ACON Laboratories, Inc. has been continuously monitoring the emergence of SARS-CoV-2 variants. According to the Centers for Disease Control and Prevention (CDC) COVID Data Tracker, the Omicron variant remains the dominant variant circulating in the United States. Among the new Omicron variants, BA.2.86 and JN.1 are currently the fastest-growing variants in the United States.
Based on the study results from testing live clinical samples or virus samples of variants, the Flowflex® COVID-19 Antigen Home Test can reliably detect the Omicron B.1.1.529, BA.1, BA.2, BA.2.12.1, BA.2.3, BA.2.75.5, XBB, BA.4, BA.4.6, BA.5, BA.5.5, BQ.1, BQ.1.1, BQ.1.3, BQ.1.16, BF.5 and BF.7 variants with various nucleocapsid protein mutations, including many defining mutations for the Omicron variants. Therefore, our test has demonstrated adequate sensitivity against a wide range of Omicron subvariants.
While we have not tested Omicron BA.2.86 and JN.1 samples, based on sequence data from Nextstrain, both BA.2.86 and JN.1 variants share the same defining mutations on the nucleocapsid protein. The mutations show that 7 out of 8 defining mutations of BA.2.86 and JN.1 variants are known to be detectable by our test. Since none of the mutations in BA.2.86 and JN.1 are within the epitopes of the antibodies used on our test, the new variants do not affect antibody binding. Therefore, we conclude that there is a high likelihood that the Flowflex COVID-19 Antigen Home Test will be able to detect the Omicron BA.2.86 and JN.1 variants.
We anticipate testing virus samples, once they become available, to further verify the performance of our test in detecting the Omicron BA.2.86 and JN.1 variants.
ACON will continue to monitor the evolution of COVID-19 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.