Sample collection apparatus and methods for immunoassay testing

Patent metadata

Field	Value
Publication number	US-2023400394-A1
Application number	US-202118249325-A
Country	US
Kind code	A1
Filing date	Oct 19, 2021
Priority date	Oct 23, 2020
Publication date	Dec 14, 2023
Grant date	—

Abstract

A method of increasing a concentration of an antigen of a respiratory virus is provided. The method includes preparing a sample containing a first concentration of the antigen; contacting the sample containing the first concentration of the antigen to a first material having a negatively-charged surface, thereby capturing an amount of the antigen with the first material; contacting a second material to the first material to transfer the antigen from the first material to the second material, the second material having an ionic strength sufficient to release the captured antigen from the first material into the second material; and obtaining a resulting solution containing the antigen in a second concentration. The second concentration of the antigen in the resulting solution is higher than the first concentration of the antigen in the sample. Numerous other aspects in accordance with this and other embodiments are provided.

First claim

What is claimed is:

1 . A method of increasing a concentration of an antigen of a respiratory virus, comprising:
preparing a sample containing a first concentration of the antigen; contacting the sample containing the first concentration of the antigen to a first material having a negatively-charged surface, thereby capturing an amount of the antigen with the first material; contacting a second material to the first material to transfer the antigen from the first material to the second material, the second material having an ionic strength sufficient to release the captured antigen from the first material into the second material; and obtaining a resulting solution containing the antigen in a second concentration; whereby the second concentration of antigen in the resulting solution is higher than the first concentration of antigen in the sample.

2 . The method of claim 1 , where the sample is saliva or a gargle solution containing saliva.

3 . The method of claim 1 , wherein preparing the sample comprises lysing a SARS-CoV-2 virus contained in the sample with a detergent and increasing a pH of the sample.

4 . The method of claim 1 , wherein the first material is a membrane.

5 . The method of claim 4 , wherein the membrane further comprises a detergent and pH-increasing reagents.

6 . The method of claim 1 , where the first material is a paper.

7 . The method of claim 6 , where the paper further comprises a detergent and pH-increasing reagents.

8 . The method of claim 1 , wherein the first material is a resin.

9 . The method of claim 1 , wherein the second material is a buffer with a high ionic strength.

10 . The method of claim 1 , wherein the sample has a volume that is larger than a volume of the resulting solution.

11 . The method of claim 1 , wherein the antigen is from a coronavirus or an influenza virus.

12 . A kit comprising the first material and the second material, suitable for performing the method of claim 1 .

13 . The kit of claim 12 , further comprising a device selected from the group consisting of a syringe, a plunger and a pipette configured to assist at least one of contact of the sample with the first material and contact of the first material with the second material.

14 . A collection system configured to collect and concentrate an antigen of a respiratory virus, comprising:
a collection device configured to receive a sample of saliva-containing solution of a first volume; a reagent member having one or more reagents configured to contact the sample within the collection device and to lyse the sample so as to release antigen in the sample; a binding medium having a negatively-charged surface configured to contact the lysed sample and bind the antigen in the lysed sample to the negatively-charged surface of the binding medium; and an elution buffer solution of a second volume configured to release the antigen bound to the negatively-charged surface of the binding medium to produce a resulting antigen solution; wherein the second volume is less than the first volume.

15 . The collection system of claim 14 wherein the reagent member includes a reagent configured to increase a pH of the sample.

16 . The collection system of claim 14 wherein the collection device is configured to collect a sample of saliva-containing solution having a first concentration of antigen and the elution buffer solution is configured to release antigen into the elution buffer solution to produce a resulting solution containing the antigen in a second concentration, wherein the second concentration of antigen in the resulting solution is higher than the first concentration of antigen in the sample.

17 . The collection system of claim 14 further comprising a syringe including the binding medium, the syringe configured to couple to the collection device and draw the sample from the collection device through the binding medium so as to bind antigen in the sample to the negatively-charged surface of the binding medium.

18 . The collection system of claim 17 further comprising an elution buffer solution container containing the elution buffer solution, wherein the syringe is configured to couple to the elution buffer solution container and draw elution buffer solution from the elution buffer solution container through the binding medium so as to release antigen into the elution buffer solution.

19 . The collection system of claim 14 further comprising a pipette including the binding medium, the pipette configured to draw the sample from the collection device through the binding medium so as to bind antigen to the negatively-charged surface of the binding medium.

20 . The collection system of claim 19 wherein the pipette includes a first bulb for use during capture of antigen from the sample by the binding medium and a second bulb for use during release of antigen from the binding medium by the elution buffer solution.

21 . The collection system of claim 14 wherein the reagent member and the binding medium are located within the collection device.

22 . The collection system of claim 21 wherein the reagent member comprises one or more dry reagents and wherein the binding medium comprises a plurality of resin structures each having a negatively-charged surface.

23 . The collection system of claim 14 wherein the antigen is from a coronavirus or an influenza virus.

24 .- 50 . (canceled)

Assignees

• Siemens Healthcare Diagnostics Inc

Inventors

• Ledden David
• Mayfield Jeffrey
• Huff Hollie

Classifications

• G01N1/4005 Primary

  by transferring a selected component through a membrane · CPC title

• G01N2001/4038

  electric methods, e.g. electromigration, electrophoresis, ionisation · CPC title

• G01N2001/4011

  being a ion-exchange membrane · CPC title