US 11,530,457 B2 · Saliva-based molecular testing for SARS-CoV-2

Abstract

A saliva-based testing method that bypasses the need for RNA isolation/purification is described herein. In experiments with inactivated SARS-CoV-2 virus spiked into saliva, this method has a limit of detection of 500-1000 viral particles per mL, rivalling the standard NP swab method. Initial studies showed excellent performance with 100 clinical samples. This saliva-based process is operationally simple, utilizes readily available materials, and can be easily implemented by existing testing sites thus allowing for high-throughput, rapid, and repeat testing of large populations.

Claims4

Dependent claims

A method of detecting viral polynucleotides in a saliva sample comprising:

combining the saliva sample with Tris Borate Ethylenediaminetetraacetic acid (TBE) at about a 1:3 w/w to about 3:1 w/w ratio prior to heating the saliva sample, to form a mixture;
heating the mixture at about 95 degrees Celsius for about 15 minutes to about 30 minutes;
after heating, contacting the heated mixture with one or more non-ionic detergents, wherein the one or more non-ionic detergents are present in a final concentration of about 0.25% to about 1% by weight to provide a test sample;
and
subjecting the test sample to conditions that amplify target viral polynucleotides in the test sample using RT-qPCR, and detecting the viral polynucleotides in the biological sample.

2 more elements

Dependencies are inferred from the claim text.

Facts

Application

17/636,469Filed 17 Jun 2021 · us provisional application

Priority

18 Jun 2020

Published

US 2022/0275464 A11 Sep 2022

Granted

20 Dec 2022

Term ends

Not estimatedThe source records don’t support an estimate.

Classification4 codes

C12Q 1/70
Measuring or testing processes involving enzymes, nucleic acids or microorganisms ; Compositions therefor; Processes of preparing such…
C12Q 1/701
Involving virus or bacteriophage: specific hybridization probes
C12Q 2600/158
Oligonucleotides characterized by their use: expression markers
C12Q
Measuring or testing processes involving enzymes, nucleic acids or microorganisms

Saliva-based molecular testing for SARS-CoV-2

Life of this patent

Saliva-based molecular testing for SARS-CoV-2

Life of this patent

Abstract

Claims4