Diagnostic Test Equipment and Systems

Abstract

A method and device using targeted ion mobility spectrometry to detect SARS-CoV-2 virus and its variants by measuring the amount of free polyamines, including putrescine, spermidine, and spermine, in sublingual saliva samples. Other embodiments can provide fast, cost-effective point-of-care (POC) tests and test results for other viral and bacterial infections, including influenza, acute and chronic respiratory conditions, certain forms of inflammation, and certain abnormal cells in human subjects.

Description

[Technical Field]

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 402,746, filed August 31, 2022, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates generally to methods and systems using targeted ion mobility spectrometry for detecting the SARS-CoV-2 virus that causes COVID-19, as well as for detecting other viral and bacterial infections. [Background technology]

[0003] Current technology generally consists of diagnostic testing systems that utilize serum, nasal, or oropharyngeal samples, which often impose discomfort on the test subject and typically require the use of trained medical professionals for some portion of the test. Current technology also generally does not provide rapid, highly accurate results and typically requires costly laboratory resources, which can extend test completion times and result reporting by as many as several days. Summary of the Invention [Problem to be solved by the invention]

[0004] The systems and methods herein enable highly accurate diagnostic tests for specific viral or bacterial infections to be performed by non-specialists using non-invasively collected test samples to provide uniformly accurate and rapid results. [Means for solving the problem]

[0005] In one embodiment, the test provides qualitative detection of SARS-CoV-2, the causative agent of COVID-19. The system and method utilize ion mobility spectrometry (IMS) to isolate and detect ionized molecules of specific volatile organic chemicals, specifically specific polyamines extracted from the precursor ornithine. The system and method may be incorporated into a portable structure similar in form factor and overall appearance to hardware chassis assemblies utilized for desktop computers. Embodiments herein utilize the qualitative and quantitative capabilities of IMS analysis to provide a profile of targeted polyamines and utilize a hierarchical algorithm to identify positive cases of COVID-19 and distinguish infected from healthy test subjects.

[0006] One embodiment analyzes biological markers generated from metabolic pathways and their activity levels in the body due to viral infection. It features a rapid turnaround time (less than one minute) and POC testing capabilities, and is characterized by high accuracy, sensitivity, and specificity. This embodiment is designed to operate in non-laboratory locations, enabling rapid qualitative diagnostic screening of large populations and allowing non-specialists to collect and process test samples safely, reliably, and cost-effectively.

[0007] In one embodiment, an apparatus for detecting viruses comprises: a case having a sample inlet configured to receive a sample, the sample inlet comprising a vaporization source configured to vaporize the sample into a plurality of molecules; a dopant holder fluidly coupled to the sample inlet and configured to provide a carrier gas to a cavity of the sample inlet; a drift tube assembly fluidly coupled to the sample inlet and configured to receive the carrier gas comprising the plurality of molecules, the drift tube assembly comprising: an ionization source positioned at a first end of the drift tube assembly and configured to ionize the molecules, an ion gate positioned downstream of the ionization source and configured to selectively allow a plurality of molecules of interest to flow toward a second end of the drift tube, and a detector plate positioned at the second end of the drift tube and configured to detect the plurality of molecules of interest and collect data for the plurality of molecules of interest; and a processor communicatively coupled to the drift tube and configured to quantify the plurality of molecules of interest to provide a qualitative test result.

[0008] The vaporization source can be a tritium radiation source configured to vaporize the sample into a plurality of molecules, the tritium radiation source comprising less than 1 gigabecquerel (GBq) of tritium radiation. The vaporization source can be a heating source configured to vaporize the sample into a plurality of molecules, the heating source comprising a light bulb.

[0009] The ionization source can include a plurality of electrodes, the first ends of which are near the entrance to the drift tube, and the plurality of electrodes can include a plurality of rings made of at least one of plastic, metal, or ceramic.

[0010] The apparatus may include a pressure control assembly configured to provide pressurized air to each of the dopant holder and the drift tube assembly; an air pump including a motor and configured to draw air into the apparatus; a moisture trap configured to collect moisture and provide dry air to the pressure control assembly; and a pressure valve in fluid receiving communication with the air pump and in fluid supply communication with the moisture trap.

[0011] The drift tube assembly may further include a drift gas aperture positioned adjacent to the detector plate, The drift tube assembly is configured to receive the drift gas from the pressure control assembly.

[0012] The device may include a display located on the outer case and communicatively coupled to the processor, the display configured to receive selections from a user and display test results.

[0013] The device may include a sample inlet cover within the sample inlet, the sample inlet cover configured to seal the sample inlet when the device is not in use.

[0014] The device may include at least one printed circuit board containing a controller and an amplifier.

