NATtrol Respiratory Validation Panel (RVP) (Qualitative) (13 X 0.2 mL)

Sensitive, high-throughput molecular detection assays are essential during the coronavirus disease 2019 (COVID-19) pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

The vast majority of SARS-CoV-2 molecular assays use nasopharyngeal swabs (NPS) or oropharyngeal swabs (OPS) collected from suspected individuals. However, using NPS or OPS as probes has obvious disadvantages, e.g. B.

NPS or OPS specimen collection procedures can be uncomfortable for some people and can cause sneezing and coughing, which in turn creates droplets and/or aerosol particles that pose a risk to medical workers who require extensive use of personal protective equipment. There are recent studies suggesting that self-collected saliva samples can be used for molecular detection of SARS-CoV-2, offering more convenience and ease of use to patients. Here we report the performance of QuantiVirus ^™  SARS-CoV-2 Test using saliva as test samples with or without pooling.

methods

Development and validation studies were conducted in accordance with FDA EUA and molecular assay validation guidelines. Using the SeraCare Accuplex SARS-CoV-2 reference panel, limit of detection (LOD) and clinical performance studies were performed with the QuantiVirus SARS-CoV-2 test. For the clinical evaluation, 85 known positive and 90 known negative NPS clinical specimens were tested. In addition, twenty paired NPS and saliva samples from recovering COVID-19 patients were tested and the results were further compared to those of the Abbott m2000 SARS-CoV-2 PCR assay. The results of 389 from theCommunity collected saliva samples for COVID-19 screening using the QuantiVirus SARS-CoV-2 test were also obtained and analyzed. In addition, testing of pooled saliva samples was evaluated.

Preliminary data showed that pooling of saliva samples from up to 6 samples (1:6 pooling) for SARS-CoV-2 detection is feasible (sensitivity 94.8% and specificity 100%)

Results

The LOD for the QuantiVirus SARS-CoV-2 test has been confirmed to be 100-200 copies/mL. The clinical performance studies using artificial saliva samples showed that the positive percentage agreement (PPA) of the QuantiVirus SARS-CoV-2 test is 100% at 1xLOD, 1.5xLOD and 2.5xLOD. ^{No cross-reactivity with common respiratory pathogens was observed for the QuantiVirus}  SARS-CoV-2 test. Testing of clinical samples showed a positive percent agreement (PPA) of 100% (95% CI: 94.6% to 100%) and a negative percent agreement (NPA) of 98.9% (95% CI: 93.1). % to 99.9%). The QuantiVirus  ^™  SARS CoV-2 test had an 80% agreement rate and no significant difference (  p= 0.13) between paired saliva and NPS samples by Wilcoxon Matched Pairs Signed Rank Test. The positive test rate was 1.79% for 389 saliva samples collected from local communities for COVID-19 screening. .

Conclusion

The studies showed that the QuantiVirus SARS-CoV-2 test has a LOD of 200 copies/mL in artificial saliva samples. The clinical performance of saliva-based tests is comparable to that of NPS-based tests. Pooling of saliva samples for SARS-CoV-2 detection is possible. The saliva-based and high-throughput QuantiVirus SARS-CoV-2 test provides a highly desirable testing platform during the ongoing COVID-19 pandemic.