible in the test zone.

[0070] Thus, according to embodiments of the present invention using a sandwich assay, an analyte-positive fluid sample will produce a colored line in the test zone of the membrane test strip due to capture of the labeled antibody in the test zone, while an analyte-negative fluid sample will not produce a thin line in the test zone because it does not capture the labeled antibody.

[0071] Some embodiments of the present invention include active controls to indicate proper functioning and completion of the assay. For example, the dye zone may contain a labeled control protein, such as, but not limited to, a labeled control antibody, and the control zone of the membrane test strip may contain an immobilized control reagent capable of capturing the labeled control protein, such as an antibody or control analyte. The control zones may also be located distal to each test zone on the membrane test strip, such that the fluid sample encounters each test zone before encountering the control zone. Reaction of the labeled control protein with the immobilized control reagent produces a colored line in the control zone, indicating that an appropriate amount of fluid sample was added, membrane wicking occurred, and that the assay was performed properly.

[0072] Some embodiments of the invention simultaneously test for multiple analytes, for example, by using membrane test strips that can simultaneously test for multiple analytes (e.g., by containing multiple anti-analyte antibodies in the dye area and having multiple compatible test areas) and / or by using multiple membrane test strips in the same device. Some embodiments of the invention include membrane test strips that use both competitive and sandwich assays, for example, on different membrane test strips within a device and / or on the same membrane test strip within a device.

[0073] Certain embodiments of the present invention may provide a quantitative determination of the concentration of an analyte present in a fluid sample. For example, a device may include multiple membrane test strips with different amounts of anti-analyte antibody, resulting in different sensitivities to the analyte, and which of the membrane test strips may or may not exhibit a colored line in the test zone, indicating the concentration of the analyte.

[0074] antibody Certain embodiments of the present invention use antibodies for the detection of analytes. As used herein, the term "antibody" (Ab) includes monoclonal antibodies, polyclonal antibodies, multispecific antibodies (e.g., bispecific antibodies), and antibody fragments, so long as they exhibit the desired activity. As used herein, the term "monoclonal antibody" refers to an antibody obtained from a population of antibodies that is substantially homogeneous, i.e., the individual antibodies comprising the population are identical except for possible natural mutations that may be present in minor amounts.

[0075] The terms "labeled antibody" and "labeled control protein" refer to an antibody or protein that is directly or indirectly conjugated to a label. The label is a detectable compound or composition that may be detectable itself, including but not limited to, a dye, a colloidal metal (including but not limited to, colloidal gold), a radioisotope, or a fluorescent compound, or, in the case of an enzyme label, may catalyze a detectable chemical alteration of a substrate compound or composition, or any combination thereof.

[0076] Analyte According to one embodiment of the present invention, an apparatus includes a device for testing a fluid sample for the presence or absence of an analyte. The present invention contemplates testing for any arbitrary analyte. Analytes that may be tested for include, but are not limited to, drugs of abuse or their metabolites, analytes indicative of the presence of pathogens or products of pathogens, allergens, pollutants, toxins, contaminants, analytes of diagnostic or medical value, antibodies to any of these, and any combination thereof.

[0077] According to certain embodiments of the present invention, analytes that may be tested for include drugs of abuse or their metabolites, including, but not limited to, 7-acetaminoclonazepam, alkyl nitrites, α-hydroxyalprazolam, alprazolam, 2-amino-2′-chloro-5-nitrobenzophenone, 7-aminoclonazepam, 7-aminonitrazepam, amitriptyline, amobarbital, amoxapine, amphetamine, anabolic steroids, androgens, androstadienone, aprobarbital, atropine, barbiturates, benzodiazepines, benzoylecgonine, benzylpiperazine, boldenone undecylenate, 4-bromo-2,5-dimethoxyphenethylamine, bovine growth hormone, butabarbital, butalbiamin, Tar, butripyrin, 4-chlordehydromethyltestosterone, chloroform, clomipramine, clonazepam, clostebol, cocaethylene, cocaine, codeine, codeine-6-glucuronide, cotinine, dehydroepiandrosterone, desipramine, desmethyldiazepam, desoxymethyltestosterone, dexmethylphenidate, dextroamphetamine, dextromethorphan, dextropropoxyphene, dextrorphan, 2,5-diamino-2'-chlorobenzophenone, diamorphine, diazepam, dibenzepin, dihydrotestosterone, dimenhydrinate, 2,5-dimethoxy-4-(n)-propylthiophenethylamine, 2,5-dimethoxy-4-ethylphenethylamine, 2,5-Dimethoxy-4-iodophenethylamine, dimethyl ether, dimethyltryptamine, dimethyltryptamine, diphenhydramine hydrochloride, dosulepin hydrochloride, dothiepin hydrochloride, doxepin, drostanolone, ecgonine, ecgonine methyl ester, ephedrine, ergin, estrenol, 5-estrogen, ethyl-5-(1'-methyl-3'-carboxypropyl)-2-thiobarbituric acid, 5-ethyl-5-(1'-methyl-3'-hydroxybutyl)-2-thiobarbituric acid, ethylestrenol, ethylphenidate, fentanyl, flunitrazepam, fluoxymesterone, furazabol, gamma-hydroxybutyric acid, 1-(β-D-glucopyranosyl)amobarbital, growth hormone, helo In, hexabarbital, human chorionic gonadotropin, human growth hormone, hydrocodone, hydromorphone, (+)-3-hydroxy-N-methylmorphinan, 3-hydroxyclonazepam, 11-hydroxy-tetrahydrocannabinol (11-hydroxy-THC), 3'-hydroxyamobarbital, p-hydroxyamphetamine, p-hydroxynorphedrine, imipramine, iprindole, kava, catamine, levomethylphenidate, iofepramine, lorazepam, lorazepam glucuronide, lysergic acid diethylamide, meperidine, mescaline, methanolone, mesterolone, metachlorophenylpiperazine, methadone, methamphetamine, methandrostenolone, methcathinone, 3,4-Methylenedioxyamphetamine, methanolone, methanolone enanthate, methylenedioxymethamphetamine (ecstasy), methylphenidate, methylphenobarbital, methyltestosterone, mibolerone, (+)-3-morphinan, morphine, nandrolone, nicotine, nitrazepam, N-methyl-dithianthamine, norbolethone, norcodeine, norethandrolone, norketamine, nortriptyline, opiates, opipramol, opium, oxaborone opionate, oxandrolone, oxazepam, oxycodone, oxymetholone, oxymorphone, pentobarbital, phencyclidine, phenethylamine, phenobarbital, 4-phenyl-4-(1-piperidinyl)-cyclohexyl Sanol, 1-phenyl-1-cyclohexene, phenylacetone, 5-[N-(1-phenylcyclohexyl)]-aminopentanoic acid, 1-(1-phenylcyclohexyl)-4-hydroxypiperidine, piperidine, protriptyline, psilocin, psilocybin, quinbolone, salvinorin A, scopolamine, secobarbital, thiopental sodium, stanozolol, terbutal, temazepam, testosterone, testosterone propionate, tetrahydrocannabinol (THC), THC-COOH, tetrahydrogestrinone, toluene, trenbolone, tricyclic antidepressants, 3-trifluoromethylphenylpiperazine, trimipramine, tryptamine, or any combination thereof. The minimum concentration level at which the presence of any particular drug or metabolite is detectable may be determined by minimum standards from various organizations, such as the National Institute on Drug Abuse (NIDA), the Substance Abuse and Mental Health Services Administration (SAMHSA), and the World Health Organization (WHO).

