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Clinical Performance of SARS-CoV-2 Molecular Tests.
J Clin Microbiol. 2020 Jul 23; 58(8)JC

Abstract

Molecular testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the gold standard for diagnosis of coronavirus disease 2019 (COVID-19), but the clinical performance of these tests is still poorly understood, particularly with regard to disease course, patient-specific factors, and viral shedding. From 10 March to 1 May 2020, NewYork-Presbyterian laboratories performed 27,377 SARS-CoV-2 molecular assays from 22,338 patients. Repeat testing was performed for 3,432 patients, of which 2,413 had initial negative and 802 had initial positive results. Repeat-tested patients were more likely to have severe disease and low viral loads. The negative predictive value of the first-day result among repeat-tested patients was 81.3% The clinical sensitivity of SARS-CoV-2 molecular assays was estimated between 58% and 96%, depending on the unknown number of false-negative results in single-tested patients. Conversion to negative was unlikely to occur before 15 to 20 days after initial testing or 20 to 30 days after the onset of symptoms, with 50% conversion occurring at 28 days after initial testing. Conversion from first-day negative to positive results increased linearly with each day of testing, reaching 25% probability in 20 days. Sixty patients fluctuated between positive and negative results over several weeks, suggesting that caution is needed when single-test results are acted upon. In summary, our study provides estimates of the clinical performance of SARS-CoV-2 molecular assays and suggests time frames for appropriate repeat testing, namely, 15 to 20 days after a positive test and the same day or next 2 days after a negative test for patients with high suspicion for COVID-19.

Authors+Show Affiliations

Department of Pathology & Cell Biology, Columbia University Irving Medical Center, New York, New York, USA.Division of Infectious Diseases, Department of Internal Medicine, Columbia University Irving Medical Center, New York, New York, USA.Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, New York, USA. Division of Infectious Diseases, Department of Medicine, Weill Cornell Medicine, New York, New York, USA.Department of Pathology & Cell Biology, Columbia University Irving Medical Center, New York, New York, USA.Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, New York, USA.Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, New York, USA.Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, New York, USA.Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, New York, USA.Department of Pathology and Clinical Laboratories, NewYork-Presbyterian Queens Hospital, Queens, New York, USA.Division of Infectious Diseases, Department of Internal Medicine, Columbia University Irving Medical Center, New York, New York, USA.Department of Epidemiology and Neurology, Columbia University Irving Medical Center, New York, New York, USA.Department of Pathology & Cell Biology, Columbia University Irving Medical Center, New York, New York, USA jls2282@cumc.columbia.edu.

Pub Type(s)

Journal Article
Observational Study

Language

eng

PubMed ID

32513858

Citation

Green, Daniel A., et al. "Clinical Performance of SARS-CoV-2 Molecular Tests." Journal of Clinical Microbiology, vol. 58, no. 8, 2020.
Green DA, Zucker J, Westblade LF, et al. Clinical Performance of SARS-CoV-2 Molecular Tests. J Clin Microbiol. 2020;58(8).
Green, D. A., Zucker, J., Westblade, L. F., Whittier, S., Rennert, H., Velu, P., Craney, A., Cushing, M., Liu, D., Sobieszczyk, M. E., Boehme, A. K., & Sepulveda, J. L. (2020). Clinical Performance of SARS-CoV-2 Molecular Tests. Journal of Clinical Microbiology, 58(8). https://doi.org/10.1128/JCM.00995-20
Green DA, et al. Clinical Performance of SARS-CoV-2 Molecular Tests. J Clin Microbiol. 2020 Jul 23;58(8) PubMed PMID: 32513858.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical Performance of SARS-CoV-2 Molecular Tests. AU - Green,Daniel A, AU - Zucker,Jason, AU - Westblade,Lars F, AU - Whittier,Susan, AU - Rennert,Hanna, AU - Velu,Priya, AU - Craney,Arryn, AU - Cushing,Melissa, AU - Liu,Dakai, AU - Sobieszczyk,Magdalena E, AU - Boehme,Amelia K, AU - Sepulveda,Jorge L, Y1 - 2020/07/23/ PY - 2020/05/04/received PY - 2020/06/05/accepted PY - 2020/6/10/pubmed PY - 2020/8/5/medline PY - 2020/6/10/entrez KW - COVID-19 KW - SARS-CoV-2 KW - laboratory utilization KW - negative predictive value KW - sensitivity JF - Journal of clinical microbiology JO - J Clin Microbiol VL - 58 IS - 8 N2 - Molecular testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the gold standard for diagnosis of coronavirus disease 2019 (COVID-19), but the clinical performance of these tests is still poorly understood, particularly with regard to disease course, patient-specific factors, and viral shedding. From 10 March to 1 May 2020, NewYork-Presbyterian laboratories performed 27,377 SARS-CoV-2 molecular assays from 22,338 patients. Repeat testing was performed for 3,432 patients, of which 2,413 had initial negative and 802 had initial positive results. Repeat-tested patients were more likely to have severe disease and low viral loads. The negative predictive value of the first-day result among repeat-tested patients was 81.3% The clinical sensitivity of SARS-CoV-2 molecular assays was estimated between 58% and 96%, depending on the unknown number of false-negative results in single-tested patients. Conversion to negative was unlikely to occur before 15 to 20 days after initial testing or 20 to 30 days after the onset of symptoms, with 50% conversion occurring at 28 days after initial testing. Conversion from first-day negative to positive results increased linearly with each day of testing, reaching 25% probability in 20 days. Sixty patients fluctuated between positive and negative results over several weeks, suggesting that caution is needed when single-test results are acted upon. In summary, our study provides estimates of the clinical performance of SARS-CoV-2 molecular assays and suggests time frames for appropriate repeat testing, namely, 15 to 20 days after a positive test and the same day or next 2 days after a negative test for patients with high suspicion for COVID-19. SN - 1098-660X UR - https://www.unboundmedicine.com/medline/citation/32513858/Clinical_Performance_of_SARS_CoV_2_Molecular_Tests_ L2 - http://jcm.asm.org/cgi/pmidlookup?view=long&pmid=32513858 DB - PRIME DP - Unbound Medicine ER -