Intended Use
The Human Anti-Tuberculosis (BCG) IgM ELISA Kit is an immunoassay suitable for quantifying IgM antibody activity specific for BCG in serum or plasma of vaccinated, immunized, and/or infected hosts.
This immunoassay is suitable for:
1. Determining immune status relative to non-immune controls
2. Assessing efficacy of vaccines, including dosage, adjuvantcy, route of immunization, and timing
3. Qualifying and standardizing vaccine batches & protocols
The assay is for research use only (RUO) and is not intended nor validated for diagnosing Tuberculosis disease.
Contents of Kit
1. Wash Solution Concentrate (100×), 10ml.
2. Sample Diluent Concentrate (20×), 10ml
3. Anti-Human IgM-HRP Conjugate Concentrate (100×), 0.15ml
4. BCG Coated Strip Plate, 8-well strips (12). Coated with purified BCG antigen and post-coated with stabilizers.
5. Anti-BCG Calibrators, Three (3) vials each containing anti-BCG; in buffer with antimicrobial as stabilizers.
3 U/ml, 0.65 ml
10 U/ml, 0.65 ml
30 U/ml, 0.65 ml
6. Anti-BCG Positive Control, 0.65 ml. Anti-BCG; in buffer with antimicrobial as stabilizers. [Value range is on the label]
7. TMB Substrate, 12 ml, Chromogenic substrate for HRP containing TMB and peroxide.
8. Stop Solution, 12 ml, Dilute sulfuric acid.
Storage
The microtiter well plate and all other reagents, if unopened, are stable at 2-8°C until the expiration date printed on the box label.
Sensitivity
The BCG-coated plate and Anti-Human IgM HRP concentration are optimized to differentiate anti-BCG IgM from background (non-antibody) signal with human serum samples diluted 1:100.
General Description
Mycobacterioses (tuberculosis, leprosy, atypical mycobacterioses, paratuberculosis, and perhaps Crohn's Disease) are diseases of humans and animals with the largest diffusion on earth. The infectious agents of tuberculosis are acid-resistant rod-like bacteria of the family Mycobacteriaceae, genus Mycobacterium. The main cause of TB is Mycobacterium tuberculosis which is a small, aerobic, nonmotile bacillus. The high lipid content of this pathogen accounts for many of its unique clinical characteristics. If a Gram stain is performed, MTB either stains very weakly "Gram-positive" or does not retain dye as a result of the high lipid and mycolic acid content of its cell wall. The only currently available vaccine as of 2012 is bacillus Calmette–Guérin (BCG with live attenuated bacteria) which, while it is effective against disseminated disease in childhood, confers inconsistent protection against contracting pulmonary TB. Nevertheless, it is the most widely used vaccine worldwide with more than 90% of all children being vaccinated.
A number of new TB vaccines are currently in phase I and II clinical trials. MVA85A (modified vaccinia Ankara 85A, Oxford University) is a subunit vaccine to BCG, which uses the attenuated MVA as a vaccine delivery platform to present antigen 85A to the immune system.
BCG vaccines: Pacis® BCG, made from the Montréal (Institut Armand-Frappier) strain (Dianon/Urocor). BCG vaccine Danish strain 1331 (Statens Serum Institut, Denmark), Tokyo BCG TY-1002, Tokyo 172 substrain of Pasteur BCG (Japan, BCG Labs), Moscow BCG 254-2; BCG vaccine Glaxo 1077 strain (Sanofi). All vaccine use attenuated M. Bovis strains.
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