Accu-Tell^® HBeAb 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- interchangeable.

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^® HBeAb ELISA is an enzyme-linked immunosorbent assay (ELISA) for qualitative detection of antibodies to hepatitis B virus e antigen (anti-HBe) 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

Clinical Specificity:

The clinical specificity of this kit has been evaluated by a panel of samples obtained from 980 healthy blood donors and 270 undiagnosed hospitalized patients. Any positive results were confirmed with another commercially available anti-HBe ELISA kit. The repeatedly reactive samples and samples confirmed positive with the reference test were not included in the calculation of specificity.

Clinical Sensitivity:

To calculate the clinical sensitivity of the kit, a panel of sample obtained from 654 hepatitis B patients was used. Each patient clinical status was established based upon reference assays for detection of HBsAg, HBeAg, anti-HBs, anti-HBe, and anti-HBc.

Analytical Specificity:

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

No interference from rheumatoid factors up to 2000U/ml 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. In very rare cases some HBV mutants or subtypes can remain undetectable. Therefore, negative results obtained with anti-HBe ELISA are only indication that the sample does not contain detectable level of anti-HBe.

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.