The case was sent to the manufacturer for investigation.In general, the rapid ag test result should not be the sole basis for the diagnosis; depending on the situation confirmatory testing is required (pcr).The relative diagnostic sensitivity compared to rt-pcr, written in the instructions for use of pilot®covid-19 at-home test is 93.2%.Probable causes of false negative result: inappropriate sampling: it might be a false negative when sampling is not performed as described in the ifu.The insufficient amount of viruses in samples: the limit of detection varies with the type of test.A molecular test, such as a pcr test has a higher sensitivity than a rapid antigen test.As a result, it could be a false negative with rapid tests at the beginning of symptoms or with a small amount of covid-19 virus, lower than the detection limit of the product.The investigation did not identify a product problem.
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