[0015] In another embodiment, a method for detecting a virus may include providing a sample to a sample inlet; selecting a vaporization source positioned within the sample inlet; vaporizing the sample into a plurality of target molecules comprising a plurality of molecules; selecting a carrier gas for chemically binding to and transporting the plurality of molecules; selecting an ion gate aperture size in an ion gate positioned within a drift tube assembly based on the size of the molecules; providing a carrier gas and a polyamine to a first end of the drift tube assembly; ionizing the molecules with an ionization source; encouraging a flow of the ionized polyamine through the ion gate to a second end of the drift tube assembly equipped with a detector plate; and detecting the amount of ionized molecules with the detector plate.

[0016] The method may include storing the amount of ionized molecules; and providing a qualitative test result based on the amount of ionized molecules.

[0017] The vaporization source can be a tritium radiation source configured to vaporize the sample into a plurality of molecules, the tritium radiation source comprising less than 1 gigabecquerel (GBq) of tritium radiation. The vaporization source can be a heating source configured to vaporize the sample into a plurality of molecules, the heating source comprising a light bulb.

[0018] The method may include selecting a temperature of the carrier gas and heating the carrier gas to the selected temperature.

[0019] The ionization source may include a plurality of ring electrodes made of at least one of plastic, metal, or ceramic.

[0020] In yet another embodiment, a method of sampling multiple samples using a virus detection device may include the steps of: withdrawing a sample from a subject; adding a reagent to the sample; providing the sample at a sample inlet located on the outer case of the device; performing a new test on the sample and storing data collected from the new test in a memory device; removing the sample from the sample inlet; and providing a qualitative test result by the device.

[0021] The method may include selecting a vaporization source positioned within the sample inlet; selecting a carrier gas configured to chemically bond with the target molecules based on a plurality of target molecules in the sample; and selecting an ion gate aperture size in an ion gate positioned within the drift tube assembly based on the size of ionized structures in the target molecules.

[0022] The method may include vaporizing a sample with a vaporization source into a plurality of target molecules, the target molecules comprising a plurality of molecules; providing a carrier gas and the target molecules to a first end of a drift tube assembly; ionizing the target molecules with an ionization source; urging the ionized polyamine to flow through an ion gate to a second end of the drift tube assembly comprising a detector plate; and detecting the amount of ionized molecules with the detector plate.

[0023] The vaporization source may be at least one of a tritium radiation source or a heating source; the ionization source may be a plurality of ring electrodes constructed of at least one of plastic, metal, or ceramic.

[0024] The foregoing and other features of the present disclosure will become more apparent from the following detailed description and appended claims, taken in conjunction with the accompanying drawings, in which: The present disclosure will be described with additional specificity and detail through the use of the accompanying drawings, with the understanding that these drawings illustrate only some implementations in accordance with the present disclosure and therefore are not to be considered limiting of its scope. [Brief explanation of the drawings]

[0025] [Figure 1] 1 is a flowchart of a method for determining the presence of a virus, according to one embodiment. [Figure 2A] 1 is a perspective view of an apparatus for determining the presence of a virus, according to one embodiment. [Figure 2B] 2B is a cross-sectional view of the device of FIG. 2A according to one embodiment. [Figure 2C] FIG. 2B is a top view of the device of FIG. 2A, according to one embodiment. [Figure 2D] 2B is a rear view of the device of FIG. 2A according to one embodiment. [Figure 2E] 2B is another rear view of the device of FIG. 2A according to one embodiment. [Figure 2F] FIG. 2B is a perspective view of a portion of the sample inlet and drift tube assembly of the apparatus of FIG. 2A, according to one embodiment. [Figure 2G] FIG. 2F is a perspective view of the drift assembly of FIG. 2E, according to one embodiment. [Figure 2H] FIG. 2B is a perspective view of the air pump of the device of FIG. 2A, according to one embodiment. [Figure 2I] FIG. 2B is a perspective view of a pressure valve in the device of FIG. 2A according to one embodiment. [Figure 2J] 2B is a perspective view of a moisture trap in the device of FIG. 2A according to one embodiment. [Figure 2K] FIG. 2B is a side perspective view of the device of FIG. 2A, according to one embodiment. [Figure 2L] FIG. 2B is a perspective view of a pressure control assembly in the device of FIG. 2A, according to one embodiment. [Figure 2M] 2B is a top view of a dopant holder in the apparatus of FIG. 2A according to one embodiment. [Figure 2N] FIG. 2B is a perspective view of a computer assembly in the apparatus of FIG. 2A according to one embodiment. [Figure 2O] FIG. 2B is a perspective view of a ventilation fan in the device of FIG. 2A according to one embodiment. [Figure 2P] FIG. 2B is a perspective view of a solid-state relay in the device of FIG. 2A according to one embodiment. [Figure 3] 1 is a flowchart of a method for detecting a virus using a device, according to one embodiment. [Figure 4] 1 is a flowchart of a current embodiment of an algorithm for detecting viruses using a device, according to one embodiment. [Figure 5] 1 is a flow chart illustrating a method for preparing a testing instrument for detecting viruses using a device, according to one embodiment. [Figure 6] 1 is a flow chart illustrating a method of performing a test to detect a virus using a device, according to one embodiment. [Figure 7A] 7 illustrates steps for performing a test to detect a virus using a device according to the embodiment of FIG. 6. [Figure 7B] 7 illustrates another step in performing a test to detect a virus using a device according to the embodiment of FIG. 6. [Figure 7C] 7 illustrates another step in performing a test to detect a virus using a device according to the embodiment of FIG. 6. [Figure 7D] 7 illustrates another step in performing a test to detect a virus using a device according to the embodiment of FIG. 6. [Figure 7E] 7 illustrates another step in performing a test to detect a virus using a device according to the embodiment of FIG. 6. [Figure 7F]7 illustrates another step in performing a test to detect a virus using a device according to the embodiment of FIG. 6. [Figure 7G] 7 illustrates another step in performing a test to detect a virus using a device according to the embodiment of FIG. 6. [Figure 7H] 7 illustrates another step in performing a test to detect a virus using a device according to the embodiment of FIG. 6. DETAILED DESCRIPTION OF THE INVENTION

