Real-life clinical sensitivity of SARS-CoV-2 RT-PCR test in symptomatic patients.
<h4>Background</h4>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.<h4>Methods...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2021-01-01
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| Series: | PLoS ONE |
| Online Access: | https://doi.org/10.1371/journal.pone.0251661 |
| _version_ | 1818899739711635456 |
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| author | Elisa Kortela Vesa Kirjavainen Maarit J Ahava Suvi T Jokiranta Anna But Anna Lindahl Anu E Jääskeläinen Annemarjut J Jääskeläinen Asko Järvinen Pia Jokela Hannimari Kallio-Kokko Raisa Loginov Laura Mannonen Eeva Ruotsalainen Tarja Sironen Olli Vapalahti Maija Lappalainen Hanna-Riikka Kreivi Hanna Jarva Satu Kurkela Eliisa Kekäläinen |
| author_facet | Elisa Kortela Vesa Kirjavainen Maarit J Ahava Suvi T Jokiranta Anna But Anna Lindahl Anu E Jääskeläinen Annemarjut J Jääskeläinen Asko Järvinen Pia Jokela Hannimari Kallio-Kokko Raisa Loginov Laura Mannonen Eeva Ruotsalainen Tarja Sironen Olli Vapalahti Maija Lappalainen Hanna-Riikka Kreivi Hanna Jarva Satu Kurkela Eliisa Kekäläinen |
| author_sort | Elisa Kortela |
| collection | DOAJ |
| description | <h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusions</h4>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. |
| first_indexed | 2024-12-19T19:52:45Z |
| format | Article |
| id | doaj.art-ec5a0708349a4766a25940e2043eed5a |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-12-19T19:52:45Z |
| publishDate | 2021-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-ec5a0708349a4766a25940e2043eed5a2022-12-21T20:07:55ZengPublic Library of Science (PLoS)PLoS ONE1932-62032021-01-01165e025166110.1371/journal.pone.0251661Real-life clinical sensitivity of SARS-CoV-2 RT-PCR test in symptomatic patients.Elisa KortelaVesa KirjavainenMaarit J AhavaSuvi T JokirantaAnna ButAnna LindahlAnu E JääskeläinenAnnemarjut J JääskeläinenAsko JärvinenPia JokelaHannimari Kallio-KokkoRaisa LoginovLaura MannonenEeva RuotsalainenTarja SironenOlli VapalahtiMaija LappalainenHanna-Riikka KreiviHanna JarvaSatu KurkelaEliisa Kekäläinen<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusions</h4>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.https://doi.org/10.1371/journal.pone.0251661 |
| spellingShingle | Elisa Kortela Vesa Kirjavainen Maarit J Ahava Suvi T Jokiranta Anna But Anna Lindahl Anu E Jääskeläinen Annemarjut J Jääskeläinen Asko Järvinen Pia Jokela Hannimari Kallio-Kokko Raisa Loginov Laura Mannonen Eeva Ruotsalainen Tarja Sironen Olli Vapalahti Maija Lappalainen Hanna-Riikka Kreivi Hanna Jarva Satu Kurkela Eliisa Kekäläinen Real-life clinical sensitivity of SARS-CoV-2 RT-PCR test in symptomatic patients. PLoS ONE |
| title | Real-life clinical sensitivity of SARS-CoV-2 RT-PCR test in symptomatic patients. |
| title_full | Real-life clinical sensitivity of SARS-CoV-2 RT-PCR test in symptomatic patients. |
| title_fullStr | Real-life clinical sensitivity of SARS-CoV-2 RT-PCR test in symptomatic patients. |
| title_full_unstemmed | Real-life clinical sensitivity of SARS-CoV-2 RT-PCR test in symptomatic patients. |
| title_short | Real-life clinical sensitivity of SARS-CoV-2 RT-PCR test in symptomatic patients. |
| title_sort | real life clinical sensitivity of sars cov 2 rt pcr test in symptomatic patients |
| url | https://doi.org/10.1371/journal.pone.0251661 |
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