Detailed Product Description
HIV test kit
1. vitro diagnostic use
2.detecting HIV 1&2 antibodies in serum/plasma.
diagnostic test kit (Serum/Plasma test/ISO13485 certified) is an in vitro diagnostic rapid test based on lateral flow immunochromatographic assay technology. The HIV Ab test is designed by BETAI Biotechnology Co., Ltd for the purpose of qualitatively detecting Human Immunodeficiency virus antibody in human serum or plasma.
- Testing Time: 5 minutes
- Specimen: Serum or plasma
- Sampling Quantity: 50 UL, or 2 drops by the provided disposable dropper
- Storage Temperature: 2-30 C
- Shelf Life: 2 years.
- Packing Size: 40 tests/kit
- NEGATIVE: Only one band appears in the control region (C)
- POSITIVE: Two bands appear individually in the control region (C) and test region (T).
- INVALID: Control band fails to appear.
Relative Sensitivity: 99.8% (98.9%-100.0%)
Relative Specificity: 99.1% (98.3%-99.6%)
Accuracy: 99.3% (98.8%-99.7%)
* 95% Confidence Intervals
- How to distinguish a good HIV test?
1. Technical data: Accuracy>95% for HIV test. For other use (other test), the requirement and accepted criterion is usually different.
2. Pouch sealing: tight enough. If the foil pouch is not sealed well, the humidity in circustance will destroy the reactivity of antibodies labeled on NC membrane. Shelf life will be shorten down.
3. Flow speed: The shorter the better?? NO!! The reaction of antibodies on NC membrane and antigens in specimen usually requires quite a while to work sufficiently. 5 to 10 minutes was considered as the optimal result reading period.
4. Background: Good test usually gives clean background after running. If there are red smears in the reading window, it usually caused by bad colloidal gold technology or bad NC membrane. Sometimes, the defect caused false positive result in practice
- Althrough young, BETAI Bio team has till a top R&D based group. We have an experienced technician who has spent several years in developing drug test strips, and his assistants are aggresive in lateral flow field.
- Attitude to quality - BETAI Bio has a well organized quality system and we have passed the twice in field validation by ISO13485 audit group.
- Technical Support - Our product manager has good experience in solving all aspects of issues in drug test feedback. We can help our clients to make good solution in technical base.
- Multi-choice cooperation way to choose - BETEST brand distributiion, Private label, customized brand, OEM are welcomed for discussion.
- From the above data we can see, no company could fulfil all the above aspects to down the price unrestrained. Considered the cost, the giant company should have advantages to down the price of NC membrane (etc.) with big order quantity. How can a small company decrease the price to be an unbelievable level? The only answer is the quality decreasing!
- BETAI Bio expects long term partners, instead of supplying one-time deal with fake products. Please feel free to contact us via email, telephone or other way. We are ready for your request.
- We certify that our products are safe and effective,you can finish the test only by one step.I f you find some defects ,please contacts with us,we would like to afford reasonable compensation