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Serological tests to detect antibodies against SARS-CoV-2 could improve the diagnosis of COVID-19 and be useful tools for epidemiological surveillance. The number of serological tests has rapidly increased, and many are being marketed for point-of-care use. The evidence base supporting the diagnostic accuracy of these tests, however, has not been formally evaluated.
The available evidence on the accuracy of serological tests for COVID-19 is characterized by risks of bias and heterogeneity, and, as such, estimates of sensitivity and specificity are unreliable and have limited generalizability. Evidence is particularly weak for point-of-care serological tests. Caution is warranted if using serological tests for COVID-19 for clinical decision-making or epidemiological surveillance. Current evidence does not support the continued use of existing point-of-care tests.
– Michael Allen, MD
This abstract is available on the publisher's site.
We reviewed the diagnostic accuracy of SARS-CoV-2 serological tests. Random-effects models yielded a summary sensitivity of 82% for IgM, and 85% for IgG and total antibodies. For specificity, the pooled estimate were 98% for IgM and 99% for IgG and total antibodies. In populations with ≤ 5% of seroconverted individuals, unless the assays have perfect (i.e. 100%) specificity, the positive predictive value would be ≤ 88%. Serological tests should be used for prevalence surveys only in hard-hit areas.