Mycobacterium Tuberculosis IgM ELISA Kit (TB)

Full Name: Mycobacterium Tuberculosis IgM ELISA Kit (TB)
Reactivity: Human
Sample Type: Serum, Plasma
Sensitivity: 1.22 U/ml

BACKGROUND

Mycobacterium tuberculosis (TB) is a gram negative bacteria which is non spore forming and contains a thick lipid rich cell wall. It is unlike other bacteria where it can take anything from 15-20 hours to divide whereas Escherichia coli takes 20 minutes. At present there are at least nine different species that have been identified and the target for the infection is mostly the lungs, other organs which can also be affected include: the brain, intestinal tract and kidneys.

The following assay method is designed for measuring IgM antibodies using a cocktail of highly pure proteins which can allow the analysis of an immune response against the bacteria. Specific antigens are prepared either by purification of natural or by recombinant methods.

INTENDED USE

Human mycobacterium tuberculosis IgM ELISA kit is an in-vitro procedure for detecting human IgM antibodies against mycobacterium tuberculosis (mycobacterium-IgM) in plasma or serum samples. This assay has a minimum analytical sensitivity limit of 1.22 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.
• Enzyme Conjugate.
• Sample Diluent.
• TMB Substrate.
• Washing Buffer (10x).
• Stop Solution.
• Cut-Off Standard (Calibrator B).
• Positive Control (Calibrator D).
• Negative Control (Calibrator A).
• Weak Positive Control (Calibrator C).

SENSITIVITY

The minimum detection sensitivity level of human IgM antibodies to mycobacterium tuberculosis using current mycobacterium IgM ELISA kit was 1.22 U/ml. The dynamic range for this assay is 1.0 – 100.0 U/ml.

ASSAY CHARACTERISTICS

– Intra-Assay-Precision: 7.9 %
– Inter-Assay-Precision: 7.4 %
– Inter-Lot-Precision: 5.7 – 8.9 %
– Analytical Sensitivity: 1.22 U/mL
– Recovery: 87 – 91 %
– Linearity: 78 – 118 %
– Cross-Reactivity: No cross-reactivity to Bordetella pertussis and Helicobacter pylori.
– Interferences: No interferences to bilirubin up to 0.3 mg/mL, triglycerides up to 5.0 mg/mL and hemoglobin up to 8.0 mg/mL.
– Clinical Specificity: 100 %
– Clinical Sensitivity: 100 %

REFERENCES

1. Immunochromatographic IgG/IgM test for rapid diagnosis of active tuberculosis. Clin Vaccine Immunol. (2011) 18 (12): 2090-4. Ben-Selma W., et al.
2. Differential expression of immunogenic proteins on virulent Mycobacterium tuberculosis clinical isolates. Biomed Res Int. (2014) 2014: 741309. Schierloh P., et al.
3. Detection of IgM antibodies in pulmonary tuberculosis by ELISA using A60 antigen. J Commun Dis. (1996) 28 (3): 176-80. Mahajan M., et al.
4. Circulating immune complexes in pulmonary-tuberculosis. J Clin Lab Immunol. (1985) 18 (2): 91-5. Ashtekar M.D. and Samuel A.M.
5. Detection of serum antibodies in tuberculosis patients. Cent Eur J Public Health. (1994) 2 (1): 60-1. Jarosíková T, et al.

OTHER RELATED ELISA KITS

• Mycobacterium Tuberculosis-IgG ELISA Kit
• Mycoplasma Pneumoniae-IgM ELISA Kit
• Mycoplasma Pneumoniae-IgG ELISA Kit