Combined Point-of-Care Nucleic Acid and Antibody Testing for SARS-CoV-2 following Emergence of D614G Spike Variant.
Mlcochova P., Collier D., Ritchie A., Assennato SM., Hosmillo M., Goel N., Meng B., Chatterjee K., Mendoza V., Temperton N., Kiss L., James LC., Ciazynska KA., Xiong X., Briggs JAG., Nathan JA., Mescia F., Bergamaschi L., Zhang H., Barmpounakis P., Demeris N., Skells R., Lyons PA., Bradley J., Baker S., Allain JP., Smith KGC., Bousfield R., Wilson M., Sparkes D., Amoroso G., Gkrania-Klotsas E., Hardwick S., Boyle A., Goodfellow I., Gupta RK., Cambridge Institute of Therapeutic Immunology and Infectious Disease-National Institute of Health Research (CITIID-NIHR) COVID BioResource Collaboration None.
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.