[0078] According to certain embodiments of the present invention, analytes that may be tested for include pathogens or pathogen products, including, but not limited to, Acanthamoeba, aflatoxin, digestive mycotoxins, altertoxin, amoeba, Anisakis, Ascaris lumbricoides, Bacillus arthritis, Bacillus cereus or their toxins, bacteria, bovine spongiform encephalopathy, Brucella, Calicivirus, Callimatobacterium granulomatis, Campylobacter, Campylobacter jejuni, Candida, Candida albicans, Cephalosporium, Chlamydia, Dia trachomatis, chronic wasting disease prion, citrinin, Clostridium botulinum or its toxin, Clostridium perfringens, Corynebacterium ulcerans, Coccieria burnetii, Creutzfeldt-Jakob disease prion, Cryptococcus neoformans, Cryptosporidium, Cryptosporidium parvum, cyclopiazonic acid, Cyclospora cayetanensis, cytokaicin, cytomegalovirus, Diphyllobothrium, Escherichia coli, Ebola, endotoxin, Entamoeba histolytica, enterovirus, ergopeptine alkaloids, ergot Alkaloids, ergotamine, Escherichia coli O157, eustrongylide, Fasciola hepatica, fatal familial insomnia prion, flatworms, Francisella tularensis, fumitremorgen B1, fumonisin, Fusarium, fusarochromanone, genital warts, Gerstmann-Straussler-Scheinker syndrome prion, Giardia lamblia, Giardia lamblia, Granuloma inguinale, H7 enterohemorrhagic, Haemophilus ducreyi, Helicobacter pylori, hepatitis, Hepatitis A, Hepatitis B, Hepatitis C, Hepatitis D, Hepatitis E, Herpes simplex virus, Histoplasma capsulatum, HIV, HIV -1, HIV-2, human papillomavirus, influenza, Kaposi's sarcoma-associated herpesvirus, kojic acid, culprion, Listeria monocytogenes, lolitrem alkaloids, Marburg virus, methicillin-resistant Staphylococcus aureus or its toxins, molluscs, moniliformin, mononucleosis, mycobacteria, Mycobacterium tuberculosis, mycoplasma, Mycoplasma hominis, mycotoxins, myrothecium, nanophytos, gonococci, nematodes, nivalenol, norovirus, auratoxin, oosporein, parasites, patulin, paxillin, penitrem A, phomopsin, protozoa,Flatworms, Plesiomonas shigelloides, Streptococcus pneumoniae, Pneumocystis jirovecii, prions, protozoans, rhinovirus, rotavirus, Salmonella, Sarcocystis hominis, Sarcocystis throminis, Scrapule prion, sexually transmitted diseases, Shigella, Shigella, sporidesmin A, S. reticulosus toxin, sterigmatocystin, streptococci, Streptococcus pneumoniae, Streptococcus pyogenes, Taenia solium, Taenia saginata, tapeworm, Taenia saginata, ringworm, Toxoplasma gondii, tremor-inducing mycotoxins, treponemes Ma pallidum, Trichinella spiralis, Trichoderma, Trichomonas vaginalis, Trichothecenes, Trichuris triculara, Typanosoma cruzi, Ureaplasma urealyticum, verrucocidin, bulculogen, Vibrio cholerae non O1, Vibrio cholerae O1, Vibrio enteritidis, Vibrio vulnificus, viruses, yeast infections, Yersinia enterocolitica, Yersinia pseudotuberculosis, zearalenore, zearalenone, antibodies to any of these, and any combination thereof.

[0079] According to certain embodiments of the present invention, analytes that may be tested for include, but are not limited to, allergens, including horse chestnut, alder, almond, animal products, mugwort, legumes, birch poison, birch, calyx, cat dander, celeriac, celery, Chenopodium album, cockroach, corn, dandruff, dog dander, drugs, dust mite excrement, egg white, eggs, Ferdiwan protein, fruit, fur, grass, hazel, hornbeam, insect bites, latex, legumes, local anesthetics, and These include corn, metals, milk, mold spores, mosquito saliva, mouse dander, nettles, olives, peanuts, peas, pecans, penicillin, plant pollen, plantain, sycamore, poplar, pumpkin, ragweed, rat dander, ryegrass, salicylates, seafood, sesame, sorrel, soybeans, soybeans, sulfonamides, linden, timothy grass, tree nuts, wood, bee venom, weeds, wheat, willow, antibodies to any of these, or combinations thereof.

