SARS-CoV-2 Antigen Rapid Test

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ACON Statement Letter of SARS-CoV-2 variant Omicron
Date:2021-11-28 Click:

To Whom It May Concern:

Thank you for your interest in the FlowflexSARS-CoV-2 Antigen Rapid Test. We, ACON Biotech (Hangzhou) Co., Ltd. as themanufacturer of Flowflex SARS-CoV-2 Antigen Rapid Test, hereby declare thatACON are monitoring the emergence of a new strain of SARS-CoV-2 which hasbecome prevalent in the 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) have several mutations in the spike protein and a fewmutations in the nucleocapsid protein. There is no obvious difference observedwhen testing with different nucleocapsid protein recombination antigens (Alpha,Beta, Gamma, Delta, Epsilon, Zeta, Eta, Theta, lota, Kappa, Lambda, Mu andDelta plus) basing on these different variants of SARS-CoV-2. For Omicron, bytheoretical analysis of the mutations in the nucleocapsid protein, it shouldnot interfere the detection of Flowflex SARS-CoV-2 Antigen Rapid Test. So we donot anticipate that these variants will have any effect on test performance.


ACON Biotech (Hangzhou) Co., Ltd.

Nov 28, 2021