Impact of COVID-19 pre-test probability on positive predictive value of high cycle threshold SARS-CoV-2 real-time reverse transcription PCR test results
| Autor: | Roberto G. Melano, Jonathan B. Gubbay, Romy Olsha, Tony Mazzulli, Liane Macdonald, Julianne V. Kus, Erik Kristjanson, Jessica Hopkins, Jessica D. Forbes, Gustavo V. Mallo, Nahuel Fittipaldi, Heather L. Kristjanson, Antoine Corbeil, Vanessa Tran, Vanessa Allen, Stephen Perusini, Alireza Eshaghi, Michelle Murti, George Broukhanski, Heather Rilkoff, Samir N. Patel, Anna Majury |
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| Rok vydání: | 2021 |
| Předmět: |
Sanger sequencing
medicine.medical_specialty business.industry Prevalence Context (language use) Asymptomatic Pre- and post-test probability Reverse transcription polymerase chain reaction symbols.namesake Internal medicine Epidemiology medicine False positive paradox symbols medicine.symptom business |
| DOI: | 10.1101/2021.03.02.21252768 |
| Popis: | BackgroundPerformance characteristics of SARS-CoV-2 nucleic acid detection assays are understudied within contexts of low pre-test probability, including screening asymptomatic persons without epidemiological links to confirmed cases, or asymptomatic surveillance testing. SARS-CoV-2 detection without symptoms may represent resolved infection with persistent RNA shedding, presymptomatic or asymptomatic infection, or a false positive test. This study assessed clinical specificity of SARS-CoV-2 real-time reverse transcription polymerase chain reaction (rRT-PCR) assays by retesting positive specimens from five pre-test probability groups ranging from high to low with an alternate assay.Materials and MethodsA total of 122 rRT-PCR positive specimens collected from unique patients between March and July 2020 were retested using a laboratory-developed nested RT-PCR assay targeting the RNA-dependent RNA polymerase (RdRp) gene followed by Sanger sequencing.ResultsSignificantly less positive results in the lowest pre-test probability group (facilities with institution-wide screening having ≤ 3 positive asymptomatic cases) were reproduced with the nested RdRp gene RT-PCR assay than in all other groups combined (5/32, 15·6% vs 61/90, 68%; p ConclusionsA higher proportion of false-positive test results are likely with lower pre-test probability. Positive SARS-CoV-2 PCR results should be interpreted within the context of patient history, clinical setting, known exposure, and estimated community disease prevalence. Large-scale SARS-CoV-2 screening testing initiatives among low pre-test probability populations should be evaluated thoroughly prior to implementation given the risk of false positives and consequent potential for harm at the individual and population level. |
| Databáze: | OpenAIRE |
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