Summary Rapid COVID-19 diagnosis in the hospital is essential, although this is complicated by 30%–50% of nose/throat swabs being negative by SARS-CoV-2 nucleic acid amplification testing (NAAT). Furthermore, the D614G spike mutant dominates the pandemic and it is unclear how serological tests designed to detect anti-spike antibodies perform against this variant. We assess the diagnostic accuracy of combined rapid antibody point of care (POC) and nucleic acid assays for suspected COVID-19 disease due to either wild-type or the D614G spike mutant SARS-CoV-2. The overall detection rate for COVID-19 is 79.2% (95% CI 57.8–92.9) by rapid NAAT alone. The combined point of care antibody test and rapid NAAT is not affected by D614G and results in very high sensitivity for COVID-19 diagnosis with very high specificity. Graphical Abstract Highlights Combined rapid antibody + nucleic acid detection correctly diagnoses SARS-CoV-2 Rapid antibody tests detect immune responses against SARS-CoV-2 bearing D614G Rapid SARS-CoV-2 antibody tests do not cross-react with antibodies to seasonal CoV False positivity in SARS-CoV-2 finger prick blood antibody tests can be very low Mlcochova et al. report that combined rapid nucleic acid amplification testing (NAAT) and finger prick blood antibody tests can substantially improve the diagnosis of COVID-19 as compared to NAAT alone and is able to detect the SARS-CoV-2 Spike D614G variant that dominates the pandemic.
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