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SARS-CoV-2 IgM IgG Rapid Test Kit (Colloidal Gold)

TheSARS-CoV-2 IgG/IgM Rapid Test Kit is a qualitative membrane strip basedimmunoassay for the detection of antibodies (IgG /IgM) to SARS-CoV-2 inhuman Whole Blood/Serum/Plasma. The test kit consists of:1) a burgundy coloredconjugate pad containing SARS-CoV-2 recombinant envelope antigens conjugatedwith Colloid gold (SARS-CoV-2 conjugates), 2) a nitrocellulose membrane stripcontaining two test lines (IgG / IgM lines) a nd a control line (C line). TheIgM line is pre-coated with the Mouse anti-Human IgM antibody, IgG line iscoated with Mouse anti-Human IgG antibody. 

When an adequate volume of testspecimen is dispensed into the sample well of the test cassette, the specimenmigrates by capillary action across the cassette. IgM anti-Novel coronavirus,if present in the specimen, will bind to the SARS-CoV-2 conjugates. Theimmunocomplex is then captured by the reagent pre-coated on the IgM ba nd,forming a burgundy colored IgM line, indicating a SARS-CoV-2 IgM positive testresult. IgG anti-Novel coronavirus, if present in the specimen, will bind tothe SARS-CoV-2 conjugates. The immunocomplex is then captured by the reagentpre-coated on the IgG line, forming a burgundy colored IgG line, indicating aSARS-CoV-2 IgG positive test result. Absence of any T lines (IgG /IgM) suggestsa negative result. To serve as a procedural control, a colored line will alwaysappear at the control line region indicating that proper volume of specimen has been added a nd membrane wicking has occurred.

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Address:Triplex Biological Park,No.2041 Xizhou Road,Xike Town,Tongan District,Xiamen,Fujian,China

Internet Drug Information:(Fujian)-Non-operating-2017-0020

license number:Fujian Food and Drug Administration Production No. 20110184

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license number:Yuxia Food and Drug Administration Operation No. 20150093