Evolution of the false negative rate of RT-PCR for SARS-CoV-2 :
Negative post-test probability of COVID-19 :
- IF : LOW
- retrospective study (-)
- inclusion of two pre-prints (-)
- inaccurate false negative rate due to design heterogeneity of source studies (-)
- Sensitivity analyses in favor of robust results (+)
- probable underestimation of false-negative rate since COVID-19 patients with no positive test are not considered (-)
Literature review and analysis of pooled retrospective data.
Review conducted on PubMed, bioRxiv and medRxiv up to 15/04/2020. Selection of studies :
- with data on the performance of RT-PCR for SARS-CoV-2 as a function of time (from exposure or symptom onset).
- using upper airway samples.
Inclusion of 7 studies: 2 pre-prints and 5 peer-reviewed articles allowing 1330 RT-PCR tests to be counted.
Case definition :
- for most studies: at least one positive RT-PCR test
- for two studies: a few cases not confirmed by test but on clinical criteria with often positive anti-SARS-CoV-2 IgG or IgM.
Statistical analyses: construction of a hierarchical Bayesian logistic regression model with the assumption (based on previous studies) that the onset of infection occurred 5 days before the onset of symptoms. Calculation, for each day after infection, of the expected false-negative rate and the post-test probability of infection. The specificity was considered to be 100% from the literature.
- exclusion of each study in turn
- repeat analyses with 90% lower specificity
- repeat analysis with variation of incubation time between 3 and 7 days
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