Uncut sheet for HIV Rapid test
1. INTEDED USE
This kit is suitable for the in vitro qualitative detection of human immunodeficiency virus HIV (1/2) antibodies in human serum/plasma/whole blood samples as an aid in the diagnosis of human immunodeficiency virus HIV (1/2) antibody infection. This kit provides HIV antibody test results only and the results obtained should be analyzed in conjunction with other clinical information. It is intended for use by medical professionals only.
2. PRODUCT SPECIFICATION
| Model No. | HIV 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
