CN-122003205-A - Sample collection and analysis system

Abstract

A sample collection system includes a housing including an air inlet configured to receive an exhaled air flow, a porous sample collection medium disposed within the housing, the porous sample collection medium including a sample receiving region, an air flow passage extending from the air inlet through the sample receiving region of the porous sample collection medium, an assay device configured to receive an eluted sample from the porous sample collection medium, and a liquid flow passage extending from the sample receiving region of the porous sample collection medium to the assay device. The porous sample collection medium includes one or more reagents disposed on the porous sample collection medium along a liquid flow path.

Inventors

• MICHAEL R. BERRIGAN
• Michael C. Wall
• MIKHAIL L. PEKUROVSKY
• Laura. R. Nerenge
• Sean C. Daozi
• MATTHEW S. STAY
• Kevin T. Reddy
• Peace M gill is graceful
• Giuseppe Debelis
• Ramasubramani Kuduwa Raman Tanumurti

Assignees

• 3M创新有限公司

Dates

Publication Date

20260508

Application Date

20241008

Priority Date

20231009

Claims (20)

1. 1. A sample collection and analysis system, the sample collection and analysis system comprising: a housing including an air inlet configured to receive an exhaled airflow; A porous sample collection medium disposed within the housing, the porous sample collection medium comprising a sample receiving area; an air flow path extending from the air inlet through the sample receiving area of the porous sample collection medium; an assay device configured to receive an eluted sample from the porous sample collection medium, and A liquid flow path extending from the sample receiving area of the porous sample collection medium to the assay device, The porous sample collection medium includes one or more reagents disposed on the porous sample collection medium along the liquid flow path.
2. 2. The sample collection and analysis system of claim 1, wherein the one or more reagents are disposed on an outer surface of the porous sample collection medium.
3. 3. The sample collection and analysis system of claim 1 or 2, wherein the one or more reagents are disposed throughout the thickness of the porous sample collection medium.
4. 4. The sample collection and analysis system of any one of the preceding claims, wherein the assay device comprises a conjugate pad comprising a conjugate, and a detection zone downstream of the conjugate pad.
5. 5. The sample collection and analysis system of any one of the preceding claims, wherein the liquid flow path extends from a liquid inlet to the detection zone of the assay device, and wherein the one or more reagents are disposed downstream of the sample receiving zone along the liquid flow path.
6. 6. The sample collection and analysis system of any one of the preceding claims, wherein the liquid flow path extends from a liquid inlet to the detection zone of the assay device, and wherein the one or more reagents are disposed along the liquid flow path upstream of the sample receiving zone.
7. 7. The sample collection and analysis system of any preceding claim, wherein the one or more reagents are arranged in a pattern.
8. 8. The sample collection and analysis system of any one of the preceding claims, wherein the one or more reagents are adhered to the porous sample collection medium by an adhesive.
9. 9. A method of manufacturing a sample collection and analysis system, the method comprising: Depositing one or more reagents on the porous sample collection medium to form a reagent zone; placing the porous sample collection medium within a housing along an airflow path extending from an air inlet to a sample receiving area on the porous sample collection medium, and An assay device is coupled with the housing forming a liquid flow path through the sample receiving area, through the reagent zone and onto or into the assay device.
10. 10. The method of claim 9, wherein the one or more reagents are disposed on an outer surface of the porous sample collection medium.
11. 11. The method of claim 9 or 10, wherein the assay device comprises a conjugate pad comprising a conjugate, and a detection zone downstream of the conjugate pad.
12. 12. The method of any one of claims 9 to 11, wherein the liquid flow path extends from a liquid inlet to the detection zone of the assay device, and wherein the one or more reagents are disposed downstream of the sample receiving zone along the liquid flow path.
13. 13. The method of any one of claims 9 to 12, wherein the liquid flow path extends from a liquid inlet to the detection zone of the assay device, and wherein the one or more reagents are disposed along the liquid flow path upstream of the sample receiving zone.
14. 14. The method of any one of claims 9 to 13, wherein the depositing of the one or more reagents comprises applying a powder comprising the one or more reagents onto the porous sample collection medium.
15. 15. The method of any one of claims 9 to 14, wherein the depositing of the one or more reagents comprises depositing an adhesive onto the porous sample collection medium, and adhering a powder comprising the one or more reagents to the adhesive.
16. 16. The method of claim 15, wherein the adhesive is deposited in a pattern.
17. 17. The method of claim 15 or 16, wherein the adhesive is applied by inkjet printing, stripe coating, gravure printing, flexographic printing, spray coating, screen printing, or a combination of two or more thereof.
18. 18. The method of any one of claims 9 to 17, wherein the depositing of the one or more reagents comprises charging a region of the porous sample collection medium and adhering a powder comprising the one or more reagents to the charged region.
19. 19. The method of claim 18, wherein the charging comprises tribocharging.
20. 20. The method of claim 18, wherein the charging comprises printing a charged substance onto the porous sample collection medium.

