HIV, HBsAg, HCV & Syphilis Combo Rapid Test
Pack size
10 tests
Product Description
The Biopanda HIV, HBsAg, HCV, & Syphilis Combo Rapid Test is a chromatographic immunoassay for the qualitative detection of antibodies to HIV type 1 and type 2, Hepatitis B surface antigen (HBsAg), antibodies to Hepatitis C Virus, and Syphilis antibodies (IgG and IgM) to Treponema Pallidum (TP) in whole blood, serum or plasma.
Test Attributes
- Whole blood, serum, or plasma may be used for testing
- Results available in only 10 minutes
- Easy to use
- Results can be read visually
- No need for an analyser
- Cost effective method for assisting to diagnose HIV, Hep B, Hep C, and Syphilis infections
Test Procedure
- Allow test cassette, specimen, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
- Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
- Place the test cassette on a clean and level surface. Hold the dropper vertically and transfer 2 drops of specimen (approximately 50 μl) to the specimen area each, then add 1 drop of buffer (approximately 40 μl), respectively. Start the timer. See the illustration below.
- Wait for the coloured line(s) to appear. The test result should be read at 10 minutes. Results read after 20 minutes are considered invalid
Principle
The Biopanda HIV, HBsAg, HCV, & Syphilis Combo Rapid Test is a qualitative, membrane based immunoassay for the detection of antibodies and antigens in whole blood, serum or plasma. Each membrane is pre-coated with the relevant antigen or antibody in the test line regions. During testing, the whole blood, serum or plasma specimen reacts with recombinant antigen or specific antibodies. The mixture then migrates laterally on each of the membranes chromatographically by capillary action and reacts with recombinant antigen or antibody complexes on the membrane in the test line region. If the specimen contains the relevant antigen or antibody being tested for, one coloured line will appear in the test line region. This indicates a positive result for each test. If the specimen does not contain the relevant antigen or antibody being tested for, no coloured line will appear in the test line region indicating a negative result. To serve as a procedural control, a coloured line will always appear in the control line regions indicating that proper volume of specimen has been added and membrane wicking has occurred.
Performance Characteristics
| Test | Sensitivity | Specificity | Accuracy |
|---|---|---|---|
| HIV 1.2 | >99.9% | 99.8% | 99.9% |
| HBsAg | >99.9% | 99.7% | 99.8% |
| HCV | >99.9% | 99.7% | 99.8% |
| Syphilis | 95.9% | 99.3% | 98.1% |
Storage Conditions
Store the kit between 2-30°C and ensure the kits are not frozen or stored in direct sunlight. The test is valid until the expiration date printed on the foil wrapping.
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