ACON Laboratories, Inc. has been continuously monitoring the emergence of SARS-CoV-2 variants to ensure that the Flowflex® COVID-19 Antigen Home Test can detect them. The Omicron variant of concern remains the dominant variant circulating globally, accounting for nearly all sequences submitted to GISAID. Among the new Omicron variants, BQ.1.1, BQ.1, XBB.1.5, XBB, and BF.7 represent the highest proportion of circulating variants in the United States.
An independent evaluation conducted by the National Institutes of Health’s (NIH) RADx program has indicated that the Flowflex COVID-19 Antigen Home Test detects the variants BQ.1.1 and BA.2 in live clinical samples. Another evaluation conducted by a third-party laboratory has shown that the Flowflex COVID-19 Antigen Home Test detects live variants BA.4 and BA.5.
According to the GISAID in-silico analysis and the pairwise sequence alignment comparison of Nucleocapsid protein from the tested variants (BQ.1.1, BA.2, BA.4, and BA.5), we can conclude that there is a high likelihood that variants BQ.1, XBB.1.5, XBB, and BF.7 are detectable by the Flowflex COVID-19 Antigen Home Test. We anticipate testing virus samples, once they become available, to further verify the performance of our test in detecting the Omicron variant.
ACON will continue to monitor the evolution of SARS-CoV-2 variants in circulation worldwide and evaluate the performance of our assays against future variants to maintain the high level of product performance our customers have come to rely upon.
If you have questions, please contact customer support at 1 (800) 838 9502.