[0026] Referring now to the exemplary embodiments illustrated in the drawings, specific language will be used herein to describe the exemplary embodiments. However, it should be understood that no limitation of the scope of the claims or the present disclosure is thereby intended. Alterations and further modifications of the inventive features illustrated herein, and additional applications of the principles of the subject matter illustrated herein that would occur to one skilled in the relevant arts and in possession of this disclosure, are to be considered within the scope of the subject matter disclosed herein. Other embodiments may be utilized and / or other changes may be made without departing from the spirit or scope of the present disclosure. The exemplary embodiments described in the Detailed Description are not meant to be limiting to the subject matter presented.

[0027] The embodiments described herein can be used with a variety of test sample specimen types to determine the presence of viruses, including the SARS-CoV-2 virus that causes COVID-19, as well as influenza A and B. Although examples are described herein for the detection of SARS-CoV-2 or influenza, the methods and systems can be used to detect other viruses as well.

[0028] In one configuration, a method 100 for determining the presence of a virus is shown in Figure 1. The functions of method 100 may be implemented using or performed by components detailed herein in connection with Figures 2A-2P. In some embodiments, an apparatus 200 may perform one or more of the functions of method 100, together or independently.

[0029] In step 102, the sample utilizes saliva collected from under the tongue using a cotton or synthetic-tipped swab. According to this embodiment, in step 104, approximately one to two drops of 15% KOH (potassium hydroxide) solution can be applied to the swab before placement in the test device to allow for initiation of sample decomposition. In step 106, vaporization of the sample occurs. Sample vaporization can occur by heating the sample using a heat source, such as an incandescent or halogen lamp, or other compatible heat source contained inside the housing. In other configurations, sample vaporization can occur using a tritium radiation source. The tritium radiation source contains less than 1 gigabecquerel (GBq) of tritium radiation. Next, in step 108, the vaporized sample and a carrier gas are mixed. The carrier gas is configured to chemically bond to the vaporized sample. In some embodiments, the carrier gas is heated to a desired temperature depending on the molecules of interest within the vaporized sample. For example, mixing of the sample vapor can be achieved by sending a heated carrier gas into a sample introduction chamber (e.g., a sample inlet cavity). In step 110, as the mixed vapor (e.g., a mixture of vaporized sample and carrier gas) enters the ionization region of the drift tube assembly, sample ionization is facilitated by heat generated by the electrodes. Here, discrete molecules of the target analyte are converted into ions with different chemical structure shapes and sizes. An ion gate / shutter in the drift tube assembly is briefly opened and closed to allow groups of ions to enter the drift region. In step 112, various ions move from a first end of the drift tube assembly near the inlet toward a detector plate located at the second end of the drift tube assembly. The movement of the various ions within the drift tube assembly depends on their size and shape and their interaction with the incoming drift gas. A constant current is maintained by an array of electrodes across the drift tube.Generally, smaller ions of interest move quickly and reach the detector plate, or array, located on the side of the drift tube assembly opposite the inlet first, followed by larger molecules. In this application, the smaller molecules of interest include putrescine, which reaches the detector plate first, followed by spermidine and then spermine. Each of these analyte molecules differs by one amine group (e.g., two amines for putrescine, three amines for spermidine, and four amines for spermine). In step 114, the software records the amount of each analyte. The relative proportions of each analyte can be obtained by transferring the values ​​into accompanying software that performs the conversion. A specific algorithm looks for a predetermined value of proportion and determines whether a particular analyte exceeds that threshold.

