Accu-Tell^® HBsAb Elisa (Quantitative) 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^® Anti-HBs ELISA (Quantitative) Kit is an enzyme linked immunosorbent assay (ELISA) for in vitro quantitative determination of antibodies to hepatitis B virus surface antigen (anti-HBs) in human serum or plasma for clinical purposes and assessing antibody response levels to HBsAg-vaccine.

PERFORMANCE CHARACTERISTICS

This kit was standardized against Reference Standards from the Reference Laboratory for Immunology Product under the Ministry of Health, China.

Analytical Sensitivity (lower detection limit):In the follow-up of vaccinated individuals the value of 10 WHO mIU/ml is the minimum concentration at which the recipient is considered protected. This kit shows sensitivity of 5mIU/ml.

Clinical Sensitivity: The performance characteristics of this assay were evaluated by a panel of samples obtained from 600 individuals receiving HBV vaccines in which the titers of anti-HBs were evaluated in a direct comparison with another commercially available ACCU-TELL^® Anti-HBs ELISA (Quantitative) Kit. From this group, 594 individuals showed antibody titer higher than 10mIU/ml, which was confirmed with the reference ACCU-TELL^® Anti-HBs ELISA (Quantitative) Kit. In another group of 220 individuals with confirmed hepatitis B vaccination history, 220 of the tested samples showed antibody titer higher than 10mIU/ml. From this study, overall agreement of 100% was obtained between this kit and the reference test in linear regression analysis.

In a panel of 240 samples obtained from early recovery hepatitis B patients (confirmed HBsAg -, anti-HBc+ and anti-HBs+), sensitivity of 100% was calculated in comparison with the reference test.

Specificity:> 99% calculated by a panel of samples obtained from 500 healthy individuals with confirmed levels of anti-HBs less than 10mIU/ml.

No cross reactivity observed when testing samples from patients infected with HAV, HCV, HIV, CMV, and TP. No interference from elevated levels of rheumatoid factors up to 2000U/ml. No high dose hook effect up to 150000mIU/ml observed during clinical testing. The kit 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.

Recovery:

LIMITATIONS

1. Non- repeatable reactive results may be obtained with any ELISA test due to the general characteristics of this method. Any positive result must be interpreted in conjunction with the patient clinical information and other laboratory results.

2. 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.

3. Common sources for mistakes: kits beyond the expiry date, bad washing procedures, contaminated reagents, incorrect assay procedure steps, insufficient aspiration during washing, failure to add samples or reagents, equipment, timing, volumes, sample nature and quality.

4. The prevalence of the marker will affect the assay’s predictive values.

5. In some cases, very strong immunological response after vaccination can be observed due to the vaccine biological characteristics. High concentrations of antibodies beyond the standard curve measurement range (>160mIU/ml) can be diluted and retested. Samples may not show linear properties after dilution as the same way as the materials used for the standards. This phenomenon is frequently observed when samples are tested for antibodies.

6. Samples tested using assay from different manufacturer can give similar quantitative results but some samples can give discrepancies due to the antibodies diversity and the antigenic properties of HBsAg used in the assay.

7. 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.

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.