Diagnosing SARS-CoV-2 infection: the danger of over-reliance on positive test results

Abstract

AbstractContrary to the practice during previous epidemics, with COVID-19 health authorities have treated a single positive result from a PCR-based test as confirmation of infection, irrespective of signs, symptoms and exposure. This is based on a widespread belief that positive results in these tests are highly reliable. However, evidence from external quality assessments and real-world data indicate enough a high enough false positive rate to make positive results highly unreliable over a broad range of scenarios. This has clinical and case management implications, and affects an array of epidemiological statistics, including the asymptomatic ratio, prevalence, and hospitalization and death rates, as well as epidemiologic models. Steps should be taken to raise awareness of false positives and reduce their frequency. The most important immediate action is to check positive results with additional tests, at least when prevalence is low.Key messagesThe high specificities (usually 100%) reported in PCR-based tests for SARS-CoV-2 infection do not represent the real-world use of these tests, where contamination and human error produce significant rates of false positives.Widespread lack of awareness of the real-world false positive rates affects an array of clinical, case management and health policy decisions. Similarly, health authorities’ guidance on interpreting test results is often wrong.Steps should be taken immediately to reduce the frequency and impacts of false positive results, including checking positive results with additional tests at least when prevalence is low.