HBsAg /HCV /HIV Combo Rapid Test Cassette
HBsAg /HCV /HIV Combo Rapid Test Cassette
INTENDED USE
The HBsAg/HCV/HIV Combo Rapid Test Cassette (Serum /Plasma) is a rapid chromatographic immunoassay for the qualitative detection of Hepatitis B surface antigen(HBsAg),antibodies to Hepatitis C Virus and antibodies to HIV type 1, type 2 in serum or plasma..
STORAGE & STABILITY
The test kits must be stored at 2-30℃in the sealed pouch and under dry conditions.
WARNINGS AND PRECAUTIONS
1) All positive results must be confirmed by an alternative method.
2) Treat all specimens as though potentially infectious. Wear gloves and protective clothing when handling specimens.
3) Devices used for testing should be autoclaved before disposal.
4) Do not use kit materials beyond their expiration dates.
5) Do not interchange reagents from different lots.
SAMPLE COLLECTION AND STORAGE
Allow the test, specimen, buffer and/or controls to room temperature (15-30°C) prior to testing.
2. Place the test cassette on a clean and level surface. Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 50 ul) to the each sample well, then add 1drop of buffer (approximately 40 ul) to each sample well and start the timer. See the illustration below.
3. Wait for the colored line(s) to appear. The test result should be read at 10 minutes.
Do not interpret the result after 20 minutes.
LIMITATION
1) Only clear, fresh, free flowing Serum / Plasma can be used in this test.
2) Fresh samples are best but frozen samples can be used. If a sample has been frozen, it should be allowed to thaw in a vertical position and checked for fluidity. Whole Blood can not be frozen.
3) Do not agitate the sample. Insert a pipette just below the surface of the sample to collect the Specimen.
READING THE TEST RESULTS
1) Positive: Both a purplish red test band and a purplish red control band appear on the membrane. The lower the antibody concentration, the weaker the test band.
2) Negative: Only the purplish red control band appears on the membrane. The absence of a test band indicates a negative result.
3) Invalid result: There should always be a purplish red control band in the control region, regardless of the test result. If a control band is not seen, the test is considered invalid. Repeat the test using a new test device.
Note: It is normal to have a slightly lightened control band with very strong positive samples, as long as it is distinctly visible.