[0080] According to certain embodiments of the present invention, the analytes tested for include pollutants, toxins, and contaminants, including, but not limited to, 1,2-dibromoethane, acrylamide, aldehydes, arsenic, artificial growth hormone, asbestos, benzene, benzopyrene, carcinogens (carcinogens), dichloro-diphenyl-trichloroethane, formaldehyde, kepone (chlorodecone), lead, mercury, methylmercury, nitrosamines, N-nitroso-N-methylurea, organochlorine insecticides, pesticides, polychlorinated biphenyls, polychlorinated dibenzofurans, polychlorinated dibenzo-p-dioxins, recombinant bovine growth hormone, recombinant bovine somatotropin, toluene, vinyl chloride, any antibodies thereto, or any combination thereof.

[0081] According to certain embodiments of the invention, the analytes tested include analytes of diagnostic or medical value, including, but not limited to, acid phosphatase, active B12, AFP, alanine aminotransferase, alanine aminotransferase, albumin, albumin BCG, albumin BCP, alkaline phosphatase, alpha-1 antitrypsin, alpha-1 glycoprotein, amikacin, ammonia, amylase, anti-CCP, anti-Tg, anti-TPO, apolipoprotein A1, apolipoprotein B, ASO, aspartate aminotransferase, aspartate aminotransferase, B12, beta2 microglobulin, beta2 microglobulin, BNP, CA125, CA125II, CA15-3, CA19-9XR, calcium, Carbamazepine, carbon dioxide, CEA, ceruloplasmin, cholesterol, CK-MB, complement C3, complement C4, cortisol, C-peptide, C-reactive protein, creatine kinase, creatinine, CRP variol, cyclosporine, cyclosporine and metabolites - whole blood, cyclosporine monoclonal - whole blood, D-dimer, DHEA-S, digitoxin, digoxin II, digoxin III, direct bilirubin, direct LDL, estradiol, ferritin, FLMII, folic acid, free carbamazepine, free phenytoin, free PSA, free T3, free T4, free valproic acid, FSH, gamma glutamyltransferase, gentamicin, glucose, glycated hemoglobin, haptoglobin, hCG, hemoglobin, homocysteine, ICTCI-, IGFBP-1, immunoglobulin, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin M, insulin, intact PTH, iron, K+, kappa light chain, lactate dehydrogenase, lactate, lambda light chain, LH, lidocaine, lipase, lithium, Lp, magnesium, metabolites, methotrexate II, microalbumin, MPO, myoglobin, Na+, N-acetyl-procainamide, neonatal bilirubin, NGAL, P-amylase, pepsinogen I, pepsinogen II, phenobarbital, phenytoin, phosphorus, prealbumin, procainamide, progesterone, prolactin, quinidine, rheumatoid factor, SHBG, silormus, STAT CK-MB, T4, tacrolimus, tacrolimus II, testosterone, Tg, theophylline, theophylline II, TIBC, TIMP-1, tobramycin, total bilirubin, total estriol, total protein, total PSA, total T3, total T4, transferrin, triglycerides, troponin-I, troponin-I ADV, TSH, T-uptake, UIBC, ultra HDL, urea nitrogen, uric acid, urine / CSF protein, valproic acid, vancomycin, vancomycin II, vitamin D, any antibodies thereto, or any combination thereof.

[0082] Receiving member According to some embodiments of the invention, the device includes a receiving member having an opening for receiving a fluid sample. For example, the receiving member may be sized to receive a fluid collector. In some embodiments of the invention, the receiving member may be in fluid communication with other components of the device, such as at least one membrane test strip, a sample retaining member, and / or an immunoassay-based fingerprint collection pad, through a channel, such as a tube, a pipe, a channel molded or engraved into the device, or any other suitable structure made from any suitable material, such as plastic, ceramic, metal, glass, wood, rubber, polymer, fiber-reinforced polymer, or any combination thereof.

[0083] According to certain embodiments of the invention, the channel or channels providing fluid communication between components may have different flow resistances, e.g., by having narrower, wider, longer, or shorter channels, channel portions, or openings than others, and / or may have vertically ascending or descending flow paths of different magnitudes, such that the fluid channels within the device have different degrees of flow resistance. For example, a channel providing fluid communication between the sample receiving member and at least one membrane test strip may have a greater flow resistance than at least one channel providing fluid communication between the sample receiving member and the sample retaining member, ensuring that a portion of the fluid sample is collected in the sample retaining member.

[0084] In certain embodiments of the invention, a single channel having multiple openings may connect the receiving member to each of the components of the device with which it is in fluid communication, such as at least one membrane test strip, sample retaining member, and / or immunoassay-based fingerprint collection pad.

[0085] In certain embodiments of the invention, the receiving member may include two or more chambers for receiving a multi-branched fluid collector, such as, but not limited to, a double-swab fluid collector. A component of the device may be connected to only one of the chambers. For example, in a two-chamber embodiment, only one chamber may be connected to the sample retaining member to ensure that a portion of the fluid sample is collected and stored without interaction with other components of the device.

[0086] Certain embodiments of the present invention may accommodate fluids of various viscosities, such as water, saliva, urine, blood, and liquids relevant to genomics and proteomics. Typically, this is achieved by varying the diameter of the channel or channels that provide fluid communication between the sample receiving member and other components of the device, for example, by providing larger channel diameters to accommodate more viscous fluids.

[0087] In certain embodiments of the present invention, a channel having dimensions compatible with a fluid having a viscosity similar to water provides fluid communication between the sample receiving member and at least one membrane test strip, and at least one channel having dimensions compatible with a fluid having a viscosity similar to water provides fluid communication between the sample receiving member and the sample retaining member.

[0088] In certain embodiments of the present invention, a channel having dimensions compatible with a fluid having a viscosity similar to that of urine provides fluid communication between the sample receiving member and at least one membrane test strip, and at least one channel having dimensions compatible with a fluid having a viscosity similar to that of urine provides fluid communication between the sample receiving member and the sample retaining member.

[0089] In certain embodiments of the present invention, a channel having dimensions compatible with a fluid having a viscosity similar to saliva provides fluid communication between the sample receiving member and at least one membrane test strip, and at least one channel having dimensions compatible with a fluid having a viscosity similar to saliva provides fluid communication between the sample receiving member and the sample retaining member.