[0030] In step 116, a qualitative result is provided based on the amount of molecules (e.g., analytes). If only one of the three analytes exceeds the threshold, the sample is considered COVID-negative. However, if two of the three analytes exceed the threshold, the sample is considered COVID-positive. The result may be displayed on the screen of the device (e.g., an LED screen) or on a screen communicatively coupled to the device. The result may also be transmitted (wired or wirelessly) to another device, such as a cell phone or tablet computer, and presented as a notification, email message, text message, pop-up message, etc. The result may be stored in a database.

[0031] Various embodiments include methods and devices for detecting the SARS-CoV-2 virus and its variants, which cause COVID-19, using free polyamines from human sublingual saliva and utilizing targeted ion mobility spectrometry, incorporating the following elements:

[0032] An apparatus 200 for detecting a virus is shown in Figures 2A-2P. According to this embodiment, the apparatus 200 includes a metallic outer casing 202 (or other rigid housing). The metallic outer casing 202 is configured to house the various components of the apparatus 200 and to couple various external components to the apparatus 200.

[0033] The device 200 also includes a sample inlet 204. The sample inlet 204 is configured to receive a sample. For example, the sample may be a swab containing saliva. The sample inlet 204 defines a sample inlet cavity (e.g., a sample introduction cavity). The sample inlet cavity is configured to vaporize (e.g., volatilize) the sample. For example, a heat source or a tritium radiation source may be positioned within the sample inlet cavity to vaporize the sample.

[0034] The apparatus 200 further includes a dopant holder 206. The dopant holder 206 is configured to contain and provide a dopant or carrier gas to the sample inlet chamber, for example, the sample inlet chamber may receive a carrier gas and mix the carrier gas with the vaporized sample.

[0035] The apparatus 200 also includes a drift tube assembly 208. The drift tube assembly 208 includes an inlet fluidly connected to the sample inlet cavity. The inlet includes an ionization source. For example, the ionization source can be a plurality of electrodes, such as rings made of plastic, metal, or ceramic. In some embodiments, electrodes are positioned through the drift tube assembly 208 to provide a drift current within the drift tube assembly 208. The drift tube assembly 208 includes a fine-pore ion gate that selectively allows molecules or analytes to pass through the ion gate. Downstream of the ion gate, the drift tube assembly 208 includes a detector plate. The detector plate is configured to detect the amount of molecules. For example, a mixture of carrier gas and sample is provided to the inlet of the drift tube assembly and ionized. Electrodes drive flow through the ion gate toward the detector plate. The detector plate then quantifies the number of molecules that reach the detector plate.

[0036] The apparatus 200 further includes a pressure control assembly 210. The pressure control assembly 210 is configured to provide pressurized air to each of the dopant holder and the drift tube assembly. The pressure control assembly 210 may include various components, such as a filter. The drift tube assembly 208 may also include a gas aperture near the detector plate. The drift tube assembly is configured to receive drift gas from the pressure control assembly 210.

[0037] Apparatus 200 also includes an air pump 214 and a moisture trap 216. Air pump 214 is configured to draw air into apparatus 200, and moisture trap 216 is configured to collect moisture and provide dry air to pressure control assembly 210. Apparatus 200 further includes a pressure valve 218. Pressure valve 218 is in fluid receiving communication with air pump 214 and in fluid providing communication with moisture trap 216.

[0038] 2A shows a device with a test collection component communicatively coupled to a notebook computer. The computer may be a laptop computer, desktop computer, tablet computer, mobile phone, or other communication device. The computer may be a separate component or may be integrated into the device. The device thereby includes a processor, a non-transitory computer-readable memory containing instructions to be executed by the computer and containing data (e.g., in an access database), and a display (e.g., an LED).

[0039] The device 200 may include a processor 220 (e.g., a computer-readable medium, a motherboard, etc.) configured to receive, analyze, and store data, such as the amount of molecules detected by the detector plate. For example, the computer may analyze the data and provide a qualitative result (e.g., a positive result, a negative result, etc.) to the user. The device also includes a display 222 (e.g., an LCD display, etc.) configured to display (e.g., provide, show, etc.) the data, results, or other information to the user. The display may also be configured to receive selections of various settings from the user.

[0040] The device may include a sample inlet cover 224 disposed on the sample shoe 204. The sample inlet cover 204 is configured to seal the sample inlet cavity and to prevent unwanted objects or dust from entering the sample inlet cavity.

