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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.
Arch Pathol Lab Med. 2020 11 01; 144(11):1303-1310.AP

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.

Authors+Show Affiliations

From the Molecular & Genomic Pathology Laboratory, Clinical Laboratories, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania (Jin, Hartnett).the Departments of Pathology, Anatomy, & Cell Biology (Pettengill, Peiper, Wang) and Surgery (Wang), Thomas Jefferson University, Philadelphia, Pennsylvania.From the Molecular & Genomic Pathology Laboratory, Clinical Laboratories, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania (Jin, Hartnett).the Department of Pathology, Abington Memorial Hospital/Abington-Jefferson Health, Philadelphia, Pennsylvania (Auerbach).the Departments of Pathology, Anatomy, & Cell Biology (Pettengill, Peiper, Wang) and Surgery (Wang), Thomas Jefferson University, Philadelphia, Pennsylvania.the Departments of Pathology, Anatomy, & Cell Biology (Pettengill, Peiper, Wang) and Surgery (Wang), Thomas Jefferson University, Philadelphia, Pennsylvania.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32649229

Citation

Jin, Run, et al. "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." Archives of Pathology & Laboratory Medicine, vol. 144, no. 11, 2020, pp. 1303-1310.
Jin R, Pettengill MA, Hartnett NL, et al. 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. Arch Pathol Lab Med. 2020;144(11):1303-1310.
Jin, R., Pettengill, M. A., Hartnett, N. L., Auerbach, H. E., Peiper, S. C., & Wang, Z. (2020). 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. Archives of Pathology & Laboratory Medicine, 144(11), 1303-1310. https://doi.org/10.5858/arpa.2020-0283-SA
Jin R, et al. 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. Arch Pathol Lab Med. 2020 11 1;144(11):1303-1310. PubMed PMID: 32649229.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Jin,Run, AU - Pettengill,Matthew A, AU - Hartnett,Nicole L, AU - Auerbach,Herbert E, AU - Peiper,Stephen C, AU - Wang,Zixuan, PY - 2020/07/07/accepted PY - 2020/7/11/pubmed PY - 2020/11/18/medline PY - 2020/7/11/entrez SP - 1303 EP - 1310 JF - Archives of pathology & laboratory medicine JO - Arch Pathol Lab Med VL - 144 IS - 11 N2 - 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. SN - 1543-2165 UR - https://www.unboundmedicine.com/medline/citation/32649229/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_ L2 - https://meridian.allenpress.com/aplm/article-lookup/doi/10.5858/arpa.2020-0283-SA DB - PRIME DP - Unbound Medicine ER -