Mycoplasma Pneumoniae IgM ELISA Kit

Full Name: Mycoplasma Pneumoniae IgM ELISA Kit
Reactivity: Human
Sample Type: Serum, Plasma
Sensitivity: 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.

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.

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

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.
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.
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.
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.
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.

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