[0090] In certain embodiments of the invention, a channel having dimensions compatible with a fluid having a viscosity similar to blood provides fluid communication between the sample receiving member and at least one membrane test strip, and at least one channel having dimensions compatible with a fluid having a viscosity similar to blood provides fluid communication between the sample receiving member and the sample retaining member. In certain embodiments of the invention, a channel having dimensions compatible with a fluid having a viscosity similar to mucus provides fluid communication between the sample receiving member and at least one membrane test strip, and at least one channel having dimensions compatible with a fluid having a viscosity similar to mucus provides fluid communication between the sample receiving member and the sample retaining member.

[0091] In certain embodiments of the present invention, a channel having dimensions compatible with a fluid having a viscosity similar to that of a fluid associated with cell separation provides fluid communication between the sample receiving member and at least one membrane test strip, and at least one channel having dimensions compatible with a fluid having a viscosity similar to that of a fluid associated with cell separation provides fluid communication between the sample receiving member and the sample retaining member.

[0092] In one embodiment of the present invention, a channel with dimensions compatible with a fluid having a viscosity similar to that of a liquid biopsy, such as proteomics or genomics, provides fluid communication between the sample receiving member and at least one membrane test strip, and at least one channel with dimensions compatible with a fluid having a viscosity similar to that of a liquid biopsy provides fluid communication between the sample receiving member and the sample retaining member. Proteomics is the study of proteins. Genomics is a branch of molecular biology concerned with the structure, function, evolution, and mapping of genomes.

[0093] In certain embodiments of the invention, the receiving member may have an inner surface, e.g., a lower surface, against which an absorbent material, such as an absorbent material present in a fluid collector, may be compressed, thereby releasing a fluid sample from the absorbent material. For example, the absorbent material may be compressed directly between a compression member present on the fluid collector and the lower surface of the receiving member, or the receiving member may provide structural support to facilitate compression of the absorbent material between the compression member and a housing that at least partially surrounds the absorbent material.

[0094] Sample holding member According to certain embodiments of the present invention, the device includes a sample retaining member. The sample retaining member may be used to securely contain a portion of the fluid sample, such as an aliquot sample. The retained portion of the fluid sample may be used for further testing, such as to confirm a test result obtained using a membrane test strip or to test for the presence or absence of an analyte in the fluid sample. The retained portion of the fluid sample may also be used to confirm the identity of a subject through analysis of identifying characteristics of the subject, such as, but not limited to, DNA, cells, proteomics, metals, and liquid biopsy.

[0095] According to one embodiment of the present invention, the sample retaining member comprises an absorbent material, such as a pad or sponge, or is made from a woven or non-woven fibrous or fabric-like material, such as cellulose or cellulose derivatives, cotton, hydrophilic foam, wood pulp, polyvinyl alcohol fiber, or any combination thereof. The sample retaining member may include an absorbent material that is part of the sample collection device. The absorbent material may be surrounded by a barrier, such as a liquid-impermeable material, including but not limited to plastic, ceramic, metal, glass, wood, rubber, polymer, fiber-reinforced polymer, or any combination thereof, to prevent the retained sample from leaking or evaporating. In some embodiments of the present invention, the absorbent material may be removably attached to the device, facilitating removal of the retained fluid sample. In some embodiments of the present invention, the absorbent material may be removed using a needle, for example, by puncturing the barrier surrounding the absorbent material. The retained sample may then be removed into a needle-equipped syringe, for example, by drawing suction on the syringe.

[0096] According to certain embodiments of the present invention, the sample retaining member includes a reservoir defining a volume for storing a fluid sample. In one embodiment of the present invention, the sample retaining member may be a vial made from a frangible or nearly unbreakable material, including but not limited to glass, plastic, ceramic, metal, metal foil, wood, rubber, polymer, fiber-reinforced polymer, or any combination thereof. In certain embodiments of the present invention, the reservoir may be removed using a needle that pierces the wall of the reservoir. For example, the reservoir may include a region of reduced wall thickness and / or a pierceable member made from a soft, pierceable, or breakable material, including but not limited to pierceable plastic, ceramic, metal, glass, metal foil, wood, rubber, polymer, fiber-reinforced polymer, or any combination thereof. The retained sample may then be removed by, for example, drawing a syringe with a needle attached thereto to create suction. In certain embodiments of the present invention, the reservoir may be removably attached to the apparatus, such as, but not limited to, via a linear weakened portion that may allow the reservoir to be disconnected from the apparatus, via a threaded connection between the sample retaining member and the fluid sample testing device, or via a pivot lock connection between the sample retaining member and the fluid sample testing device.

[0097] According to certain embodiments of the present invention, the removable sample retaining member may be coded to be linked or matched with the fluid sample testing device, such as by, but not limited to, the same or associated identification or serial number on both the sample retaining member and the fluid sample testing device, the same or associated bar code information on both the sample retaining member and the fluid sample testing device, and the inclusion of a radio frequency identification device (RFID) on the sample retaining member or on the sample retaining member and the fluid sample testing device. RFID employs the use of electromagnetic or electrostatic coupling in the radio frequency (RF) portion of the electromagnetic spectrum to uniquely identify an object; such unique identification information may be information specific to the sample donor or information specific to the fluid sample testing device.

[0098] According to certain embodiments of the present invention, the sample retaining member contains substances to facilitate further use of the sample, including, but not limited to, stable preservatives that can preserve the integrity of the sample, such as substances that inhibit microbial growth, kill microorganisms, inhibit sample leakage, inhibit sample evaporation, inhibit chemical or enzymatic degradation of materials in the sample, support the survival of cells or other microorganisms in the sample, or any combination thereof.

[0099] According to some embodiments of the present invention, the sample retaining member may be bonded to the fingerprint pad, for example, such bonding may provide a safeguard against the retained sample becoming separated from the fingerprint.

[0100] According to certain embodiments of the present invention, the sample retaining member may be in fluid contact only with the sample receiving member and not with any other components of the device.

[0101] The retained fluid sample may be used for further confirmatory testing, including, but not limited to, gas chromatography, liquid chromatography, mass spectrometry, liquid or gas chromatography coupled with mass spectrometry, polymerase chain reaction, DNA sequencing, enzyme-linked immunosorbent assay, Western blotting, growth culture, or any combination thereof, using the retained fluid sample.