[0041] 2A-2G and 2N-2P, outer case 202 includes an opening 226. Opening 226 is configured to receive an insertion tube 228 of a test kit. A sample inlet cover 224 is placed over opening 226 when device 200 is not in use.

[0042] The apparatus also includes a plurality of tubes 230, which are configured to receive dopant from the dopant holder 206 and provide the dopant to the sample inlet 204. The apparatus 200 also includes a solid state relay 232 and a ventilation fan 234.

[0043] 2H and 2I, air pump 214 includes a motor 236, a first air conduit 238 configured to receive air from the pump and provide the air to pressure relief valve 218, and a second air conduit 240 configured to receive air from the air intake and provide the air to air pump 214. Apparatus 200 also includes a third air conduit 242 configured to receive air from pressure relief valve 218 and provide the air to moisture trap 216.

[0044] 2J, the moisture trap 216 can be positioned on an exterior portion of the outer case 202. For example, the device 200 can include a bracket 244 that mounts the moisture trap 216 to the outer case 202.

[0045] 2K, apparatus 200 may also include a plurality of external conduits 246 and a divider 248. The plurality of conduits are fluidly connected to moisture trap 216. Divider 248 divides the flow from moisture trap 216 into at least two separate flow paths to provide fluid (e.g., air, dry air, etc.) to various components within outer case 202. For example, the plurality of external conduits 246 may provide dry air to pressure control assembly 210 for carrier gas and drift gas.

[0046] As shown in FIG. 2L, pressure control assembly 210 includes a plurality of circuit boards 250 (eg, EPC boards, etc.).

[0047] As shown in FIG. 2M, the dopant assembly 206 includes a dopant holder 252 configured to contain a dopant, a heating jacket 254 configured to insulate the dopant holder 252, and an inlet 256 configured to receive dry air from the moisture trap 216.

[0048] In one configuration, a method 300 for detecting a virus is shown in Figure 3. The functions of method 200 may be implemented using or performed by components detailed herein in connection with Figures 2A-2P. In some embodiments, device 200 may perform one or more of the functions of method 300, together or independently.

[0049] 3 presents a high-level logic diagram illustrating the sequence of steps in this embodiment of the algorithm. The functions of method 300 may be implemented using or performed by components detailed herein in connection with FIGS. 2A-2P. In some embodiments, apparatus 200 may perform one or more of the functions of method 300, together or independently.

[0050] In step 302, all data is saved to defined fields in the access database, which can be stored internally and externally to the device 200. In step 304, the access database is verified and queries can be edited. The verified entries are then saved to the access database. In step 306, the access database prompts the user to verify any previous tests with a confirmation selection, a new test, or an additional test. In step 308, the self-test proceeds, an automatic self-clean is performed if necessary, and then, upon successful completion, prompts "Ready for Test." In step 310, selecting a new test prompts a further eight-step quality check to reconfirm readiness for testing to begin. In step 312, the user is prompted to add reagents, remove the sample inlet cover, and place the sample into the device. In step 314, the user is prompted to insert the sample into the inlet and confirm completion. In step 316, a series of 50 data readings are taken from the drift tube, with 256 data points read and recorded. In step 318, the collected data is stored in memory. In step 320, the recorded levels of the three polyamines and the drift gas for each distinct peak are determined. In step 322, the three polyamine values ​​are calculated with the drift gas value used as the denominator. In step 324, the calculation is complete. If two or more polyamine thresholds are met, it is a positive result (e.g., COVID positive), and if zero to one polyamine threshold is met, it is a negative result (e.g., COVID negative).

[0051] A method for preparing a test instrument to perform a diagnostic test is shown below and in Figure 4. The functions of method 400 may be implemented using or performed by components detailed herein in connection with Figures 2A-2P. In some embodiments, device 200 may perform one or more of the functions of method 400, together or independently.

[0052] In step 402, the software may be installed on a computer. It may be communicatively coupled to or integrated into the apparatus 200. In step 404, the computer is connected to a test device (e.g., apparatus 200) using a USB cable. In step 406, the device is connected to a surge-protected, uninterruptible power supply (UPS). In step 408, a laptop is connected to the UPS. In step 410, any necessary security keys or devices are connected to the laptop. In step 412, the test machine is turned on. In step 414, the connected laptop is turned on. In step 416, the software is launched. In step 418, a username and password are entered from drop-down menus, if necessary. In step 420, the software's run button on the screen is selected (e.g., clicked) to begin heating the unit. In step 422, once the tube temperature reaches 110°C, the "Ready to Test" button is selected (e.g., activated), and the instrument then indicates it is ready to begin testing.

