INTENDED USE

The Mycoplasma Pneumoniae IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM antibody to Mycoplasma Pneumoniae in human serum, plasma or whole blood. It is intended to be used as a screening test and as an aid in the diagnosis of infection with L. interrogans. Any reactive specimen with the Mycoplasma Pneumoniae IgG/IgM Combo Rapid Test must be confirmed with alternative testing method(s).

SUMMARY

M. pneumoniae can cause a host of symptoms such as primary atypical pneumonia, tracheobronchitis, and upper respiratory tract disease. Tracheobronchitis is most common in children with a reduced immune system, and up to 18% of infected children require hospitalization. Clinically, M. pneumoniae cannot be differentiated from pneumonia caused by other bacteria or viruses. A specific diagnosis is important because treatment of M. pneumoniae infection with β-lactam antibiotics is ineffective, whereas treatment with macrolides or tetracyclines can reduce the duration of the illness.
Adherence of M. pneumoniae to the respiratory epithelium is the first step in the infection process. This attachment process is a complex event that requires several adhesin proteins, such as P1, P30, and P116. The true incidence of M. pneumoniae associated infection is not clear as it difficult to diagnose in the early stages of infection.

PRINCIPLE

The Mycoplasma Pneumoniae IgG/IgM Combo Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing recombinant Mycoplasma Pneumoniae antigens conjugated with colloid gold (Mycoplasma Pneumoniae conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing two test bands (M and G bands) and a control band (C band). The M band is pre-coated with monoclonal anti-human IgM for the detection of anti-Mycoplasma Pneumoniae IgM, G band is pre-coated with reagents for the detection of anti-Mycoplasma Pneumoniae IgG, and the C band is pre-coated with goat anti rabbit IgG.

When an adequate volume of test specimen is dispensed into the sample well of the cassette, the specimen migrates by capillary action across the cassette. IgM anti-Mycoplasma Pneumoniae if present in the specimen will bind to the Mycoplasma Pneumoniae conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM antibody, forming a burgundy colored M band, indicating a Mycoplasma Pneumoniae IgM positive test result.
IgG anti-Mycoplasma Pneumoniae if present in the specimen will bind to the Mycoplasma Pneumoniae conjugates. The immunocomplex is then captured by the pre-coated reagents on the membrane, forming a burgundy colored G band, indicating a Mycoplasma Pneumoniae IgG positive test result.
Absence of any test bands (M and G) suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the test bands. Otherwise, the test result is invalid and the specimen must be retested with another device.