K-Influenza A/B Antigen Test
Purpose of use
The K-Influenza A/B Antigen Test is intended for the detection of Influenza A and Influenza B nucleocapsid protein antigen in nasopharyngeal swab specimens directly collected from suspected flu infection within 7 days after symptom onset. This test kit aims for in vitro diagnostic only and is intended for professional use.
Test principle
The K-Influenza A/B Antigen Test is a colored chromatographic immunoassay. After extraction, the sample is dropped on sample pad, and the buffer flows through the conjugate pad containing anti-nucleocapsid conjugated gold nanoparticle. If the sample contains Influenza A/B viral nucleocapsid antigen, the antigen binds to the conjugate to form an anti-nucleocapsid gold conjugate nucleocapsid complex. The complex flows to the test line coated with anti-nucleocapsid antibody, leading to the formation of an anti-nucleocapsid gold conjugate nucleocapsid anti-nucleocapsid complex, which will produce a visible color on the test line.
Positive results indicate the presence of Influenza A or Influenza B antigens in the tested specimen. To ensure the accuracy of the result, real time RT-PCR assay should be performed further as a confirmatory test.
Negative results indicate no Influenza A or Influenza B antigens in the tested specimen, but the possibility of influenza infection is not excluded. Duration of infection, patient history, signs and symptoms need to be considered for diagnosis.
Provided materials
The K-Influenza A/B Antigen Test for one box contains the following items
1. Individually foil-pouched test cassettes, with a desiccant (25 packs)
2. Sample extraction buffer in a sample extraction tube (25 tubes)
3. Sterile nasopharyngeal swab (25 pieces)
4. Paper rack (1 piece)
5. Instruction for Use
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