[0102] fluid sampler In one embodiment, the device includes a fluid collector for collecting a fluid sample. The present invention is intended for collecting samples from a particular subject, such as a human subject, or for testing environmental samples, such as, but not limited to, air, water, soil, or any other substance, or food or beverage, or a liquid extract of any of these. The fluid collector is operatively associated with the device. The fluid collector may be removably coupled to the device / fixed to the device, or may include multiple units, one or more of which are fixedly or removably coupled to the device.

[0103] In certain embodiments of the present invention, the fluid collector includes an absorbent material or swab capable of absorbing a desired amount of fluid sample. The absorbent material may be made of any suitable material known to those skilled in the art, including, but not limited to, a pad or sponge, or made from woven or non-woven fibrous or fabric-like materials, such as, but not limited to, cellulose or cellulose derivatives, cotton, hydrophilic foam, wood pulp, polyvinyl alcohol fibers, or any combination thereof. In certain embodiments of the present invention, the fluid collector includes a compression member capable of compressing the absorbent material, which may be used to expel air from the absorbent material prior to collection of the fluid sample and / or to promote the flow of the fluid sample into the absorbent material by creating suction as the absorbent material returns to its uncompressed state. The compression member may also be used, for example, to compress the absorbent material to expel any fluid sample contained therein.

[0104] In one embodiment of the present invention, the fluid collector includes multiple collection swabs. For example, a bifurcated fluid collector with double swabs may be implemented to collect samples. In one embodiment, each swab in a multiple-swab fluid collector may be selected based on the swab's particular collection characteristics. For example, in a double-swab fluid collector, each swab may include materials that support the collection of different samples, such as the collection of different cellular materials.

[0105] Sufficiency indicators on the collector are also contemplated. For example, without limitation, a color indicator may appear or disappear when sufficient sample has been collected, e.g., when a sufficient amount has been absorbed to reach the location of the sufficiency indicator in the absorbent material. According to certain embodiments of the invention, the sufficiency indicator may operate in conjunction with the absorbent material and may be protected from direct contact with the source of the fluid sample by a transparent barrier, such as plastic or glass, such that the fluid sample reaches the sufficiency indicator only by passing through the absorbent material.

[0106] The color of the sufficiency indicator may be in the form of a letter or symbol that appears or disappears when a sufficient sample has been collected. For example, the sufficiency indicator may be a diffusible dye, where dilution of the dye by the fluid sample causes the color to disappear, indicating that a sufficient amount of sample has been collected. In some embodiments of the invention, a non-diffusible dye and a diffusible dye may be used in combination together such that when the diffusible dye disappears, the non-diffusible dye remains to provide an informational message, for example, the diffusible dye may form the letter "not" in the word "insufficient," and when a sufficient sample has been collected, the non-diffusible dye remains to form the word "sufficient."

[0107] The sufficiency indicator may be a pH-sensitive substance that changes color when it encounters a sample. For example, multiple pH-sensitive indicators may be preset to respond to different pH values, such that a color change is observed depending on whether the sample is acidic, basic, or neutral. According to some embodiments of the present invention, a pH-altering substance, such as an acid or base, may be disposed within the absorbent material, such that the sample has the correct pH to cause the desired color change in the sufficiency indicator.

[0108] A closure member may be used that can seal the open end of the sample receiving member when the fluid collector is inserted therein. For example, the closure member may be sized to fit snugly within the opening in the open end of the receiving member, and the closure member or the open end of the receiving member may comprise a compressible material, including but not limited to natural rubber such as vulcanized rubber, synthetic rubber such as neoprene rubber or nitrile rubber, plastic, ceramic, or any combination thereof, that can be disposed at the interface between the closure member and the opening in the open end of the sample receiving member to create a seal, such as an airtight or watertight seal, when the sample receiving member receives the fluid collector.

[0109] A device for locking the fluid collector within the sample receiving member after the fluid collector has been inserted into the sample receiving member is contemplated. The locking means may prevent the fluid collector from being removed from the sample receiving member after it has been inserted therein. The means for locking the fluid collector within the sample receiving member may include at least one protrusion extending from the fluid collector, which may cooperate with at least one protrusion positioned on the inner surface of the sample receiving member, where such protrusion may include, for example, at least one locking tab and / or at least one annular ring. According to certain embodiments of the present invention, a closure member on the fluid collector may form a sufficiently secure closure to constitute a means for securing the fluid collector within the sample receiving member.

[0110] The sample receiving member may also include a tamper-evident seal such that any attempt to tamper with the contents of the device will result in a visible indication, such as a visible tear or break in an imprinted seal, such as tape or adhesive foil having letters, symbols, or a signature thereon. Such a tamper-evident seal may be affixed to the device prior to use to create visual confirmation that the purpose of the device has not been altered before or after its use through the open end of the receiving member, and to create visual confirmation that the contents of the device have not been altered after inspection through the open end of the receiving member. According to certain embodiments of the invention, the means for locking the fluid collector within the sample receiving member may constitute a tamper-evident seal, in that any attempt to remove the fluid collector after insertion into the sample receiving member will result in visual damage to the device.

[0111] According to some embodiments of the invention, the fluid collector includes a handle, e.g., made of wood, plastic, ceramic, or metal, and disposed, e.g., at the end of the absorbent material, which may be removably attached, e.g., by an interference fit, glue, adhesive, or epoxy that breaks or separates when the handle is twisted and / or pulled, or by a structure that causes the handle to break, e.g., a line of weakness.