Description

Sample collection and analysis system Cross Reference to Related Applications The present application claims priority and benefit from U.S. provisional patent application serial No. 63/543,206 filed on 10/2023, 9, the disclosure of which is hereby incorporated by reference in its entirety. Background Diagnostic tests for testing the presence of viruses or other pathogens in the airways, throat or nasopharynx typically involve inserting a swab into the rear of the nasal passage, the middle turbinate region of the nasal passage, the anterior nares, the mouth or throat to obtain a sample. The swab is then inserted into the container and analyzed or sent to a laboratory for processing. Other diagnostic tests include collecting saliva samples, which are then placed in a container. Over the past few years, the need for rapid virus detection has not proliferated due to the COVID-19 pandemic. In order to control epidemic, the detection of SARS-CoV-2 virus needs to be scaled up in a number of different clinical and epidemiological contexts. Until recently, nasopharyngeal (NP) swabs have been the type of specimen of choice in the american centers for disease control and prevention (CDC) because such specimens are believed to provide the most reliable detection of infection in patients. However, there are conflicting reports as to which of several sample types carries the highest viral load. However, sensitivity is a complex problem because the detection of the upper respiratory tract (nasopharynx and oropharynx) is affected by a number of factors, including the course of the disease before the test and the limit of detection (LoD) of the RT-PCR analysis used. During an epidemic, the availability of NP swabs and establishing resources for NP collection sites with sample collection personnel is a critical bottleneck. To address these issues, healthcare systems have adopted a number of different strategies including having industry manufacturers participate in mass production of new 3D printed NP swabs, as well as evaluating different sample types and alternative sample (such as saliva) collection strategies. Nasal swab and saliva assessment is a rapidly growing area of interest, particularly because these specimen sample types involve less invasive procedures than NP swabs. Thus, a patient can collect such samples by himself with a simple set of instructions, thereby alleviating the need for trained medical personnel for sample collection. Many U.S. food and drug administration emergency use authority (FDA EUA) RT-PCR assays have approved the use of nasal swabs as the specimen type and saliva, but it is still unclear how well these samples perform as compared to NP swabs. To date, nasal swab studies have shown conflicting results, some researchers report similar test performance as NP swabs, while others find reduced sensitivity. Currently available at-home virus tests (e.g., COVID-19 tests) include nasal swabs and test kits (e.g., ELLUME ™ test, ABBOT ™ BinaxNOW™ test, and LUCIRA ™ monomer test kit). Tests using nasal swab specimens or saliva are counter-balanced with contaminants that may interfere with various diagnostic tests. Thus, these sample types require a purification step when tested using RT-PCR molecules. There is a need for a simpler and cleaner sample collection and analysis system and for easy sample elution and testing in an easy to use procedure. In addition, there is a need for a sample collection and analysis system that can also capture and elute samples with low SARS-CoV-2 viral loads that are still capable of transmitting viruses to others. There is also a need for a more accurate system to reduce human error and provide reliable test results with better repeatability. Disclosure of Invention There is a need for a low cost, simple to use, and reliable sample collection and analysis system that can be used by non-professionals to test collected samples for the presence of target viruses, target pathogens, or other target analytes. The sample collection and analysis system may include a sample collection device for collecting a sample from an exhaled air stream and a test assay device for determining the presence or absence of viruses, pathogens or other analytes in the collected sample. It is desirable to provide a system comprising a sample collection device and an assay device that are integrated or that can be coupled together prior to testing. The system may advantageously include reagents for use in the test. The system may further comprise all components for collecting and testing the sample. The system may be self-contained and optionally sterile. Unlike swabs and other test collection devices that may be contaminated during use and/or during testing, the self-contained and sterile system may improve the accuracy and reliability of pathogen testing due to reduced contamination and background noise. It is further desirable to provide a system that remains closed and independent after sample