False-negative rate of SARS-CoV-2 RT-PCR tests and its relationship to test timing and illness severity: A case series.

OBJECTIVE

To determine the false-negative rate of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse-transcription polymerase chain reaction (RT-PCR) test results, and to describe the characteristics of coronavirus disease 2019 (COVID-19) patients with false-negative results.

METHODS

We validated SARS-CoV-2-positive RT-PCR test results performed in hospitalized patients between February 1 and August 31, 2020 and classified the patients according to disease severity.

RESULTS

In total, 2038 SARS-CoV-2 RT-PCR tests were performed on 1890 patients. Of these, 145 patients had positive results and were diagnosed with COVID-19. Among the 145 patients with COVID-19, the initial RT-PCR tests were negative in five patients. Of these, three had moderate illness and were initially tested in the early stage of disease, and two had severe illness and were initially tested in the late stage of disease, when RT-PCR testing has lower sensitivity due to viral clearance.

CONCLUSIONS

These findings suggest that false-negative results can be caused by both observer errors and by low viral RNA levels in the later stages of disease, after the infection has cleared. Clinicians should be aware that patients with COVID-19 can have negative RT-PCR test results in the later stages of infection.