To whom it may concern,




Thank you for your interest in the Flowflex SARS-CoV-2 Antigen Rapid Test.

We, ACON Biotech (Hangzhou) Co., Ltd. as the manufacturer of Flowflex SARS-CoV-2 Antigen Rapid Test, hereby declare that ACON are monitoring the emergence of a new strain of SARS-CoV-2 which has become prevalent in UK, South Africa, Brazil/Japan, India, USA, Philippines, Peru, Colombia and other communities. SARS-CoV-2 of Alpha (B1.1.7), Beta (B.1.351), Gamma (P.1), Delta (B.1.617.2), Epsilon (B.1.427/B.1.429), Zeta (P.2), Eta (B.1.525), Theta (P.3), Iota (B.1.526), Kappa (B.1.617.1), Lambda (C.37), Mu(B.1.621), Delta plus (AY.4.2), Omicron(B.1.1.529, BA.1, BA.1.1, BA.2, BA.3) have several mutations in the spike protein and a few mutations in the nucleocapsid protein.

There is no obvious difference observed when testing with different nucleocapsid protein recombination antigens (Alpha, Beta, Gamma, Delta, Epsilon, Zeta, Eta, Theta, lota, Kappa, Lambda, Mu, Delta plus and Omicron) basing on these different variants of SARS-CoV-2, so we do not anticipate that these variants will have any effect on test performance.



Sincerely,
ACON Biotech (Hangzhou) Co., Ltd.
January 29, 2022