| Classification: | Biological Diagnostics |
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| Type: | Urine Analyzer |
| Certification: | CE, FDA, ISO13485 |
| Group: | All of The People |
| Medical Device Regulatory Type: | Type 1 |
| Medical Devices Reg./Record No.: | Sdaa-20123609562 |
| Samples: |
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| Customization: |
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Suppliers with verified business licenses
Audited Supplier Ce Marked Ivd Infections Disease Diagnostic HIV Rapid Test Cassette HIV 1/2 Ab Home Rapid Test Cassette
Product Description
The HIV 1/2 Rapid Test kits (Whole Blood/Serum/Plasma) detects antibodies to HIV-1 and HIV-2 through visual interpretation of color development on the internal strip.Recombinant HIV-1 and HIV-2 antigens are immobilized on the '2' test region of the membrane.During testing,the specimen reacts with HIV antigen conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane.If there are sufficient HIV-1 or HIV-2 antibodies in the specimen, a colored band will for m at the corresponding test region of the membrane.The presence of this colored band indicates a positive result, while its absence indicates a negative result.The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
Detailed Packing
| HIV 1/2 Human Immunodeficiency Virus 1/2 Test | HIV-W11 | Serum/Plasma/Whole Blood | Strip | 99.70% | 50 pcs |
| HIV 1/2 Human Immunodeficiency Virus 1/2 Test | HIV-W23H | Serum/Plasma/Whole Blood | Cassette for Selftesting | 99.70% | 1 pc |
| HIV 1/2 Human Immunodeficiency Virus 1/2 Test | HIV-W23 | Serum/Plasma/Whole Blood | Cassette | 99.70% | 20 pcs |
| HIV 1/2 Human Immunodeficiency Virus 1/2 Test (Tri-lines) |
HIV-3-W11 | Serum/Plasma/Whole Blood | Strip | 99.70% | 50 pcs |
| HIV 1/2 Human Immunodeficiency Virus 1/2 Test (Tri-lines) |
HIV-3-W23 | Serum/Plasma/Whole Blood | Cassette | 99.70% | 20 pcs |
1) Let the pouched test come to room temperature(15-30°C). Remove the test device from the foil pouch, and place it on a flat, dry surface.
2) Transfer the specimen by Disposable pipette:
Draw and transfer 1 drop (approximately 30μl) of whole blood (or 20μl serum or plasma)to the sample well of the test device, then add 2 drops of Assay diluent (approximately 60μl) and start the timer.
3) As the test begins to work, you will see purple color move across the result window in the center of the test device.
4) Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.
Caution: The above interpreting time is based on reading the test results at room temperature range of 15 to 30 °C. If your room temperature is significantly lower than 15 °C, then the interpreting time should be properly increased to 30 minutes.
FAQ
Q1: What's the method u use to do the test?
A: Colloidal Gold Method.
Q2: What's ur MOQ ?
A: Always, for strip format, the MOQ is 5000pcs. While for cassette format, MOQ is 2000pcs, same as midstream.
Q3: What's ur packing of the tests?
A: If u choose the low cost, we will suggest you the bulk packing to go. Which means 1 test in a single pouch, then 100/40 pouches in a plastic bag, 50 bags in a carton. If u need to sell in pharmacy/chain shop or some countries which have strict requirements about the packing, u can choose to pack in a box, like 100pcs in a box, or even 1 test in a single box.
Q4: What's the main differences when comparing products from different suppliers?
A: U can compare the mainly features of the test: Accuracy, Sensitivity, Specificity, and then the Price.
Q5: Some tests can be tested with serum/plasma or with whole blood, so what's the difference?
A: Well, if the specimen is whole blood, people will need buffer, lancet and alcohol swab to help the test. If they buy all the accessories, they can test very easily at home. But if the specimen is serum/plasma, it will need centrifuge to separate serum from whole blood first. This way, it's better to use at lab or hospital. And in some words, serum/plasma test will always give a more accurate results.
Q6: How can i distinguish a good test kit?
A: U can judge from the 4facts:Technical data: Such as the accuracy, specificity and sensitivity.
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.
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. You can refer to the instruction for more accurate time.
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
Suppliers with verified business licenses
Audited Supplier 
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