Accu-Tell® HCV Elisa Test Kit
Product Description
CATALOG
| Product Name | Specimen | Catalog No. | Quantity per box |
| HCV Elisa Test | Serum/Plasma | ABT-EIA-F6 | 96T |
SUMMARY OF THE MAJOR COMPONENTS OF THE KIT
Use this summary only as a reference and always follow the comprehensive method sheet when performing the assay. Note: the components of individual kits are not lot- interchangeable.
| 1. Microwell plate | one |
| 2. Negative Control | 1x0.2ml |
| 3. Positive Control | 1x0.2ml |
| 4. HRP-Conjugate | 1x13ml |
| 5. Specimen Diluent | 1x13ml |
| 6. Wash Buffer | 1x50ml |
| 7. Chromogen Solution A | 1x8ml |
| 8. Chromogen Solution B | 1x8ml |
| 9. Stop Solution | 1x8ml |
SUMMARY OF THE ASSAY PROCEDURE
Use this summary only as a reference and always follow the detailed method sheet when performing the assay.
| Add Specimen Diluent | 100 µl |
| Add Samples | 10 µl |
| Incubate | 30 minutes |
| Wash | 5 times |
| Add HPR-Conjugate | 100 µl |
| Incubate | 30 minutes |
| Wash | 5 times |
| Coloring | 50 µl A + 50 µl B |
| Incubate | 15 minutes |
| Stop the reaction | 50 µl stop solutionµ |
| Read the absorbance | 450nm or 450/630 nm |
INTENDED USE
ACCU-TELL® HCV ELISA is an enzyme-linked immunosorbent assay (ELISA) for qualitative detection of antibodies to hepatitis C virus in human serum or plasma. It is intended for screening blood donors and diagnosing patients related to infection with hepatitis C virus.
PERFORMANCE CHARACTERISTICS
Clinical Specificity:
A blood donor population of 2948 individuals was tested with 3 different kits from different manufacturers. The specificity of ACCU-TELL® HCV ELISA was 99.55%.
Clinical Sensitivity:
Among 480 clinical hepatitis C patients confirmed positive by RIBA 3.0, 480 were positive when tested with ACCU-TELL® HCV ELISA. The sensitivity was 100%.
Analytical Specificity:
No cross reactivity observed with samples from patients infected with HAV, HBV, HIV, CMV and TP. No interference was observed from rheumatoid factors up to 2000U/ml.
The performance characteristics of this assay are unaffected from elevated concentrations of bilirubin, hemoglobin, and triolein.
Same day and frozen specimens have been tested to check for interferences due to collection and storage.
LIMITATIONS
1. Positive results must be confirmed with another available method and interpreted in conjunction with the patient clinical information.
2. Antibodies may be undetectable during the early stage of the disease and in some immunosuppressed individuals. Therefore, negative results obtained with ACCU-TELL® HCV ELISA are only indication that the sample does not contain detectable level of anti-HCV antibodies and any negative result should not be considered as conclusive evidence that the individual is not infected with HCV or the blood unit is not infected with HCV.
3. If, after retesting of the initially reactive samples, the assay results are negative, these samples should be considered as non-repeatable (false positive) and interpreted as negative. As with many very sensitive ELISA assays, false positive results can occur due to the several reasons, most of which are related but not limited to inadequate washing step.
4. The most common assay mistakes are: using kits beyond the expiry date, bad washing procedures, contaminated reagents, incorrect assay procedure steps, insufficient aspiration during washing, failure to add specimens or reagents, improper operation with the laboratory equipment, timing errors, the use of highly hemolyzed specimens or specimens containing fibrin, incompletely clotted serum specimens.
5. The prevalence of the marker will affect the assay’s predictive values.
6. This assay cannot be utilized to test pooled (mixed) plasma. ACCU-TELL® HCV ELISA has been evaluated only with individual serum or plasma specimens.
7. ACCU-TELL® HCV ELISA is a qualitative assay and the results cannot be use to measure antibodies concentrations.
Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.
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