[0053] As shown in FIG. 5, the following describes a method 500 for detecting a virus using an apparatus such as apparatus 200. For example, method 500 may include one or more of the following steps: The functions of method 500 may be implemented using or performed by components detailed herein in connection with FIGS. 2A-2P. In some embodiments, apparatus 200 may perform one or more of the functions of method 500, together or independently.

[0054] In step 502, the configuration and dimensions of the outer metal case are selected. The user may select the size and orientation of the device configuration (e.g., the orientation of the outer metal case). Step 502 is essential to ensure that all components of the device fit well inside the allotted space, with either a preferred horizontal or vertical configuration.

[0055] In step 504, an introduction mechanism is selected and a sample (e.g., liquid held in an absorbent swab) is collected and inserted (e.g., placed) into the testing device / machine. For example, if the sample is collected using a swab, the sample is extracted into the introduction mechanism, which is then inserted into the testing device / machine. Step 504 may include providing a reagent to the sample and placing the sample into the sample inlet.

[0056] In step 506, a volatilization source (e.g., a 50-100 W light bulb) is selected to be used to volatilize / vaporize the sample (e.g., a heating source, a radiation source, etc.). For example, the user may choose to use a heating source, such as a light bulb or a tritium radiation source.

[0057] In step 508, a carrier gas is selected, which depends on the type of volatilized molecule under study (e.g., polyamine, analyte, etc.). Additionally, either a single gas or a mixture of gases may be used as the carrier gas, which again depends on the chemical structure of the molecule under study. Furthermore, in step 508, depending on the molecule of interest in the sample, the user selects a carrier gas and may heat the carrier gas to be within a specific temperature range.

[0058] An ionization source is selected in step 510. For example, the ionization source may be a series of plastic, metal, or ceramic electrodes placed at the tip of a drift tube.

[0059] In step 512, the ion gate aperture size of the drift tube assembly is selected, which depends on the chemical structure of the ionized analyte under consideration. Larger ions require larger aperture sizes, and smaller ions require smaller aperture sizes. In step 512, the ion gate is selected such that even the largest ions will pass through the aperture of the ion gate.

[0060] In step 514, the type of ring electrodes (e.g., plastic, ceramic, metal, etc.) for the ionization source within the analyte / drift tube is selected. For example, the ionization source may include 21 rings, which may be constructed of plastic, metal, or ceramic, although other ring numbers and materials may be utilized and are consistent with this disclosure. These rings may be spaced apart at a distance within the drift tube assembly. The electrodes thereby direct the ionized sample stream toward the detector plate.

[0061] In step 516, appropriate air pumps and filtering devices are selected and connected to the sample introduction chamber, drift tube, control valve, and exhaust through-tube.

[0062] In step 518, a printed circuit board (PCB) is selected, containing controller, high voltage, and amplifier board functions along with components specific to the device under test. They can be installed inside the outer case. They are appropriately connected to other components using fasteners and cables.

[0063] In step 520, a drift gas is selected. The drift gas is provided to the drift tube assembly. According to some embodiments, the drift gas may be air.

[0064] In step 522, the device is configured so that the tested saliva sample is properly vaporized and the polyamines of interest are accurately ionized and accurately quantified. The processor utilizes an algorithm to analyze the generated quantitative data to determine a qualitative diagnostic result, positive or negative. The positive or negative result is communicated to the user (e.g., displayed via an LCD screen, etc.).

[0065] As shown in FIG. 6, a method 600 for performing a test is shown. Method 600 may include one or more of the following steps. The functions of method 600 may be implemented using or performed by components detailed herein in connection with FIGS. 2A-2P. In some embodiments, apparatus 200 may perform one or more of the functions of method 600, together or independently.

[0066] In step 602, the user clicks "Add a New Patient" on the screen, fills in the data, and then clicks "Save." In step 604, the user twists the swab handle to break the seal and remove the swab from its transparent tube. In step 606, the user uses a disposable swab to collect saliva from under the test subject's tongue. In step 608, the user places the swab with the collected saliva from the test subject back into the transparent tube. In step 610, the user clicks the "New Test" button on the screen. In step 612, the user removes the swab with saliva from the transparent tube and adds approximately one drop of reagent to the tip of the swab. In step 614, the user places the swab into the white test kit insertion tube. In step 616, the screen prompts the user to remove the sealed physical plug at the bottom front of the machine and firmly insert the white test kit tube into the machine. In step 618, the test results appear on the screen. The results should appear in less than one minute. In step 620, the user, when prompted on the screen, removes the white test kit insertion tube and discards all parts of the test kit using a suitable biohazard container. The user then replaces the machine's physical plug into the front of the machine. In step 622, based on the positive or negative result, the user may be instructed to follow a specific protocol.