[0112] The fluid collector may include a housing at least partially surrounding the absorbent material. The housing may have a plurality of openings that allow the fluid sample to be absorbed into and leached from the absorbent material. The openings in the housing may include a filtering element capable of filtering particulate matter from the fluid sample, thereby reducing the amount of particulate matter that penetrates the absorbent material. The fluid collector may include a compression element capable of compressing the absorbent material relative to the housing. For example, the housing may be slidably coupled to the compression element, with the absorbent material disposed between the compression element and the inner surface of the housing, and the absorbent material may be compressed by movement of the compression element toward the inner surface of the housing. Some embodiments of the present invention include means for locking the absorbent material in a compressed state, including, but not limited to, threads, protrusions, and / or grooves that operate and cooperate with the compression element and the housing. The absorbent material may be released from the compressed state before, during, or after encountering the fluid sample, generating suction as the absorbent material returns to the released state to facilitate the flow of the fluid sample into the absorbent material. For example, the absorbent material may work in conjunction with a spring, such that compression of the absorbent material results in compression of the spring, and when compression is released the spring assists in returning the absorbent material to its uncompressed state.

[0113] In certain embodiments of the invention, the fluid collector operates in conjunction with a lid for a fluid container, such as, but not limited to, a urinalysis cup. For example, an absorbent material may be disposed on the inside of the lid, such that attachment of the lid to the fluid container results in contact between the absorbent material and the fluid sample. In certain embodiments of the invention, the portion of the fluid collector that includes the lid may be removably associated with the portion of the fluid collector that includes the absorbent material, allowing the absorbent material to be separated from the lid. The associated movement of the fluid collector and lid may be facilitated, for example, by the lid including means for capturing rotation of a portion of the fluid collector relative to the lid, such as, but not limited to, a protrusion on one member and a groove or slot on the other member cooperating to release the means for securing the absorbent material in compression.

[0114] saliva producing substances The present invention contemplates the use of saliva-generating substances. The saliva-generating substance induces or increases saliva production in a subject. For example, without limitation, the saliva-generating substance may be a sugar, a salt, an acid, or any combination thereof. In some embodiments of the invention, the saliva-generating substance may be associated with the fluid collector, e.g., positioned on or within an absorbent material or housing. In some embodiments of the invention, the saliva-generating substance may be separate from the fluid collector and administered to the subject, e.g., in the form of a gum, candy, or powder, before, during, or after the fluid collector is inserted into the subject's oral cavity.

[0115] For example, but not limited to, sugars include monosaccharides, disaccharides, trisaccharides, oligosaccharides, polysaccharides, acarbose, allose, altrose, amylose, arabinose, carbohydrate, cyclodextrin, α-cyclodextrin, β-cyclodextrin, γ-cyclodextrin, deoxyglucose, dextrin, dihydroxyacetone, erythrose, erythrulose, ficoll, fructooligosaccharides, fructose, galactooligosaccharides, galactose, gentiobiose, glucosamine, glucose, glyceraldehyde, glycogen, The sugar may be maltose, gulose, idose, inositol, inulin, isomaltose, lactose, lyxose, maltose, maltosyl cyclodextrin, maltotriforce, mannan oligosaccharides, mannoheptulose, marinose, meletchetose, monitol, psiccae, raffinose, ribitol, ribose, ribulose, sedoheptulose, sorbitol, sorbose, sucrose, tagatose, talose, threose, trehalose, xylose, xylulose, or any combination thereof.

[0116] For example, but not limited to, the salt may be an inorganic salt, an organic salt, an acid salt, an alkali salt, a neutral salt, or an amino acid salt, or any combination thereof. The salt may include a cation and an anion. For example, but not limited to, the cation may be aluminum, ammonium, barium, beryllium, calcium, cesium, chromium(II), chromium(III), chromium(IV), cobalt(II), cobalt(III), copper(I), copper(II), copper(III), gallium, helium, hydrogen, hydronium, iron(II), iron(III), lead(II), lead(IV), lithium, magnesium, manganese(II), manganese(III), manganese(IV), manganese(VII), nickel(II), nickel(III), nitronium, potassium, pyridinium, silver, sodium, strontium, tin(II), tin(IV), zinc, or any combination thereof. The salt may be an ion, and the anion may be acetate, amide, tartrate, borate, bromate, bromide, carbonate, chlorate, chloride, chlorate, chromate, citrate, cyanate, dichromate, dihydrogenphosphate, fluoride, formate, glutamate, hydride, bicarbonate, hydrogen oxalate, hydrogen phosphate, hydrogensulfate, bisulfite, hydroxide, hypobromite, hypochlorite, iodate, iodide, nitrate, nitride, nitrite, oxalate, oxide, perchlorate, permanganate, peroxide, phosphate, phosphate, phosphite, pyrophosphate, sulfate, sulfide, sulfite, tellurite, thiocyanate, thiosulfate, or any combination thereof. For example, according to certain embodiments of the present invention, the salt may be sodium chloride or potassium chloride.

[0117] The acid may be any suitable acid known to those skilled in the art, such as acetic acid, acrylic acid, adipic acid, alginic acid, alkanesulfonic acid, amino acid, ascorbic acid, benzoic acid, boric acid, butyric acid, carbonic acid, carboxylic acid, citric acid, fatty acid, folic acid, formic acid, fumaric acid, gluconic acid, hydroiodic acid, hydrobromic acid, hydrochloric acid, hydroquinosulfonic acid, isoascorbic acid, lactic acid, maleic acid, malic acid, malonic acid, methanesulfonic acid, nitric acid, oxalic acid, p-toluenesulfonic acid, parabromophenylsulfonic acid, phosphoric acid, propionic acid, salicylic acid, stearic acid, succinic acid, sulfuric acid, tannic acid, tartaric acid, thioglycolic acid, toluenesulfonic acid, uric acid, or any combination thereof.

[0118] Fingerprint Identification Some embodiments of the present invention include a fingerprint pad to provide identification of individuals associated with a test, such as the test subject, the test administrator, and / or one or more witnesses. The fingerprint pad may use any suitable fingerprint capture method, such as, but not limited to, ink-based, immunoassay-based, electronic, semi-inkless, or inkless. In some embodiments of the present invention, the fingerprint pad may be capable of capturing multiple fingerprints, for example, by having multiple fingerprint pads, or by having a single fingerprint pad large enough to accommodate multiple fingerprints, or by having an electronic fingerprint pad.

