HBV rapid test kits

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HBV-5 PANEL TEST For the qualitative assessment of the markers of hepatitis B virus infection in human serum, plasma and whole blood. INTENDED USE: This HBV Panel Test is an immunochromatographic assay to quickly detect five major markers of HBV infections, HBsAg, Anti-HBs (HBsAb), Anti-HBc (HBcAb), HBeAg and Anti-HBe (HBeAb) in human blood specimens. It is intended for use in medical institution as an aid for diagnosis and management of patients related to infection with hepatitis B as well for screening of blood donors or blood products. SPECIFICATION: 1) Specimen: whole blood/serum/plasma 2) Format: strip/cassette/panel 3) Accuracy: HBsAg-99.6% HBsAb-97.9% HBcAb-97.4% HBeAg-99.6% HBeAb-98.2% FEATURE: 1) Simple: simply add specimen and dilution(if necessary) into sample well 2) Rapid: results come out early than 30 minutes 3) Visually interpreted: don’t need any equipment 4) Stable: more than 12 month period of validity PACKING 1) Strip: 100 tests/box, 500 tests/box 2) Cassette: 25 tests/box, 50 tests/box 3) Panel: 25 tests/box, 50 tests/box ASSAY PROCEDURE: 1) Allow the strip and sample to reach room temperature if necessary. 2) Use provided plastic pipet to add 2 to 3 drops (80-120 uL) of serum or plasma to each corresponding sample well respectively. 3) Results at 30 minutes. For HBsAg, HBsAb and HBeAg, the strong positive sample may show results earlier than 30 minutes. For HBeAb and HBcAb, negative results may show results earlier than 30 minutes. PRINCIPLE: HBsAg test is an antibody sandwich immunoassay. Colloidal gold conjugated monoclonal antibodies reactive to HBsAg (sAb-Au) are dry-immobilized onto a nitrocellulose membrane strip. When the sample is added, it migrates by capillary diffusion trough the strip rehydrating the gold conjugate. If present, HBsAg will bind with the gold conjugated antibodies forming particles. These particles will continue to migrate along the strip until the Test Zone (T) where they are captured by anti-HBs antibodies immobilized there and a visible red line appears. If there is no HBsAg in sample, no red line will appear in the Test Zone (T). The gold conjugate will continue to migrate alone until is captured in the Control Zone (C) from immobilized goat, anti-mouse IgG antibody and aggregating in a red line, which indicates the validity of the test.

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Boson Biotechnology Co,.Ltd.

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