RESUMO
ImportanceA steady increase in acute respiratory syndrome coronavirus 2 (SARS-CoV-2) cases worldwide is causing some regions of the world to withstand a third or even fourth wave of contagion. Swift detection of SARS-CoV-2 infection is paramount for the containment of cases, prevention of sustained contagion; and most importantly, for the reduction of mortality. ObjectiveTo evaluate the performance and validity of the COVISTIX rapid antigen test, for the detection of SARS-CoV-2 in an unselected population and compare it to Panbio rapid antigen test and RT-PCR. DesignThis is comparative effectiveness study; samples were collected at two point-of-care facilities in Mexico City between May and August 2021. ParticipantsRecruited individuals were probable COVID-19 cases, either symptomatic or asymptomatic persons that were at risk of infection due to close contact to SARS-CoV-2 positive cases. Diagnostic interventionRT-PCR was used as gold standard for detection of SARS-CoV-2 in nasal and nasopharyngeal swabs, study subjects were tested in parallel either with the COVISTIX or with Panbio rapid antigen test. Main outcomeDiagnostic performance of the COVISTIX assay is adequate in all commers since its accuracy parameters were not affected in samples collected after 7 days of symptom onset, and it detected almost 65% of samples with a Ct-value between 30 and 34. ResultsFor the population tested with COVISTIX (n=783), specificity and sensitivity of the was 96.0% (CI95% 94.0-98.0) and 81% (CI95% 76.0-85.0), as for the Panbio (n=2202) population, was 99.0% (CI95%: 0.99-1.00) and 62% (CI%: 58.0-64.0%), respectively. Conclusions and relevanceThe COVISTIX rapid antigen test shows a high performance in all comers, thus, this test is also adequate for testing patients who have passed the peak of viral shedding or for asymptomatic patients.
