Hepatitis C Virus Antibody Detection Kit
1. INTEDED USE
Diagnostic Kit for Hepatitis C Virus Antibody (Fluorescence Immunochromatographic Assay)is a fluorescence immunochromatographic assay for the quantitative 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 |
| Methodology | Fluorescence Immunochromatographic Assay |
| Sample Type | serum/plasma |
| Time to Result | 10-15mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485,CE,MHRA |
| MAIN KIT COMPONENTS: *Test device *solution *Instructions for Use |
Packing: *25 test /kit *Aluminum foil bag labeling *shrink wrap |
3.TEST METHOD
| 1 | Read the instruction for use and test operation manual completely before the test and restore the reagent to room temperature before the test. Do not perform the test without restoring the reagent to room temperature to avoid affecting the accuracy of the test results. |
| 2 | Select standard test mode of WIZ-A101 portable immune analyzer |
| 3 | Open the aluminum foil bag package of reagent, and take out the test device; |
| 4 | Horizontally insert the test device into the slot of immune analyzer; |
| 5 | On home page of operation interface of immune analyzer, click “Standard” to enter test interface; |
| 6 | Click “QC Scan” to scan the QR code on inner side of the kit; input kit related parameters into instrument, and select sample type; Note: Each batch number of the kit shall be scanned for one time. If the batch number has been scanned, then skip this step; |
| 7 | Check the consistency of “Product Name”, “Batch Number” etc. on test interface with information on the kit label; |
| 8 | Add 10μL serum or plasma sample into sample diluent, and mix well.Add 80μL sample solution to sample well of the card. |
| 9 | After complete sample addition, click “Timing” and remaining test time will be automatically displayed on the interface. |
| 10 | Immune analyzer will automatically complete test and analysis when test time is reached. |
| 11 | Result calculation and display After test by immune analyzer is completed, test result will be displayed on test interface or can be viewed through “History” on home page of operation interface. |
4.Product Performance
| Linearity | 0.005-5 | relative deviation:-15% to +15%. |
| Linear correlation coefficient:(r)≥0.9900 | ||
| Accuracy | The recovery rate shall be within 85% - 115%. | |
| Repeatability | CV≤15% | |
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
