Uncut sheet for Hepatitis C Virus Antibody HCV One Step Rapid Test
1. INTEDED USE
Diagnostic Kit for Hepatitis C Virus Antibody (Colloidal Gold )is for the qualitative detection of HCV antibody in human serum or plasma,which is important auxiliary diagnostic value for infection with hepatitis C.All positive sample must be confirmed by other methodologies. This test is intended for healthcare professional use only
2. PRODUCT SPECIFICATION
| Model No. | HCV Uncut sheet |
| Methodology | Colloidal Gold |
| Sample Type | Serum,Plasma,Whole blood |
| Time to Result | 15 mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485, CE Certificate, UCKA MHRA Certificate |
|
Feature • High sensitive • result reading in 5 minutes • Easy operation • High Accuracy |
PACKING * 20 bags /CTN * Aluminum foil bag labeling * shrink wrap
|
3.TEST METHOD
| 1 | Take out the test device from sealed foil pouch and place on a dry, clean and level surface. |
| 2 | Be sure to label the device with specimen’s ID number. |
| 3 | Fill the pipette dropper with the specimen. Hold the dropper vertically and transfer 1 drop of whole blood/serum/plasma specimen (approximately 10 μL) into the specimen well (S) , and make sure that there are no air bubbles. Then add 3 drops of sample diluent (approximately 80-100 μL) into the diluent well (D) immediately. See illustration below. |
| 4 | Start the timer. |
| 5 | Wait for the colored line(s) to appear. Read test results at 15 minutes. Positive results maybe visible in as short as 1 minute. Negative results must be confirmed at the end of the 20 minutes only. Do not interpret the result after 20 minutes. |
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
