Study population and setting
Seven antigen point of care tests (AgPOCT) were compared against an established RT-PCR assay. The sensitivity of each test was determined by using recombinant SARS-CoV-2 nucleoprotein, SARS-CoV-2 cell culture supernatants, positive patient samples, and healthy donors as controls. Patient samples were collected at Charité Medical Center in Berlin, Germany between March and October 2020; healthy donor samples were collected from employees of the Institute of Virology (age range: 22-61 years).
Summary of Main Findings
138 SARS-CoV-2 RT-PCR positive samples were tested against the seven AgPOCT. Cumulative specificities of the seven POCT were: Abbott Panbio™ COVID-19 Ag Rapid Test (99.26%), RapiGEN BIOCREDIT COVID-19 Ag (100%); Healgen® Coronavirus Ag Rapid Test Cassette (88.24%); Coris Bioconcept Covid.19 Ag Respi-Strip (100%); R-Biopharm RIDA®QUICK SARS-CoV-2 Antigen (94.85%); NAL von minden NADAL COVID19-Ag Test (99.26%); Roche/SD Biosensor SARS-CoV Rapid Antigen Test (98.53%).
Interpretation of results that were displayed as a band on paper was recorded by two individuals. The usages of recombinant nucleocapsid protein and cell culture supernatants were used to validate accuracy before use with patient and control/healthy samples.
The analytical sensitivity of these tests, using the quantified cultured virus, was not compared to the standard of care molecular diagnostics. It would have also been very helpful to correlate the seven AgPOCT results to the time of the specimen collection after the onset of the symptoms. All assays had some cross-reactivity with SARS-CoV and could potentially result in a false positive. No other information was provided from the RT-PCR positive SARS-CoV-2 samples (i.e. severity of disease) and thus sensitivities might differ between asymptomatic, mild, and severe cases of COVID-19.
Comparison of seven different AgPOCT and their sensitivities provide alternative screening to monitor/identify infectivity instead of infection screening.
This review was posted on: 14 January 2021