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Products

TB IgG Antibody ELISA Test
Tuberculosis IgG Antibody ELISA Test

Catalog No.      Product Name

ABT-EIA- F33    Tuberculosis IgG Antibody ELISA Test


INTENDED USE

ACCU-TELL® Tuberculosis IgG Antibody ELISA kit is an enzyme-linked immunosorbent assay for qualitative detection of IgG antibodies to Mycobacterium tuberculosis in human serum or plasma. It is intended for diagnosing and monitoring of patients related to infection by M. tuberculosis or other Mycobacteria.


PERFORMANCE CHARACTERISTICS

1. Sensitivity / Specificity

553 samples from TB patients and 1650 samples from healthy people were tested with this ELISA kit, the results are as follows:

Sample Source

Sample Number

+

-

Sensitivity

Specificity

TB patients

553

369

184

66.7%

-

Healthy people

1650

65

1585

-

96.1%

2. No cross reactivity was observed with the samples of antibody positive to HIV, HAV-IgM, HBV, HCV, TP and HTLV.

3. Common interference factors, e.g.mild hemolysis, hyperlipidemia, jaundice, rheumatoid factor and ALT elevation, will not cause false positive.

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 ELISAkit are only indication that the sample does not contain detectable level of IgG antibodies to TB and any negative result should not be considered as conclusive evidence that the individual is not infected with MTB.

  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.