Uncut sheet for HIV Rapid test
1. INTEDED USE
The HIV Antibody Rapid Test Device (the “Uncut Sheet ” format for manufacturing use) is intended for the qualitative detection of antibodies to Human Immunodeficiency Virus types 1 and 2 (HIV-1 and HIV-2) in human serum, plasma, venous whole blood.
This test is intended for in vitro diagnostic professional use and serves as an aid in the screening and diagnosis of HIV-1/HIV-2 infection in patients with clinical signs and symptoms suggestive of HIV infection, or for screening individuals at risk of HIV exposure.
The test utilizes recombinant HIV antigens (including predominant epitopes of gp41, gp120 of HIV-1 and gp36 of HIV-2) immobilized on the membrane and conjugated to colloidal gold particles to capture HIV-1/2 antibodies present in the specimen. The device provides presumptive (preliminary) screening test results.
This product is intended for use by trained healthcare professionals or laboratory personnel. This product is for manufacturing use only and is intended for further processing into final device format.
2. PRODUCT SPECIFICATION
| Model No. | HIV Ab Uncut sheet |
| Methodology | Colloidal Gold |
| Sample Type | Whole blood /Serum/Plasma |
| Time to Result | 15~20mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485, CE Certificate, UCKA MHRA Certificate |
|
Feature • High sensitive • result reading in 15-20 minutes • Easy operation • High Accuracy |
PACKING * 20 bags /CTN * Aluminum foil bag labeling * shrink wrap
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3.TEST METHOD
| 1 | Remove test device from aluminum foil pouch, lie it on a horizontal workbench, and do a good job in marking. |
| 2 | For serum and plasma samples, take 2 drops and add them to the spiked well; however, if the sample is a whole blood sample, take 2 drops and add them to the spiked well and need to add 1 drop of sample diluent. |
| 3 | Interpret result within 10-15 minutes, and detection result is invalid after 15 minutes (see detailed results in result interpretation). |
4.RESULT EVALUATION AND EXPLANATION
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
6.EXHIBITION
