tetano
Editor, Senior Moderator
J Clin Microbiol
. 2020 Jun 8;JCM.00995-20.
doi: 10.1128/JCM.00995-20. Online ahead of print.
Clinical Performance of SARS-CoV-2 Molecular Testing
Daniel A Green[SUP] 1 [/SUP], Jason Zucker[SUP] 2 [/SUP], Lars F Westblade[SUP] 3 4 [/SUP], Susan Whittier[SUP] 1 [/SUP], Hanna Rennert[SUP] 3 [/SUP], Priya Velu[SUP] 3 [/SUP], Arryn Craney[SUP] 3 [/SUP], Melissa Cushing[SUP] 3 [/SUP], Dakai Liu[SUP] 5 [/SUP], Magdalena E Sobieszczyk[SUP] 2 [/SUP], Amelia K Boehme[SUP] 6 [/SUP], Jorge L Sepulveda[SUP] 7 [/SUP]
Affiliations
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 3/10/2020-5/1/2020 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 20-30 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 caution when acting on single results. 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 or next 2 days after a negative test in patients with high suspicion for COVID-19.
. 2020 Jun 8;JCM.00995-20.
doi: 10.1128/JCM.00995-20. Online ahead of print.
Clinical Performance of SARS-CoV-2 Molecular Testing
Daniel A Green[SUP] 1 [/SUP], Jason Zucker[SUP] 2 [/SUP], Lars F Westblade[SUP] 3 4 [/SUP], Susan Whittier[SUP] 1 [/SUP], Hanna Rennert[SUP] 3 [/SUP], Priya Velu[SUP] 3 [/SUP], Arryn Craney[SUP] 3 [/SUP], Melissa Cushing[SUP] 3 [/SUP], Dakai Liu[SUP] 5 [/SUP], Magdalena E Sobieszczyk[SUP] 2 [/SUP], Amelia K Boehme[SUP] 6 [/SUP], Jorge L Sepulveda[SUP] 7 [/SUP]
Affiliations
- PMID: 32513858
- DOI: 10.1128/JCM.00995-20
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 3/10/2020-5/1/2020 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 20-30 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 caution when acting on single results. 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 or next 2 days after a negative test in patients with high suspicion for COVID-19.