[0119] The fingerprint pad may be an ink-based fingerprint pad. Some embodiments of the present invention include a dispenser capable of dispensing ink capable of generating a signal in the ink-based fingerprint pad. The fingerprint pad may also be inkless or semi-inkless, e.g., requiring no ink or compatible with an activating agent that appears clear on the subject's skin and is easily washed off the subject's skin, or that is easily removed, e.g., when the subject rubs their hands together. According to some embodiments of the present invention, the inkless fingerprint pad may be an immunoassay system, e.g., as described in U.S. Pat. No. 6,352,663 issued to Raoof A. Girgais on March 5, 2002 (the "'863 patent") and U.S. Pat. No. 5,244,815 issued to Raoof A. Girgais on September 14, 1993 (the "'815 patent"), both of which are incorporated herein by reference in their entireties. The fingerprint pad of the immunoassay system may or may not be in fluid communication with the sample receiving member. Other embodiments of the present invention may incorporate various features of the embodiments disclosed in the '863 and '815 patents. In embodiments of the present invention having an inkless or semi-inkless fingerprint pad that requires an activator to produce a signal, the device may also include a dispenser for dispensing the activator. According to some embodiments of the present invention, the fingerprint pad may have a surface, such as an absorbent or sticky surface, that can collect sweat, oil, and / or skin cells when a finger is pressed against it, and further processing may be required to provide clear visualization of the fingerprint.

[0120] According to some embodiments of the present invention, the inkless fingerprint pad may be an electronic fingerprint pad, including, but not limited to, an optical scan fingerprint reader or a solid-state fingerprint reader. Some embodiments of the present invention include a memory element, including, but not limited to, a volatile or non-volatile memory, such as a hard disk, floppy disk, magnetic tape, optical disk, flash memory, holographic memory, EEPROM, RAM, DRAM, SDRAM, or SRAM, connected to the fingerprint pad for storing one or more fingerprints. According to some embodiments of the present invention, the electronic fingerprint pad may have electrically charged surface elements, where portions of the surface that come into contact with the finger surface, such as the ridges on the finger surface, are electrically discharged, and the fingerprint is thus stored in the pattern of the discharged elements, whereby the fingerprint pattern may be stably stored in the surface after it is generated until it is read via connecting the device to an external device, such as, but not limited to, a base station. Some embodiments of the present invention include means for transmitting the captured fingerprint to an external device or network, including but not limited to a hardwired connection using wires, cables, or via a docking station or docking connector using a connection such as but not limited to USB, IEEE1394, serial, parallel, or SCSI, or a wireless connection using, for example, infrared, RF, IEEE802.11, Bluetooth, IEEE802.15, or Wi-Fi.

[0121] In some embodiments of the present invention, a cover covers the fingerprint capture pad. The cover may be secured using a variety of mechanisms, including, but not limited to, a tab and slot connector, a latch, a spring latch, adhesive tape, or security tape. The cover may be secured before and / or after fingerprint capture.

[0122] Although the present invention has been described herein with reference to specific embodiments, various modifications and variations can be made without departing from the scope of the invention as set forth in the claims. Combinations of embodiments are expressly contemplated unless the embodiments are specifically mutually exclusive. The claimed invention may include more than one embodiment disclosed herein. Accordingly, the specification and drawings should be regarded in an illustrative rather than a restrictive sense, and all modifications and variations are intended to be included within the scope of the present invention. Any advantages, benefits, or solutions described herein with respect to particular embodiments are not intended to be construed as critical, essential, or essential features or elements of any or all claims.

[0123] The present invention is sometimes described in this application in connection with exemplary embodiments. Descriptions related to these embodiments are presented to allow various features and embodiments of the invention to be expressed in the context of exemplary applications. After reading this description, it will become apparent to one skilled in the art how the invention can be implemented in different alternative environments. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

[0124] The above description is presented to enable any person skilled in the art to make and use the invention. The general principles described herein may be applied to embodiments and applications other than those described in detail below without departing from the spirit and scope of the invention as defined in the appended claims. The present invention is not intended to be limited to the embodiments shown, but is to be accorded the widest scope consistent with the principles and features described herein.

[0125] In addition, although certain features of the invention may be disclosed with respect to only one of the embodiments, such features may, if desired, be combined with one or more other features of other embodiments. It is therefore intended that the claims cover all such modifications or embodiments that fall within the true scope of the invention.

[0126] Various drawings may depict exemplary configurations or structures of the present invention, which are done to facilitate understanding of the features and functions that may be included in the present invention. The present invention is not limited to the exemplary configurations or structures illustrated in the drawings, and the desired features may be realized through various alternative configurations and structures. In fact, it will be apparent to those skilled in the art how alternative functional, logical, or physical divisions and configurations may be implemented to achieve the desired features of the present invention. In addition, many different component module names may be applied to the various compartments other than those shown herein. Additionally, with respect to flowcharts, operational descriptions, and method claims, the order of steps presented herein does not require that various embodiments be performed in the same order to perform the described functions, unless the context dictates otherwise.

[0127] Terms and phrases used in this application, and variations thereof, unless expressly stated otherwise, should be construed as open-ended rather than limiting. For example: the term "including" should be read in the sense of "including without limitation"; the term "examples" is used to present illustrative instances of the described item, not an all-inclusive or exclusive listing thereof; the terms "a" or "an" should be read in the sense of "at least one," "one or more," etc.; and adjectives such as "conventional," "traditional," "usual," "standard," "known," and similar terms should not be construed to limit the described items to items available during a given period or at a given time, but rather should be read to encompass conventional, traditional, ordinary, or standard technology that may be available or known at any time, now or in the future. Similarly, when this application refers to technology that would be apparent or known to those of ordinary skill in the art, such technology encompasses technology that would be apparent or known to those of ordinary skill in the art at any time, now or in the future.

[0128] A group of things joined by the conjunction "and" should not be read as requiring that each and every one of those things be present in the group, but rather should be read as "and / or" unless expressly stated otherwise. Similarly, a group of things joined by the conjunction "or" should not be read as requiring mutual exclusivity within the group, but rather should also be read as "and / or" unless expressly stated otherwise. Furthermore, although items, elements, or components of the invention may be described or claimed in the singular, the plural is also contemplated as being within the scope of the invention unless limitation to the singular is expressly stated.

