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Accu-Tell® HBsAg Elisa Test Kit

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Accu-Tell® HBsAg Elisa Test Kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative detection of HBsAg in human serum or plasma. It is intended for screening of blood donors and for diagnosing of patients related to infection with hepatitis B virus.
Product Description

CATALOG

Product NameSpecimenCatalog No.Quantity per box
HBsAg Elisa TestSerum/PlasmaABT-EIA-F196T


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 plateone
2. Negative Control1x1ml
3. Positive Control1x1ml
4. HRP-Conjugate1x7ml
5. Wash Buffer1x30ml
6. Chromogen Solution A1x8ml
7. Chromogen Solution B1x8ml
8. Stop Solution1x8ml


SUMMARY OF THE ASSAY PROCEDURE

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

Add Samples / Controls50ml
Add HPR-Conjugate50ml
Incubate60minutes
Wash5times
Coloring50ml   A + 50ml   B
Incubate15minutes
Stop the reaction50ml   stop solution
Read the absorbance450nm or 450/630 nm


INTENDED USE

ACCU-TELL® HBsAg ELISA is an enzyme-linked immunosorbent assay (ELISA) for qualitative detection of HBsAg in human serum or plasma. It is intended for screening of blood donors and for diagnosing of patients related to infection with hepatitis B virus.

 

PERFORMANCE CHARACTERISTICS

Clinical Specificity:

The clinical specificity of this assay was determinate by a panel of samples obtained from 2500 healthy blood donors and 300 undiagnosed hospitalized patients. The repeatedly reactive samples and samples confirmed positive with the reference test were not included in the calculation of specificity.

Sample   sourceNumber of Sample-+ ConfirmedPositiveSpecificityFalse   Positive
Donors25002444565399.87%3
Patients300273272699.63%1

Clinical Sensitivity:

The clinical sensitivity of ACCU-TELL® HBsAg ELISA was calculated by a panel of samples obtained from 670 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 HBsAg ELISA test was used as a confirmatory assay. The evaluation results are given below. Results obtained in individual laboratories may differ.

Clinical   HistoryNumber of Sample-+ConfirmedpositiveSensitivityFalse   Negatives
Acute2000200200100%0
Chronic400139940099.75%1
Recovery706555100%0

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.

No high dose hook effect up to HBsAg concentrations of 200000ng/ml observed during clinical testing.

Frozen specimens have been tested too to check for interferences due to collection and storage.

Analytical Endpoint Sensitivity (lower detection limit):

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 at the Cut-off of 0.5ng/ml (adr) and 0.5ng/ml (adw, ay).

 

LIMITATIONS

1. Positive results must be confirmed with another available method and interpreted in conjunction with the patient clinical information.

2. Antigens may be undetectable during the early stage of the disease. Therefore, negative results obtained with ACCU-TELL® HBsAg ELISA are only indication that the sample does not contain detectable level of hepatitis B virus surface antigen and any negative result should not be considered as conclusive evidence that the individual is not infected with HBV or the blood unit is not infected with HBV.

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® HBsAg ELISA has been evaluated only with individual serum or plasma specimens.

7. ACCU-TELL® HBsAg ELISA is a qualitative assay and the results cannot be used to measure antigen concentration.

 

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