[0067] Additionally, the user may repeat the steps to continue testing other samples. Once the user is finished testing the samples, the user turns the system off.

[0068] Figures 7A-7H show how to prepare the test device in conjunction with the method described in Figure 6. Figure 7A shows the user twisting the swab handle to break the seal and remove the swab from its transparent tube.

[0069] FIG. 7B shows a user using a disposable cotton swab to collect saliva from under the tongue of a test subject.

[0070] FIG. 7C shows the user placing the swab with the subject's collected saliva back into the transparent tube.

[0071] FIG. 7D shows the user removing the swab with saliva from the transparent tube and adding about one drop of reagent to the tip of the swab.

[0072] FIG. 7E shows the user placing the swab into the insertion tube of the white test kit.

[0073] FIG. 7F shows the user firmly inserting the white test kit tube into the machine.

[0074] FIG. 7G shows the test results appearing on a screen connected to the device.

[0075] FIG. 7H shows the user discarding the sample in an appropriate waste bin once the test is complete.

[0076] The various illustrative logic blocks, modules, circuits, and algorithm steps described in connection with the embodiments disclosed herein may be implemented in electronic hardware, computer software, or a combination of both. To clearly illustrate the interchangeability of hardware and software, the various illustrative components, blocks, modules, circuits, and steps have been described generally in terms of their functionality. Whether such functionality is implemented in hardware or software depends on the particular application and design constraints imposed on the overall system. Skilled artisans may implement the described functionality in various ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope of the present disclosure or the claims.

[0077] Computer software-implemented embodiments may be implemented in software, firmware, middleware, microcode, hardware description languages, or any combination thereof. A code segment or machine-executable instruction may represent a procedure, a function, a subprogram, a program, a routine, a subroutine, a module, a software package, a class, or any combination of instructions, data structures, or program statements. A code segment may be coupled to another code segment or a hardware circuit by passing and / or receiving information, data, variables, parameters, or memory contents. Information, variables, parameters, data, etc. may be passed, forwarded, or transmitted via any suitable means including memory sharing, message passing, token passing, network transmission, etc.

[0078] The actual software code or specialized control hardware used to implement these systems and methods does not limit the scope of the claims or this disclosure. Accordingly, the operation and behavior of the systems and methods have been described without reference to specific software code. It should be understood that software and control hardware can be designed to implement the systems and methods based on the description herein.

[0079] If implemented in software, the functions may be stored as one or more instructions or code in a non-transitory computer-readable or processor-readable storage medium. The steps of a method or algorithm disclosed herein may be embodied in a processor-executable software module, which may reside on a computer-readable or processor-readable storage medium. Non-transitory computer-movable or processor-readable storage media include both computer storage media and tangible storage media that facilitate transfer of a computer program from one location to another. A non-transitory processor-readable storage medium may be any available medium accessible by a computer. By way of example, and not limitation, such non-transitory processor-readable media may comprise RAM, ROM, EEPROM, CD-ROM or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other tangible storage medium. Any other tangible storage medium may be used to store desired program code in the form of instructions or data structures that can be accessed by a computer or processor. As used herein, disk and disc include compact discs (CDs), laser discs, optical discs, digital versatile discs (DVDs), Blu-ray discs, and floppy disks, where a "disk" generally reproduces data magnetically, while a "disk" reproduces data optically using a laser. Combinations of the above should also be included within the scope of computer-readable media. Additionally, the operations of a method or algorithm may reside as one or any combination or set of code and / or instructions in a non-transitory processor-readable medium and / or computer-readable medium, which may be embodied in a computer program product.

[0080] The foregoing description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the embodiments described herein and variations thereof. Various modifications to these embodiments will be readily apparent to those skilled in the art. The principles defined herein may be applied to other embodiments without departing from the spirit or scope of the subject matter disclosed herein. Thus, the present disclosure is not intended to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the following claims and the principles and novel features disclosed herein.

[0081] Although various aspects and embodiments have been described, other aspects and embodiments are contemplated. The various aspects and embodiments disclosed are for illustrative purposes only and are not intended to be limiting, the true scope and spirit of which is set forth by the following claims.

