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

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dc.contributor.author Kortela, Elisa
dc.contributor.author Kirjavainen, Vesa
dc.contributor.author Ahava, Maarit J.
dc.contributor.author Jokiranta, Suvi T.
dc.contributor.author But, Anna
dc.contributor.author Lindahl, Anna
dc.contributor.author Jääskeläinen, Anu E.
dc.contributor.author Jääskeläinen, Annemarjut J.
dc.contributor.author Järvinen, Asko
dc.contributor.author Jokela, Pia
dc.contributor.author Kallio-Kokko, Hannimari
dc.contributor.author Loginov, Raisa
dc.contributor.author Mannonen, Laura
dc.contributor.author Ruotsalainen, Eeva
dc.contributor.author Sironen, Tarja
dc.contributor.author Vapalahti, Olli
dc.contributor.author Lappalainen, Maija
dc.contributor.author Kreivi, Hanna-Riikka
dc.contributor.author Jarva, Hanna
dc.contributor.author Kurkela, Satu
dc.contributor.author Kekäläinen, Eliisa
dc.date.accessioned 2021-08-20T10:30:02Z
dc.date.available 2021-08-20T10:30:02Z
dc.date.issued 2021-05-21
dc.identifier.citation 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
dc.identifier.other PURE: 167354588
dc.identifier.other PURE UUID: 23c50057-7622-45cf-af91-c6e598a63844
dc.identifier.other WOS: 000664632300029
dc.identifier.other ORCID: /0000-0001-6045-108X/work/98749490
dc.identifier.other ORCID: /0000-0002-2344-2755/work/98749939
dc.identifier.other ORCID: /0000-0003-2270-6824/work/98749961
dc.identifier.other ORCID: /0000-0001-5400-1250/work/98750048
dc.identifier.other ORCID: /0000-0001-6653-3238/work/98752451
dc.identifier.uri http://hdl.handle.net/10138/333358
dc.description.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. en
dc.format.extent 19
dc.language.iso eng
dc.relation.ispartof PLoS One
dc.rights cc_by
dc.rights.uri info:eu-repo/semantics/openAccess
dc.subject 11832 Microbiology and virology
dc.title Real-life clinical sensitivity of SARS-CoV-2 RT-PCR test in symptomatic patients en
dc.type Article
dc.contributor.organization HUSLAB
dc.contributor.organization HUS Inflammation Center
dc.contributor.organization University of Helsinki
dc.contributor.organization Clinicum
dc.contributor.organization HUS Diagnostic Center
dc.contributor.organization Medicum
dc.contributor.organization TRIMM - Translational Immunology Research Program
dc.contributor.organization Department of Bacteriology and Immunology
dc.contributor.organization Department of Public Health
dc.contributor.organization HUS Heart and Lung Center
dc.contributor.organization Viral Zoonosis Research Unit
dc.contributor.organization Department of Virology
dc.contributor.organization Department of Medicine
dc.contributor.organization Faculty Common Matters
dc.contributor.organization Mirja Puolakkainen / Principal Investigator
dc.contributor.organization HUS Internal Medicine and Rehabilitation
dc.contributor.organization Helsinki One Health (HOH)
dc.contributor.organization Emerging Infections Research Group
dc.contributor.organization Veterinary Biosciences
dc.contributor.organization Olli Pekka Vapalahti / Principal Investigator
dc.contributor.organization Veterinary Microbiology and Epidemiology
dc.contributor.organization Research Programs Unit
dc.description.reviewstatus Peer reviewed
dc.relation.doi https://doi.org/10.1371/journal.pone.0251661
dc.relation.issn 1932-6203
dc.rights.accesslevel openAccess
dc.type.version publishedVersion

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