Real-life clinical sensitivity of SARS-CoV-2 RT-PCR test in symptomatic patients

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Kortela , E , Kirjavainen , V , Ahava , M J , Jokiranta , S T , But , A , Lindahl , A , Jääskeläinen , A E , Jääskeläinen , A J , Järvinen , A , Jokela , P , Kallio-Kokko , H , Loginov , R , Mannonen , L , Ruotsalainen , E , Sironen , T , Vapalahti , O , Lappalainen , M , Kreivi , H-R , Jarva , H , Kurkela , S & Kekäläinen , E 2021 , ' Real-life clinical sensitivity of SARS-CoV-2 RT-PCR test in symptomatic patients ' , PLoS One , vol. 16 , no. 5 , 0251661 . https://doi.org/10.1371/journal.pone.0251661

Title: Real-life clinical sensitivity of SARS-CoV-2 RT-PCR test in symptomatic patients
Author: Kortela, Elisa; Kirjavainen, Vesa; Ahava, Maarit J.; Jokiranta, Suvi T.; But, Anna; Lindahl, Anna; Jääskeläinen, Anu E.; Jääskeläinen, Annemarjut J.; Järvinen, Asko; Jokela, Pia; Kallio-Kokko, Hannimari; Loginov, Raisa; Mannonen, Laura; Ruotsalainen, Eeva; Sironen, Tarja; Vapalahti, Olli; Lappalainen, Maija; Kreivi, Hanna-Riikka; Jarva, Hanna; Kurkela, Satu; Kekäläinen, Eliisa
Contributor: University of Helsinki, HUSLAB
University of Helsinki, HUSLAB
University of Helsinki, HUSLAB
University of Helsinki, Medicum
University of Helsinki, Department of Public Health
University of Helsinki, HUS Heart and Lung Center
University of Helsinki, HUSLAB
University of Helsinki, Medicum
University of Helsinki, HUS Inflammation Center
University of Helsinki, HUSLAB
University of Helsinki, HUSLAB
University of Helsinki, HUSLAB
University of Helsinki, Medicum
University of Helsinki, HUS Internal Medicine and Rehabilitation
University of Helsinki, Department of Virology
University of Helsinki, Department of Virology
University of Helsinki, Clinicum
University of Helsinki, HUS Heart and Lung Center
University of Helsinki, Medicum
University of Helsinki, Medicum
University of Helsinki, Medicum
Date: 2021-05-21
Language: eng
Number of pages: 19
Belongs to series: PLoS One
ISSN: 1932-6203
URI: http://hdl.handle.net/10138/333358
Abstract: Background Understanding the false negative rates of SARS-CoV-2 RT-PCR testing is pivotal for the management of the COVID-19 pandemic and it has implications for patient management. Our aim was to determine the real-life clinical sensitivity of SARS-CoV-2 RT-PCR. Methods This population-based retrospective study was conducted in March-April 2020 in the Helsinki Capital Region, Finland. Adults who were clinically suspected of SARS-CoV-2 infection and underwent SARS-CoV-2 RT-PCR testing, with sufficient data in their medical records for grading of clinical suspicion were eligible. In addition to examining the first RT-PCR test of repeat-tested individuals, we also used high clinical suspicion for COVID-19 as the reference standard for calculating the sensitivity of SARS-CoV-2 RT-PCR. Results All 1,194 inpatients (mean [SD] age, 63.2 [18.3] years; 45.2% women) admitted to COVID-19 cohort wards during the study period were included. The outpatient cohort of 1,814 individuals (mean [SD] age, 45.4 [17.2] years; 69.1% women) was sampled from epidemiological line lists by systematic quasi-random sampling. The sensitivity (95% CI) for laboratory confirmed cases (repeat-tested patients) was 85.7% (81.5-89.1%) inpatients; 95.5% (92.2-97.5%) outpatients, 89.9% (88.2-92.1%) all. When also patients that were graded as high suspicion but never tested positive were included in the denominator, the sensitivity (95% CI) was: 67.5% (62.9-71.9%) inpatients; 34.9% (31.4-38.5%) outpatients; 47.3% (44.4-50.3%) all. Conclusions The clinical sensitivity of SARS-CoV-2 RT-PCR testing was only moderate at best. The relatively high false negative rates of SARS-CoV-2 RT-PCR testing need to be accounted for in clinical decision making, epidemiological interpretations, and when using RT-PCR as a reference for other tests.
Subject: 11832 Microbiology and virology
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