Fig 1.
(A) SARS-CoV-2 genome structure and assay target genes. Republished from FDA EUA [14] under a CC BY license, with permission from Diacarta Inc, original copyright [2020]. (B) a high throughput workflow for SARS-COV-2 detection from sample collection to result availability within about 4 hrs.
Table 1.
a. Results of twenty replicates for analytical sensitivity confirmation on the ABI 7500 Dx. b. Results of twenty replicates for analytical sensitivity confirmation on the BioRad CFX 384. c. Results of twenty replicates for analytical sensitivity confirmation on the Roche LC 480. d. Results of twenty replicates for analytical sensitivity confirmation on the ABI QS5.
Table 2.
Results of clinical NPS sample evaluation using QuantiVirus™ SARS-CoV-2 test.
Fig 2.
Clinical evaluation of paired nasopharyngeal and saliva samples.
Cycle threshold (Ct) values for target gene and RP gene of NPS and saliva specimens were compared by Wilcoxon matched pairs signed rank test. Cycle threshold (Ct) values for viral E gene, N gene, O gene (ORF1ab), and human RNase P gene (RP) for NP and saliva specimens. A) E, N, and O Ct values for paired NP and saliva samples. Pairs are connected by a line. The Ct was set to 42 for samples in which signal was not detected. Ct values of E, N, and O were comparable between the two types of samples by Wilcoxon signed rank test. NPS and saliva concordance is about 80% with no significant differences (p = 0.13). B) RP Ct values for NP and saliva specimens were similar between the two types of samples by Wilcoxon signed rank test.
Table 3.
Comparison of Abbott m2000 SARS-CoV-2 PCR test and DiaCarta QuantiVirus™ SARS-CoV-2 PCR test for SARS-CoV-2 detection in clinical saliva samples.
Table 4.
Summary of saliva-based COVID-19 screening using QuantiVirus™ SARS-CoV-2 test in local communities.
Table 5.
Saliva sample pooling for SARS-CoV-2 detection by QuantiVirus™ SARS-COV-2 test kit.