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HAV-Ab ELISA Test
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HAV-Ab ELISA Test

Catalog No.      Product Name

ABT-EIA- F9      HAV-Ab ELISA Test

INTENDED USE

 ACCU-TELL® HAV-Ab ELISA is an enzyme linked-immunosorbent assay (ELISA) for qualitative detection of total antibodies to hepatitis A virus in human serum or plasma. It is intended for use in clinical laboratories for diagnosis and monitoring of patients related to infection with hepatitis A virus, and/or for monitoring of hepatitis A vaccine recipients

PERFORMANCE CHARACTERISTICS

The clinical sensitivity of this kit has been determinated by testing samples obtained from 2432 (1092 children and 1410 adults) individuals suspected for infection with HAV or recovered after outcome. Another group of samples obtained from 2180 healthy individuals was tested to determinate the clinical specificity of the assay. These studies were carried out in direct comparison with another commercially available anti-HAV ELISA kit used as a confirmation assay. The evaluation results are given below:

Clinical Sensitivity:

 

Children

Sensitivity

Tested

-

+

Confirmed

Inapparent Infection

358

8

350

350

100%

Anicteric / Icteric

234

184

50

50

100%

Complete Recovery

500

0

500

500

100%

Total

1092

192

900

900

100%

 

 

Adults

Sensitivity

Tested

-

+

Confirmed

Inapparent Infection

300

233

67

67

100%

Anicteric / Icteric

540

60

480

480

100%

Complete Recovery

570

0

570

570

100%

Total

1410

293

1117

1117

100%

Clinical Specificity:

 

Children

Adults

Number of Sample

Specificity

False Positive

Number of Sample

Specificity

False Positive

Healthy Individuals

1300

>99%

4

880

>99%

5


Follow-up after vaccination with hepatitis A vaccine:

Time after receiving the first dose (months)

A Value

0

2.451

2

0.432

4

0.375

6 second dose (booster)

0.142

14 third dose (booster)

0.025

Analytical Specificity:

No cross reactivity observed with samples from patients confirmed to be infected with HBV, HCV, HIV, CMV, and TP. No interferences from elevated levels of 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 this HAV-Ab ELISA are only indication that the sample does not contain detectable level of anti-HAV antibodies and any negative result should not be considered as conclusive evidence that the individual is not infected with HAV.

  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.