Performance of rapid antigen tests in identifying Omicron BA.4 and BA.5 infections in South Africa.

• Evolution of SARS-CoV-2 continues to challenge the existing COVID-19 prevention measures. • Performance of the SARS-CoV-2 Antigen Rapid test from Hangzhou Alltest Biotech (nasal swab) and the Standard Q COVID-19 rapid antigen test from SD biosensor (nasopharyngeal swab) was compared to the Abbott Realtime SARS-CoV-2 assay on samples collected from 540 study participants during the BA.4 and BA.5 SARS-CoV-2 wave in South Africa. • Performance of SARS-CoV-2 rapid antigen tests was not adversely affected by the presence of additional mutations in the BA.4 and BA.5 Omicron subvariants. Concerns around accuracy and performance of rapid antigen tests continue to be raised with the emergence of new SARS-CoV-2 variants. To evaluate the performance of two widely used SARS-CoV-2 rapid antigen tests during BA.4/BA.5 SARS-CoV-2 wave in South Africa (May – June 2022). A prospective field evaluation compared the SARS-CoV-2 Antigen Rapid test from Hangzhou AllTest Biotech (nasal swab) and the Standard Q COVID-19 Rapid Antigen test from SD Biosensor (nasopharyngeal swab) to the Abbott RealTime SARS-CoV-2 assay (nasopharyngeal swab) on samples collected from 540 study participants. Overall 28.52% (154/540) were SARS-CoV-2 RT-PCR positive with median cycle number value of 12.30 (IQR 9.30–19.40). Out of the 99 successfully sequenced SARS-CoV-2 positive samples, 18 were classified as BA.4 and 56 were classified as BA.5. The overall sensitivities of the AllTest SARS-CoV-2 Ag test and Standard Q COVID-19 Ag test were 73.38% (95% CI 65.89–79.73) and 74.03% (95% CI 66.58–80.31) and their specificities were 97.41% (95% CI 95.30–98.59) and 99.22% (95% CI 97.74–99.74) respectively. Sensitivity was >90% when the cycle number value was <20. The sensitivity of both rapid tests was >90% in samples infected with Omicron sub-lineage BA.4 and BA.5. Accuracy of tested rapid antigen tests that target the nucleocapsid SARS-CoV-2 protein, were not adversely affected by BA.4 and BA.5 Omicron sub-variants. [ABSTRACT FROM AUTHOR]