The Immuno Biotech Antigen Rapid Test is an assay that can be used for the diagnosis of SARSCoV-2 infection. This assays tests for the presence of SARS-CoV-2 N-protein is swab specimen. In this study, the Immuno Biotech antigen rapid test was evaluated with the Roche SARS-CoV-2 Rapid Antigen Test Nasal and the PCR. PerkinElmer reverse transcriptase real time quantitative polymerase chain reaction (rt-RT-qPCR) was used for discrepancy analysis. In total, 80 negative and 40 positive COVID-19 samples were included in this comparison. However, variant 27390 was detected as weak positive. The lowest detectable concentration was around 140.000 dPCR copies/mL. The Roche antigen rapid test had exactly the same results and detected the same samples as false negative. Furthermore, the Roche antigen rapid test also showed a limit of detection around 140.000 dPCR copies/mL. The performance of the antigen rapid tests are similar in this evaluation.
You may be concerned about whether our products can detect mutated COVID-19 strains?
Besides the COVID Delta Strain, Recently, the Sars-CoV-2 new variant Omicron (B.1.1.529) strains were spreading from South Africa and across the world and makes it more difficult to prevent and control. The mutation sites on the nucleocapsid protein (N protein) are located at DEL31/33, P13L, R203K, and G204R, where are all out of the epitope region (N47-A173, NTD region) recognized by our antibody pairs. Thus, the Sars-CoV-2 Antigen Rapid Test (COVID-19 Ag) is theoretically competent for the detection of the Sars-CoV-2 new variant Omicron strains.