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 .

Titel: Real-life clinical sensitivity of SARS-CoV-2 RT-PCR test in symptomatic patients
Författare: 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
Upphovmannens organisation: HUSLAB
HUS Inflammation Center
University of Helsinki
HUS Diagnostic Center
TRIMM - Translational Immunology Research Program
Department of Bacteriology and Immunology
Department of Public Health
HUS Heart and Lung Center
Viral Zoonosis Research Unit
Department of Virology
Department of Medicine
Faculty Common Matters
Mirja Puolakkainen / Principal Investigator
HUS Internal Medicine and Rehabilitation
Helsinki One Health (HOH)
Emerging Infections Research Group
Veterinary Biosciences
Olli Pekka Vapalahti / Principal Investigator
Veterinary Microbiology and Epidemiology
Research Programs Unit
Datum: 2021-05-21
Språk: eng
Sidantal: 19
Tillhör serie: PLoS One
ISSN: 1932-6203
Permanenta länken (URI):
Abstrakt: 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
Referentgranskad: Ja
Licens: cc_by
Användningsbegränsning: openAccess
Parallelpublicerad version: publishedVersion

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