[0129] The presence of broader words and phrases such as "one or more," "at least," "including but not limited to," or other similar phrases should not be read to mean that a narrower case is intended or required, when in some cases such broader phrases may be absent. The use of the term "module" does not imply that the components or functionality described or claimed as part of the module are all configured within a common enclosure. Indeed, any or all of the various components of a module, whether control logic or other components, may be combined or maintained separately within a single enclosure and may even be distributed across multiple locations.

[0130] Unless otherwise expressly stated, terms such as "first" and "second" are used to arbitrarily distinguish between the elements that such terms describe, and as such, these terms are not necessarily intended to indicate a temporal or other priority of such elements.

[0131] Additionally, various embodiments set forth herein are illustrated by way of example block diagrams, flow charts, and other illustrations. As will be apparent to one of ordinary skill in the art after reading this application, the illustratively described embodiments and various alternatives thereof can be practiced without limitation to the described examples. For example, block diagrams and their associated description should not be construed as mandating a particular configuration or architecture.

[0132] All publications and patents mentioned in the preceding portion of the specification are incorporated herein by reference. Various modifications and variations of the described methods and systems of the present invention will be apparent to those skilled in the art without departing from the scope and spirit of the invention. Although the present invention has been described in connection with specific preferred embodiments, it should be understood that the claimed invention should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention that are obvious to those skilled in the art or any related fields are intended to be within the scope of the following claims.

[0133] Those skilled in the art will recognize that different embodiments may be constructed in a similar manner, having different characteristics based on need, performance, or other criteria. Thus, those skilled in the art will understand that changes may be made to the above-described embodiments without departing from the broad concept of the present invention. It is understood, therefore, that the invention disclosed herein is not limited to the particular embodiments disclosed, but rather is intended to cover modifications within the spirit and scope of the present invention as defined by the appended claims.

[0134] While the present invention has been described in connection with specific embodiments thereof, many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, the embodiments of the invention described herein are intended to be illustrative and not restrictive. Various changes may be made without departing from the true spirit and full scope of the invention as described herein.

[0135] While the present invention has been described with reference to certain preferred and alternative embodiments, it is apparent that many substitutions, alterations, and variations will be apparent to those skilled in the art in light of the foregoing description. Accordingly, the present invention is intended to encompass all such substitutions and variations encompassed within the spirit and scope of the appended claims. For example, it should be understood that various systems, and applications and methods based on such systems, may be obtained in accordance with the various alternative embodiments described herein. The various refinements, alternatives, and additional features described herein may also be combined to provide additional advantageous combinations, etc., according to the present invention. Furthermore, as will be understood by those skilled in the art based on the foregoing description, various implementations of the preferred embodiments may be applied in various subcombinations to achieve at least some of the advantages and properties described herein, and such subcombinations are also within the scope of the present invention. All such refinements, improvements, and further applications of the present invention are within the scope of the present invention.

Claims

1. 1. A fluid sample testing device comprising: a housing including a test chamber and a first fluid collection tube having a first diameter and a second fluid collection tube having a second diameter, the test chamber in fluid communication with the first fluid collection tube; a sample holding vessel in fluid communication with the second fluid collection tube; first and second fluid collectors, the first fluid collector configured to be inserted vertically into the first fluid collection tube, such that, upon insertion into the first fluid collection tube, pressure is generated to expel fluid from the first fluid collector into the testing chamber through a first passageway connecting the testing chamber and the first fluid collection tube and air is passed from the testing chamber to the exterior of the fluid sample testing device through a second passageway connecting the testing chamber and the first fluid collection tube; and the second fluid collector configured to be inserted vertically into the second fluid collection tube simultaneously with insertion of the first fluid collector into the first fluid collection tube, such that, upon insertion into the second fluid collection tube, pressure is generated to expel fluid from the second fluid collector into the sample holding container; a gasket positioned on the second fluid collection tube, the gasket having an upper portion that engages with a wall of the second fluid collection tube and a lower portion that has a smaller diameter than the upper portion and is inserted into an opening of the sample holding container, the gasket being positioned in an upper position within the second fluid collection tube before the second fluid collection tube is inserted into the second fluid collection tube, and the gasket being positioned in a lower position within the second fluid collection tube after the second fluid collection tube is inserted into the second fluid collection tube, and in the lower position the gasket forms a seal with the sample holding container, and air is passed from the second fluid collection tube to the outside of the fluid sample testing device before the gasket is positioned in the lower position.

2. A fluid sample testing device as claimed in claim 1, wherein the first fluid collector has an upper seal portion which, when inserted substantially fully into the first fluid collection tube, seals the first passage connecting the testing chamber and the first fluid collection tube.

3. A fluid sample testing device as described in claim 2, wherein the first fluid collector has a lower seal portion configured to form a sliding seal between the lower seal portion and a surface wall of the first fluid collection tube when the first fluid collector is inserted into the first fluid collection tube.

4. A fluid sample testing device as described in claim 3, wherein the upper seal portion is configured to form a fixed seal against a first passage connecting the testing chamber and the first fluid collection tube, and is of a different shape than the lower seal portion.

5. A fluid sample testing device as claimed in claim 4, wherein the fixed seal is a stopper seal and the sliding seal is a syringe plunger seal.

6. The fluid sample testing device of claim 5, wherein the syringe plunger seal is formed having a plurality of spaced apart O-ring portions.

7. The fluid sample testing device of claim 5, wherein the syringe plunger seal is formed with a textured surface.

8. 10. The fluid sample testing device of claim 1, further comprising a cassette for holding one or more test strips, the cassette including one or more channels for holding the one or more test strips, and including a first channel for holding at least a first strip, the first channel having a plurality of protrusions from each of two opposing side walls of the first channel, the plurality of protrusions defining a central position at which the first strip is positioned, the plurality of protrusions positioning the first strip to reduce or prevent contact between the first strip and the side walls of the first channel, the first channel also having a floor having a plurality of raised portions, the plurality of raised portions positioning the first strip to reduce or prevent contact between the first strip and the floor of the first channel.

9. A fluid sample testing device as claimed in claim 1, wherein the second diameter is larger than the first diameter.

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