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Clinical Performance of SARS-CoV-2 Molecular Tests.
Green, Daniel A; Zucker, Jason; Westblade, Lars F; Whittier, Susan; Rennert, Hanna; Velu, Priya; Craney, Arryn; Cushing, Melissa; Liu, Dakai; Sobieszczyk, Magdalena E; Boehme, Amelia K; Sepulveda, Jorge L.
  • Green DA; Department of Pathology & Cell Biology, Columbia University Irving Medical Center, New York, New York, USA.
  • Zucker J; Division of Infectious Diseases, Department of Internal Medicine, Columbia University Irving Medical Center, New York, New York, USA.
  • Westblade LF; Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, New York, USA.
  • Whittier S; Division of Infectious Diseases, Department of Medicine, Weill Cornell Medicine, New York, New York, USA.
  • Rennert H; Department of Pathology & Cell Biology, Columbia University Irving Medical Center, New York, New York, USA.
  • Velu P; Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, New York, USA.
  • Craney A; Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, New York, USA.
  • Cushing M; Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, New York, USA.
  • Liu D; Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, New York, USA.
  • Sobieszczyk ME; Department of Pathology and Clinical Laboratories, NewYork-Presbyterian Queens Hospital, Queens, New York, USA.
  • Boehme AK; Division of Infectious Diseases, Department of Internal Medicine, Columbia University Irving Medical Center, New York, New York, USA.
  • Sepulveda JL; Department of Epidemiology and Neurology, Columbia University Irving Medical Center, New York, New York, USA.
J Clin Microbiol ; 58(8)2020 Jul 23.
Article in English | MEDLINE | ID: covidwho-999207
Preprint
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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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Coronavirus Infections / Clinical Laboratory Techniques / Diagnostic Tests, Routine / Betacoronavirus Type of study: Diagnostic study / Experimental Studies / Prognostic study Limits: Adolescent / Adult / Aged / Child / Child, preschool / Female / Humans / Infant / Male / Middle aged Country/Region as subject: North America Language: English Year: 2020 Document Type: Article Affiliation country: JCM.00995-20

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Coronavirus Infections / Clinical Laboratory Techniques / Diagnostic Tests, Routine / Betacoronavirus Type of study: Diagnostic study / Experimental Studies / Prognostic study Limits: Adolescent / Adult / Aged / Child / Child, preschool / Female / Humans / Infant / Male / Middle aged Country/Region as subject: North America Language: English Year: 2020 Document Type: Article Affiliation country: JCM.00995-20