Intended Use
The Influenza A +B Test is a rapid chromatographic immunoassay for the qualitative detection of influenza type A and B nucleoprotein antigens in nasopharyngeal swab and nasal aspirate specimens. This kit is intended to be used as an aid in the diagnosis of influenza A and influenza B virus in nasal swab specimens.
Principle
The Influenza A +B Test is a qualitative membrane strip based immunoassay for the detection of influenza type A and B nucleoprotein antigens in nasopharyngeal swab and nasal aspirate specimens. In this test procedure, influenza type A antibody is immobilized in the A line, influenza type B antibody is immobilized in the B line. After a specimen is placed in the specimen well, it reacts with influenza type A antibody and/or B antibody coated particles that have been applied to the specimen pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized antibody. If the specimen contains influenza type A, a colored line will appear in the A line region indicating a influenza type A positive result. If the specimen contains influenza type B, a colored line will appear in the B line region indicating a influenza type B positive result. Absence of any T lines (A and B) suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.
Storage and Stability
1.Store as packaged in the sealed pouch at room temperature or refrigerated (4-30â?? or 40-86â??). The test device is stable through the expiration date printed on the sealed pouch.
2.The test must remain in the sealed pouch until use.
General information One-step influenza a/b test is detection influenza type a and type b nucleoprotein antigen extracted from the nasal swab specimen. Sensitivity : 91.3% , specificity : 95.7% Detection limit:5.1x105tcid50/ml Specimen: nasal swab Reading time : 15-20min
Rapid Influenza A + B Test Card Intended Use Influenza A+B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza type A and type B nucleoprotein antigens in nasopharyngeal swab, nasal swab and nasal aspirate samples. The identification is based on the monoclonal antibodies specific for the nucleoprotein of Influenza virus A. It is intended to aid in the rapid diagnosis of influenza infection. Negative results should be confirmed by other methods, such as cell culture. Contents of Kit Flu A + B Test Card 20 ea Sample Extraction Buffer 1 ea Extraction Tube 20 ea Nozzle With Filter 21 ea Sterilized Swab 20 ea Tube Stand 1 ea Instructions For Use 1 ea Storage And Stability Store the Influenza A+B Rapid Test at room temperature or refrigerated (2-30ípC). Do not freeze. All reagents are stable until the expiration dates marked on their outer packaging and buffer vial. Pre Cautions 1. For in vitro diagnostic use only. 2. Do not use after the expiration date. 3. The test device should remain in the sealed pouch until use. 4. If the Influenza A+B Rapid Test kit was kept refrigerated, let all the reagents warm up to room temperature (15ípC -30ípC) before proceeding with the test. 5. Wear gloves when handing the samples, avoid touching the reagent membrane with your fingers. 6. Discard gloves, swabs, test tubes, and test devices in accordance with the local regulation. 7. Visibly bloody samples should not be used for the testing. 25 tests/kit, 40 kits/carton
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