Biomex has carried out a study to establish the performance of the AESKU.RAPID SARS-CoV-2 Antigen Test in detecting the SARS-CoV-2 Omicron sublineages BA.4 & BA.5.
This study evaluated the diagnostic sensitivity of the AESKU.RAPID SARS-CoV-2 concerning the BA.4 and BA.5 sublines of the SARS-CoV-2 Omicron (B.1.1.529) variant. For this purpose, samples collected as anterior nasal swabs were analyzed. All samples were tested simultaneously for the AESKU.RAPID SARS-CoV-2 and real-time RT-PCR assays.
The overall diagnostic sensitivity of the AESKU.RAPID SARS-CoV-2 for BA.4 and BA.5 variants was 94.6%.
In summary, the results of this study show a very high diagnostic sensitivity for the AESKU.RAPID SARS-CoV-2 concerning the SARS-CoV-2 Omicron (BA.4 & BA.5) variants, meeting the requirements of >80% (rapid tests) compared to the SARS-CoV-2 real-time RT-PCR test. AESKU.RAPID can detect all samples collected within seven days of symptom onset.
The AESKU.RAPID SARS-CoV-2 can be expected to qualitatively detect the antigen of the SARS-CoV-2 Omicron (BA.4 & BA.5) variant in human swab specimens with a high degree of confidence.