Your browser doesn't support javascript.
Commercial Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Molecular Assays: Superior Analytical Sensitivity of cobas SARS-CoV-2 Relative to NxTAG CoV Extended Panel and ID NOW COVID-19 Test.
Jin, Run; Pettengill, Matthew A; Hartnett, Nicole L; Auerbach, Herbert E; Peiper, Stephen C; Wang, Zixuan.
  • Jin R; From the Molecular & Genomic Pathology Laboratory, Clinical Laboratories, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania (Jin, Hartnett).
  • Pettengill MA; the Departments of Pathology, Anatomy, & Cell Biology (Pettengill, Peiper, Wang) and Surgery (Wang), Thomas Jefferson University, Philadelphia, Pennsylvania.
  • Hartnett NL; From the Molecular & Genomic Pathology Laboratory, Clinical Laboratories, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania (Jin, Hartnett).
  • Auerbach HE; the Department of Pathology, Abington Memorial Hospital/Abington-Jefferson Health, Philadelphia, Pennsylvania (Auerbach).
  • Peiper SC; the Departments of Pathology, Anatomy, & Cell Biology (Pettengill, Peiper, Wang) and Surgery (Wang), Thomas Jefferson University, Philadelphia, Pennsylvania.
  • Wang Z; the Departments of Pathology, Anatomy, & Cell Biology (Pettengill, Peiper, Wang) and Surgery (Wang), Thomas Jefferson University, Philadelphia, Pennsylvania.
Arch Pathol Lab Med ; 144(11): 1303-1310, 2020 11 01.
Article in English | MEDLINE | ID: covidwho-937676
ABSTRACT
CONTEXT.­ We implemented multiple nucleic acid amplification test platforms because of the limited availability of test kits for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during the early stages of the pandemic. Interpretation of results generated by different platforms and prioritization for testing algorithms required cross-comparison. OBJECTIVE.­ To compare the analytical sensitivity of 3 commercial SARS-CoV-2 molecular assays, selected samples were studied in parallel with Cobas SARS-CoV-2 test, NxTAG CoV Extended Panel, and ID NOW COVID-19 assays. DESIGN.­ A total of 8043 SARS-CoV-2 tests performed from March 22 to April 19, 2020, were included in this study. For all 1794 positive specimens detected by the cobas SARS-CoV-2 assay, the cycle threshold (Ct) values were manually tracked and plotted to demonstrate the distribution of sample viral levels. Additionally, 50 and 63 low-positive specimens (Ct values >32) as well as 50 and 61 consecutive positive specimens by the cobas assay were tested with NxTAG and ID NOW, respectively, to estimate their relative sensitivities. RESULTS.­ The Ct values of cobas SARS-CoV-2-positive samples were evenly distributed throughout ranges of 13.32 to 39.50 (mean, 25.06) and 13.60 to 42.49 (mean, 26.45) for ORF1 and E gene targets, respectively. NxTAG reliably detected only specimens with E gene Ct values lower than 33, and is estimated to detect 89.4% of positive specimens detected by cobas assay. ID NOW had performance variation independent of Ct value and is estimated to detect 83.5% of cobas positives. CONCLUSIONS.­ Clinical specimens exhibit a wide range of viral burden, with a significant portion at low levels. Analytical sensitivity of testing platforms is critical for reliable detection of SARS-CoV-2 and uniform care to patients.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Coronavirus Infections / Nucleic Acid Amplification Techniques / Molecular Diagnostic Techniques / Severe Acute Respiratory Syndrome / SARS Virus / Betacoronavirus Type of study: Diagnostic study / Randomized controlled trials / Screening study Limits: Adult / Female / Humans / Male / Middle aged Language: English Journal: Arch Pathol Lab Med Year: 2020 Document Type: Article

Similar

MEDLINE

...
LILACS

LIS


Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Coronavirus Infections / Nucleic Acid Amplification Techniques / Molecular Diagnostic Techniques / Severe Acute Respiratory Syndrome / SARS Virus / Betacoronavirus Type of study: Diagnostic study / Randomized controlled trials / Screening study Limits: Adult / Female / Humans / Male / Middle aged Language: English Journal: Arch Pathol Lab Med Year: 2020 Document Type: Article