Accu-Tell^® HBsAb Elisa Test Kit

Product Description

CATALOG

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- inter changeable.

SUMMARY OF THE ASSAY PROCEDURE

Use this summary only as a reference and always follow the detailed method sheet when performing the assay.

INTENDED USE

ACCU-TELL^® HBsAb ELISA Test Kit is an enzyme linked immunosorbent assay (ELISA) for in vitro qualitative detection of antibodies to hepatitis B virus surface antigen (anti-HBs) in human serum or plasma. It is intended for use in medical laboratories for diagnosis and management of patients related to infection with hepatitis B virus.

PERFORMANCE CHARACTERISTICS

Analytical Endpoint Sensitivity (lower detection limits):

The assay shows sensitivity near the Cut-off of 5mIU/ml.

Clinical Specificity:

The clinical specificity of the assay has been determinate by a panel of samples obtained from 1500 healthy blood donors and 250 undiagnosed hospitalized patients.

Clinical Sensitivity:

The clinical sensitivity of the assay has been calculated by a panel of samples obtained from 580 hepatitis B patients with well-characterized clinical history based upon reference assays for detection of HBsAg, HBeAg, anti-HBs, anti-HBe, and anti-HBc. Licensed anti-HBs ELISA test was applied as a confirmatory assay. For establishing the test performance characteristics during monitoring of post-vaccination antibody response, additional group of samples from 200 individuals receiving HBV vaccine was tested for anti-HBs.

Analytical Specificity:

No cross reactivity observed with samples from patients infected with HAV, HCV, HIV, CMV and TP.

No interference was observed from rheumatoid factors up to 2000U/ml.

The assay performance characteristics are unaffected from elevated concentrations of bilirubin, hemoglobin, and triolein.

No high dose hook effect up to 150000mIU/ml.

Frozen specimens have been tested too 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. In very rare cases some HBV mutants or subtypes can remain undetectable. A negative result with an antibody detection test does not preclude the possibility of infection.

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 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.