We focused on the sensitivity of the first SARS-CoV-2 RT-PCR test since for outpatients repeated testing is not often feasible. We used manually curated clinical characteristics from a cohort of 3,008 individuals as the gold standard for the RT-PCR test. To avoid bias created by the high pretest probability of inpatients, we included in our analysis also outpatients. We decided to evaluate the clinical sensitivity of SARS-CoV-2 RT-PCR in a population-based setting in the beginning of the epidemic with low level of transmission. Real-life sensitivity estimates in the initial reports were limited by small sample sizes and variable testing methods and reference standards. Removal of infection control precautions in hospitalized patients due to a false negative test causes an occupational hazard for healthcare workers and can lead to nosocomial spread of the disease. High false negative rate complicates controlling the epidemic but it also has implications for healthcare settings. Variation in viral shedding in different anatomical locations, and temporal variation in relation to disease onset can influence detection rates. Preanalytical pitfalls such as suboptimal specimen collection may affect sample quality and hamper test sensitivity.
Ī number of pivotal factors may decrease the overall sensitivity of testing and its usefulness in the TTI strategy. networked dynamic metapopulation models, and repeat-testing of patients. However, reports suggest that clinically evident COVID-19 infections often go undetected by SARS-CoV-2 RT-PCR testing, as estimated by e.g. Evidence suggests a fair analytical sensitivity for the SARS-CoV-2 RT-PCR tests available on the market. A key feature of any laboratory test is its efficacy in detecting true positive cases. This does not alter our adherence to PLOS ONE policies on sharing data and materials.ĭuring the COVID-19 pandemic a central method for limiting the spread of SARS-CoV-2 has been the so-called “Test, Trace, Isolate” (TTI) approach promoted by the World Health Organization. Kekäläinen reports a lecture honorarium from MSD. Järvinen reports lecture honoraria from Astellas, OrionPharma, Pfizer, MSD, Sanofi and UnimedicPharma and consultation fee from CSL Behring outside the submitted manuscript. Kortela reports non-financial support from MSD, outside the submitted work. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.Ĭompeting interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Dr. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.ĭata Availability: All relevant data are within the paper and its files.įunding: This work was supported by Academy of Finland (ELKE, grant no 308913) and Doctoral Programme in Biomedicine, Faculty of Medicine, University of Helsinki (SJ). Received: NovemAccepted: ApPublished: May 21, 2021Ĭopyright: © 2021 Kortela et al. PLoS ONE 16(5):Įditor: Silvia Ricci, Meyer Children’s University Hospital - University of Florence, ITALY (2021) Real-life clinical sensitivity of SARS-CoV-2 RT-PCR test in symptomatic patients. Citation: Kortela E, Kirjavainen V, Ahava MJ, Jokiranta ST, But A, Lindahl A, et al.
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