SUMMARY AND EXPLANATION THE TEST
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 theduration 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
Mycoplasma Pneumoniae IgG/IgM Rapid Test Kit based on the principle of a qualitative immunochromatographic assay for the determination of Mycoplasma Pneumoniae IgG/IgM antibody in the in human serum, plasma or whole blood.StripA consists of: 1) a burgundy colored conjugate pad containing MP antigen conjugated with colloid gold (MP Antigen conjugates), 2) a nitrocellulose membrane strip containing a test band (T band) and a control band (C band). The T band is precoated with mouse anti-human IgG antibody, and the C band is pre-coated with goat anti-mouse IgG antibody. Strip B consists of : 1) a burgundy colored conjugate pad containing MP antigen conjugated with colloid gold (MP Antigen conjugates), 2) a nitrocellulose membrane strip containing a test band (T band) and a control band (C band). The T band is precoated with mouse anti-human IgM antibody, and the C band is pre-coated with goat anti-mouse IgG antibody.
Strip A:When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette.MP IgG antibody if present in the specimen will bind to the MP Antigen conjugates. The immunocomplex is then captured on the membrane by the pre-coated Mouse anti-human IgG antibody, forming a burgundy colored T band, indicating a MP IgG positive test result. Absence of the T band 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-mouse IgG/mouse IgG-gold conjugate regardless of the presence of colored T band. Otherwise, the test result is invalid and the specimen must be retested with another device.
Strip B:When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette.MP IgM antibody if present in the specimen will bind to the MP Antigen conjugates. The immunocomplex is then captured on the membrane by the pre-coated Mouse anti-human IgM antibody, forming a burgundy colored T band, indicating a MP IgM positive test result. Absence of the T band 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-mouse IgG/mouse IgG-gold conjugate regardless of the presence of colored T band. Otherwise, the test result is invalid and the specimen must be retested with another device.