Claims

1. 1. An apparatus for detecting a virus, comprising: a case having a sample inlet configured to receive a sample, the sample inlet having a vaporization source configured to vaporize the sample into a plurality of molecules; a dopant holder fluidly connected to the sample inlet and configured to provide a carrier gas to the sample inlet cavity; a drift tube assembly fluidly coupled to the sample inlet and configured to receive the carrier gas comprising a plurality of molecules, an ionization source positioned at a first end of the drift tube assembly and configured to ionize the molecules; an ion gate positioned downstream from the ionization source and configured to selectively allow a plurality of target molecules to flow toward the second end of the drift tube; a detector plate positioned at the second end of the drift tube and configured to detect a plurality of molecules of interest and collect data for the plurality of molecules of interest; a drift tube assembly comprising: a processor communicatively coupled to the drift tube and configured to quantify a plurality of target molecules to provide a qualitative test result; An apparatus comprising:

2. 10. The apparatus of claim 1, wherein the vaporization source is a tritium radiation source configured to vaporize a sample into a plurality of molecules and having a tritium radiation of less than 1 gigabecquerel (GBq).

3. The apparatus of claim 1 , wherein the vaporization source is a heated source configured to vaporize a sample into a plurality of molecules and includes a light bulb.

4. 10. The apparatus of claim 1, wherein the ionization source comprises a plurality of electrodes, the first end being near an entrance to the drift tube.

5. The device of claim 4 , wherein the plurality of electrodes comprises a plurality of rings made of at least one of plastic, metal, or ceramic.

6. a pressure control assembly configured to provide pressurized air to each of the dopant holder and the drift tube assembly; an air pump having a motor and configured to draw air into the device; a moisture trap configured to collect moisture and provide dry air to the pressure control assembly; and a pressure valve in fluid receiving communication with the air pump and in fluid providing communication with the moisture trap; The apparatus of claim 1 further comprising:

7. 7. The apparatus of claim 6, wherein the drift tube assembly further comprises a drift gas aperture positioned adjacent the detector plate and configured to receive drift gas from the pressure control assembly.

8. 10. The device of claim 1, further comprising a display positioned on the outer case and communicatively coupled to the processor, the display configured to receive selections from a user and display test results.

9. 10. The device of claim 1, further comprising a sample inlet cover within the sample inlet, the sample inlet cover configured to seal the sample inlet when the device is not in use.

10. 10. The apparatus of claim 1, further comprising at least one printed circuit board containing a controller and an amplifier.

11. 1. A method for detecting a virus, comprising: providing a sample to a sample inlet; selecting a vaporization source positioned within the sample inlet; vaporizing the sample into a plurality of target molecules, the plurality of molecules comprising the plurality of molecules; selecting a carrier gas for chemically bonding and transporting a plurality of said molecules; selecting an ion gate aperture size in an ion gate positioned within the drift tube assembly based on the size of the molecule; providing the carrier gas and polyamine to a first end of the drift tube assembly; ionizing the molecules with an ionization source; urging the ionized polyamine to flow through the ion gate to a second end of the drift tube assembly comprising a detector plate; and detecting the amount of ionized molecules by the detector plate; A method comprising:

12. storing the amount of ionized molecules; and providing a qualitative test result based on the amount of ionized molecules; The method of claim 11 further comprising:

13. 12. The method of claim 11, wherein the vaporization source is a tritium radiation source configured to vaporize a sample into a plurality of molecules and having a tritium radiation of less than 1 gigabecquerel (GBq).

14. The method of claim 11 , wherein the vaporization source is a heated source configured to vaporize a sample into a plurality of molecules and including a light bulb.

15. The method of claim 11 further comprising the steps of selecting a temperature of the carrier gas and heating the carrier gas to the selected temperature.

16. The method of claim 11 , wherein the ionization source comprises a plurality of ring electrodes made of at least one of plastic, metal, or ceramic.

17. 1. A method of sampling a plurality of samples using a virus detection device, comprising: collecting a sample from a subject; adding a reagent to the sample; providing the sample to a sample inlet located on an outer casing of the device; performing a new test on the sample and storing data collected from the new test in a memory device; removing the sample from the sample inlet; and providing a qualitative test result with said device; A method comprising:

18. selecting a vaporization source to be positioned within the sample inlet; selecting a carrier gas configured to chemically bond the target molecules based on a plurality of target molecules in the sample; and selecting an ion gate aperture size in an ion gate positioned within a drift tube assembly based on the size of the ionized structure in the molecule of interest; 20. The method of claim 17, further comprising:

19. vaporizing the sample with a vaporization source into the plurality of target molecules comprising a plurality of molecules; providing the carrier gas and the target molecules to a first end of the drift tube assembly; ionizing the target molecules with an ionization source; urging the ionized polyamine to flow through the ion gate to a second end of the drift tube assembly comprising a detector plate; and detecting the amount of ionized molecules by the detector plate; 20. The method of claim 18, comprising:

20. the vaporization source is at least one of a tritium radiation source or a heating source; the ionization source is a plurality of ring electrodes made of at least one of plastic, metal, or ceramic; 20. The method of claim 19.

Images