Covid-19 antigen testing: better than we know? A test accuracy study

Covid-19 抗原检测:比我们已知的更好?一项检测准确性研究

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作者:Miroslav Homza, Hana Zelena, Jaroslav Janosek, Hana Tomaskova, Eduard Jezo, Alena Kloudova, Jakub Mrazek, Zdenek Svagera, Roman Prymula

Background

Antigen testing for SARS-CoV-2 is considered to be less sensitive than the standard reference method - real-time PCR (RT-PCR). It has been suggested that many patients with positive RT-PCR 'missed' by antigen testing might be non-infectious.

Conclusions

We propose that viability testing should be always performed when evaluating a new antigen test. A well-chosen and validated antigen test provides excellent results in identifying patients who are shedding viable virus (although some caveats still remain) in the real-world high-throughput setting of asymptomatic or mildly symptomatic individuals.

Methods

In a real-world high-throughput setting for asymptomatic or mildly symptomatic patients, 494 patients were tested using RT-PCR as well as a single lateral flow antigen test (Ecotest, AssureTech, China). Where the

Results

The overall sensitivity of the used antigen test related to the RT-PCR only was 76.2%, specificity was 97.3%. However, 36 out of 39 patients 'missed' by the antigen test contained no viable virus. After adjusting on that, the sensitivity grew to 97.7% and, more importantly for disease control purposes, the negative predictive value reached 99.2%. Conclusions: We propose that viability testing should be always performed when evaluating a new antigen test. A well-chosen and validated antigen test provides excellent results in identifying patients who are shedding viable virus (although some caveats still remain) in the real-world high-throughput setting of asymptomatic or mildly symptomatic individuals.

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