Mycobacterium Tuberculosis IgG ELISA Kit (TB)

Full Name: Mycobacterium Tuberculosis IgG ELISA Kit (TB)
Reactivity: Human
Sample Type: Serum, Plasma
Sensitivity: 1.09 U/ml

BACKGROUND

Mycobacterium tuberculosis (TB) is an obligate pathogenic bacterial species, which is a non-spore forming, gram negative bacterium containing a lipid rich thick cell wall. It is part of a complex that consists of at least 9 other species: M. africanum, M. bovis, M. microti, M. orygis, M. mungi, M. pinnipedii, M. canetti, M. caprae and M. tuberculosis sensu strictu. M. tuberculosis is able to divide every 15-20 hours, this is considered to be extremely slow in comparison to other bacteria (for example Escherichia coli divides every 20 minutes). The target for the infection is mainly the lungs, however, other organs such as the brain, kidneys, intestinal tract, lymph nodes and bones can also be afflicted.

Any usual diagnostic procedures have proved to be unsatisfactory and are unable to distinguish between the different mycobacterial species. Also, until recently, there serological methods which made it possible to detect tuberculosis antibodies in serum. The following assay procedure can be used to measure IgG antibodies using a cocktail of highly pure proteins in order to analyse the immune response against the bacteria.

INTENDED USE

Human mycobacterium tuberculosis IgG ELISA kit is intended for detecting in-vitro levels of human IgG antibodies against mycobacterium tuberculosis (mycobacterium-IgG) using serum and plasma. This assay has a minimum analytical sensitivity limit of 1.09 U/ml.

CONTENT

All reagents supplied need to be stored at 2 °C – 8 °C, unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.

Mycobacterium tuberculosis antigen coated microtiter strips.
Negative Control (Calibrator A).
Positive Control (Calibrator D).
Cut-Off Standard (Calibrator B).
Weak Positive Control (Calibrator C).
Enzyme Conjugate.
Sample Diluent.
TMB Substrate.
Washing Buffer (10x).
Stop Solution.

SENSITIVITY

The minimum detection sensitivity level of human IgG antibodies to mycobacterium tuberculosis using current mycobacterium IgG ELISA kit was 1.09 U/ml. The dynamic range for this assay is 1.0 – 150.0 U/ml.

ASSAY CHARACTERISTICS

– Intra-Assay-Precision: 7.6 %
– Inter-Assay-Precision: 9.4 %
– Inter-Lot-Precision: 3.1 – 9.9 %
– Analytical Sensitivity: 1.09 U/mL
– Recovery: 86 – 95 %
– Linearity: 82 – 113 %
– Cross-Reactivity: No cross-reactivity to Helicobacter pylori and Bordetella pertussis.
– Interferences: No interferences to triglycerides up to 5.0 mg/mL, bilirubin up to 0.3 mg/mL and hemoglobin up to 8.0 mg/mL.
– Clinical Specificity: 99 %
– Clinical Sensitivity: 100 %

REFERENCES

Antituberculosis IgG antibodies as a marker of active Mycobacterium tuberculosis disease. Clin Vaccine Immunol. (2012) 19 (4): 522-6. Welch R.J., et al.
High levels of anti-tuberculin (IgG) antibodies correlate with the blocking of T-cell proliferation in individuals with high exposure to Mycobacterium tuberculosis. Int J Infect Dis. (2016) 43: 21-4. Feris E.J., et al.
Macrophages are needed in the progression of tuberculosis into lung cancer. Tumour Biol. (2015) 36 (8): 6063-6. Li J., et al.
Dynamic IgG antibody response to immunodominant antigens of M. tuberculosis for active TB diagnosis in high endemic settings. Clin Chim Acta. (2016) 461: 25-33. Pathakumari B., et al.

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