Accu-Tell® HBcAb IgM Elisa Test Kit
Product Description
CATALOG
| Product Name | Specimen | Catalog No. | Quantity per box |
| HBcAb IgM Elisa Test | Serum/Plasma | ABT-EIA-F10 | 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 | 1x0.5ml |
| 3. Positive Control | 1x0.5ml |
| 4. HRP-Conjugate | 1x12ml |
| 5. Wash Buffer | 1x30ml |
| 6. Chromogen Solution A | 1x7ml |
| 7. Chromogen Solution B | 1x7ml |
| 8. Stop Solution | 1x7ml |
SUMMARY OF THE ASSAY PROCEDURE:
Use this summary only as a reference and always follow the detailed method sheet when performing the assay.
| Dilute samples with normal saline | 1:1000 |
| Add Samples / Controls | 100ml |
| Incubate | 30minutes |
| Wash | 5times |
| Add HPR-Conjugate | 100ml |
| Incubate | 30minutes |
| Wash | 5times |
| Coloring | 50ml A + 50ml B |
| Incubate | 15minutes |
| Stop the reaction | 50ml stop solution |
| Read the absorbance | 450nm or 450/630 nm |
INTENDED USE
ACCU-TELL® HBcAb-IgM ELISA is an enzyme-linked immunosorbent assay (ELISA) for qualitative determination of IgM class antibodies to hepatitis B virus core antigen in human serum or plasma. It is intended for use in clinical laboratories for diagnosis and management of patients related to infection with hepatitis B virus.
PERFORMANCE CHARACTERISTICS
Analytical Endpoint Sensitivity: The sensitivity of the assay has been calculated by means of the reference standards provided from the Reference Laboratory for Immunology Product under the Ministry of Health, China. The assay shows sensitivity near the Cut-off of 1 NCU (National Current Unit, MOH, China).
The clinical specificity of this assay has been determinate by a panel of samples obtained from 2500 healthy blood donors and 230 undiagnosed hospitalized patients. The repeatedly reactive samples and samples confirmed positive with the reference test were not included in the calculation of specificity.
| Specificity | Number of Samples | - | + | ConfirmedPositive | Specificity | False Positive |
| Donors | 2500 | 2492 | 8 | 5 | 99.87% | 3 |
| Patients | 230 | 210 | 20 | 20 | 100% | 0 |
| Total | 2730 | 2702 | 28 | 25 | 99.93% | 3 |
The clinical sensitivity of this kit has been calculated by a panel of samples obtained from 548 hepatitis B patients with well-characterized clinical history based upon reference assays for detection of HBsAg, anti-HBs, HBeAg, anti-HBe, and anti-HBc. This panel included samples from acute, chronic and recovered hepatitis B patients. Licensed anti-HBc IgM ELISA test was used as a confirmatory assay. The evaluation results are given below.
| Sensitivity | Number of Samples | - | + | ConfirmedPositive | Sensitivity | False Negative |
| Acute | 318 | 4 | 314 | 315 | 99.68% | 1 |
| Chronic | 128 | 110 | 18 | 18 | 100% | 0 |
| Total | 446 | 113 | 332 | 333 | 99.84% | 1 |
| Recovery | 102 | 101 | 1 | 1 | 100% | 0 |
Marker prevalence in follow up of patients infected with HBV:
| Days SinceInfection | Number ofSamples | + | - | Detected Prevalence of anti-HBc IgM |
| 0 | 10 | 2 | 8 | 20% |
| 1-10 | 12 | 3 | 8 | 25% |
| 11-20 | 13 | 4 | 7 | 30% |
| 21-30 | 9 | 8 | 1 | 88% |
| 31-50 | 9 | 9 | 0 | 100% |
| 51-70 | 14 | 14 | 14 | 100% |
| 71-100 | 11 | 11 | 11 | 100% |
| 101-120 | 8 | 8 | 8 | 100% |
| 121-150 | 3 | 3 | 3 | 100% |
| 151-170 | 2 | 1 | 1 | 50% |
| 171-200 | 1 | 0 | 1 | 0% |
| Total: | 92 | 63 | 29 | 68.48% |
Analytical Specificity:
No cross reactivity observed with samples from patients infected with HAV, HCV, HIV, CMV, TP, and HTLV.
No interferences from rheumatoid factors up to 2000U/ml were observed during clinical testing.
The assay performance characteristics are unaffected from elevated concentrations of bilirubin, hemoglobin, and triolein.
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® HBcAb-IgM ELISA are only indication that the sample does not contain detectable level of anti-HBc IgM.
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. For more information regarding ELISA Troubleshooting, please refer to “ELISAs and Troubleshooting Guide”, or contact technical support for further assistance.
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 kit is intended ONLY for testing of individual serum or plasma samples. Do not use it for testing of cadaver samples, saliva, urine or other body fluids, or pooled (mixed) blood.
7. This kit is a qualitative assay and the results cannot be used 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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