A single-step nucleic acid amplification-based assay for the detection of SARS-CoV-2 RNA in saliva is a proposed alternative to conventional RT-qPCR-based diagnostic tests.
We have developed a sample buffer (consisting of a modified RNA stabilisation buffer, the RNA inhibitor Rnasecure, and a polymeric chelator, Chelex100) for the stabilisation of viral RNA and a sampling method that is fast and simple. The main advantage of the method is that it does not require a nasopharyngeal swab, which is invasive to take and requires the assistance of medical staff, but the detection of nucleic acids is performed in a saliva sample, which can be taken by the patient. Another improvement that reduces sample processing time is that the time-consuming step of extracting the viral RNA from the sample before amplification is not necessary, the sample is simply heated to 95 °C after collection and then added to the reaction mixture.
The method is efficient, cost-effective and fast. It is compatible with one-step RT-PCR and achieves 93% agreement with clinical results and 100% specificity. In addition, sample preparation methods can be combined with other nucleic acid amplification methods (e.g. loop-mediated isothermal amplification), but with lower clinical sensitivity.
- Efficient, cost-effective and fast method.
- 93% agreement with clinical results and 100% specificity.
- Can be combined with other nucleic acid amplification methods (e.g. loop-mediated isothermal amplification), but with lower clinical sensitivity.
Fields of use: Biotechnology, Diagnostic tests
Technology Readiness Level: TRL8
Intellectual property: Patent pending
Partner sought: R&D collaboration to further develop the technology, licensing or sell of IP rights.
Next steps needed: Partner search for product development