Key result
The dual-target cobas SARS-CoV-2 RT-PCR test demonstrated a limit of detection of 0.004 to 0.007 TCID50/mL for the USA-WA1/2020 strain and high precision with Ct coefficients of variation between 1.1 and 2.2%.
Why the study?
Diagnostic testing is essential for the management of the COVID-19 pandemic.
The cobas SARS-CoV-2 RT-PCR test demonstrates high analytical sensitivity, precision, and broad inclusivity for known variants, supporting its use for high-throughput COVID-19 diagnostic testing.
Answers are grounded in this paper and cite their sources.
Facilitates rapid SARS-CoV-2 assay adaptation to variants; leaves open large-scale clinical validation before routine use.
Diagnostic testing is essential for management of the COVID-19 pandemic. An agile assay design methodology, optimized for the cobas ® 6800/8800 system, was used to develop a dual-target, qualitative SARS-CoV-2 RT-PCR test using commercially available reagents and existing sample processing and thermocycling profiles. The limit of detection was 0.004 to 0.007 TCID 50 /mL for USA-WA1/2020. Assay sensitivity was confirmed for SARS-CoV-2 variants Alpha, Beta, Gamma, Delta and Kappa. The coefficients of variation of the cycle threshold number (Ct) were between 1.1 and 2.2%. There was no difference in Ct using nasopharyngeal compared to oropharyngeal swabs in universal transport medium (UTM). A small increase in Ct was observed with specimens collected in cobas ® PCR medium compared to UTM. In silico analysis indicated that the dual-target test is capable of detecting all >1,800,000 SARS-CoV-2 sequences in the GISAID database. Our agile assay design approach facilitated rapid development and deployment of this SARS-CoV-2 RT-PCR test.
No takes yet. Share an insight, caveat, or question.
Manohar et al. (2021) studied COVID-19 (SARS-CoV-2 infection). cobas SARS-CoV-2 RT-PCR test was evaluated on Limit of detection (LoD). The dual-target cobas SARS-CoV-2 RT-PCR test demonstrated a limit of detection of 0.004 to 0.007 TCID50/mL for the USA-WA1/2020 strain and high precision with Ct coefficients of variation between 1.1 and 2.2%.
Synapse has enriched 8 closely related papers on similar clinical questions. Consider them for comparative context: