Uncut sheet for HIV Ab/P24 Rapid test
1. INTEDED USE
This kit is suitable for the in vitro qualitative detection of human immunodeficiency virus antibody HIV (1/2) and antigen (p24) in human serum/plasma/whole blood samples as an aid in the diagnosis of human immunodeficiency virus infection. This kit provides results for the detection of human immunodeficiency virus antibodies HIV (1/2) and antigen (p24) only and the obtained result shall be analyzed in combination with other clinical information. It must only be used by healthcare professionals.
2. PRODUCT SPECIFICATION
| Model No. | HIV Ab/P24 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 |
|
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
