Mycoplasma Pneumoniae IgM ELISA Kit

INTENDED USE

Human Mycoplasma pneumoniae IgM ELISA kit can be used for analysing in-vitro levels of human IgM antibodies against Mycoplasma pneumoniae (Mycoplasma-IgM) using samples of plasma or serum. This assay has a minimum analytical sensitivity limit of 1.22 U/ml.

BACKGROUND

Mycoplasma pneumoniae belong to a class of Mollicutes and are able to form atypical bacterial pneumonia which is related to cold agglutinin disease. Mycoplasmas are essentially the smallest self-replicating organisms which contain no cell wall or periplasmic space, have limited metabolic activity and conatin a reduced genome.

M. pneumoniae infections are commonly found to cause acute respiratory infections in either children or adults. The cells are typically composed of elongated shapes that are between 100-200 nm in width and 1000-2000 nm in length. Early diagnosis is difficult since there are only a limited number of unusual symptoms. As Mycoplasma pneumoniae progresses then imaging and many other laboratory tests can be used detect it.

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.

• Mycoplasma pneumoniae 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 Mycoplasma pneumoniae using current Mycoplasma IgM ELISA kit was 1.22 U/ml. The dynamic range for this assay is 1.0 – 125.0 U/ml.

ASSAY CHARACTERISTICS

– Intra-Assay-Precision: 7.9 %
– Inter-Assay-Precision: 8.0 %
– Inter-Lot-Precision: 5.1 – 12.5 %
– Analytical Sensitivity: 1.22 U/mL
– Recovery: 91 – 116 %
– Linearity: 70 – 106 %
– Cross-Reactivity: No cross-reactivity to Parainfluenza, RSV, Adenovirus and Influenza.
– Interferences: No interferences to, hemoglobin up to 8.0 mg/mL, triglycerides up to 5.0 mg/mL and bilirubin up to 0.3 mg/mL.
– Clinical Specificity: 92 %
– Clinical Sensitivity: 100 %

REFERENCES

1. Human monoclonal IgMs with anti-Mycoplasma pneumoniae antibody activity. Arch Inst Pasteur Tunis. (2003) 80 (1-4): 3-8. Ben Aissa-Fennira F., et al.
2. Diagnosis of Mycoplasma pneumoniae-infection by specific IgM antibodies using a new capture-enzyme-immunoassay. Eur J Epidemiol. (1993) 9 (1): 97-9. Samra Z. and Gadba R.
3. High seroprevalence of Mycoplasma pneumoniae IgM in acute Q fever by enzyme-linked immunosorbent assay (ELISA). PLoS One. (2013) 8 (10): e77640. Lai C.H., et al.
4. Asthmatic children have increased specific anti-Mycoplasma pneumoniae IgM but not IgG or IgE-values independent of history of respiratory tract infection. Pediatr Infect Dis J. (2013) 32 (6): 599-603. Smith-Norowitz T.A., et al.
5. Immunoregulatory role for a public IgM idiotype in the induction of autoimmune diseases in Mycoplasma pneumoniae infection. Immunol Lett. (2011) 136 (2): 130-7. Ben Aissa-Fennira F., et al.

ADDITIONAL INFORMATION

• Full Name: Mycoplasma Pneumoniae IgM ELISA Kit
• Reactivity: Human
• Sample Type: Serum, Plasma
• Sensitivity: 1.22 U/ml

OTHER RELATED ELISA KITS

• Mycoplasma Pneumoniae-IgG ELISA Kit
• Aspergillus Fumigatus-IgM ELISA Kit
• Echinococcus Granulosus-IgG ELISA Kit