No test gives a 100% accurate result; tests need to be evaluated to determine their sensitivity and specificity, ideally by comparison with a “gold standard.” The lack of such a clear-cut “gold-standard” for covid-19 testing makes evaluation of test accuracy challenging.
A systematic review of the accuracy of covid-19 tests reported false negative rates of between 2% and 29% (equating to sensitivity of 71-98%), based on negative RT-PCR tests which were positive on repeat testing. The use of repeat RT-PCR testing as gold standard is likely to underestimate the true rate of false negatives, as not all patients in the included studies received repeat testing and those with clinically diagnosed covid-19 were not considered as actually having covid-19.
Further evidence and independent validation of covid-19 tests are needed. As current studies show marked variation and are likely to overestimate sensitivity, we will use the lower end of current estimates from systematic reviews, with the approximate numbers of 70% for sensitivity and 95% for specificity for illustrative purposes.