SUMMARY AND EXPLANATION THE TEST
Chlamydia pneumoniae (C. pneumoniae) is a common species of bacteria and a major cause of pneumonia around the world. Approximately 50% of adults have evidence of past infection by age 20, and reinfection later in life is common. Many studies have suggested a direct association between C. pneumoniae infection and other inflammatory diseases such as atherosclerosis,acute exacerbations of COPD,and asthma.
Diagnosis of C. pneumoniae infection is challenging due to the fastidious nature of the pathogen, the considerable seroprevalence, and the possibility of transient asymptomatic carriage. Established diagnostic laboratory methods include isolation of the organism in cell culture,serological assays and PCR.Microimmunofluorescence test (MIF), is the current “gold standard” for serological diagnosis, but the assay still lacks standardization and is technically challenging. Antibody immunoassays are the most common serology tests used and primary chlamydial infection is characterized by a predominant IgM response within 2 to 4 weeks and a delayed IgG and IgA response within 6 to 8 weeks. However, in reinfection, IgG and IgA levels rise quickly, often in 1-2 weeks whereas IgM levels may rarely be detected. For this reason, IgA antibodies have shown to be a reliable immunological marker of primary, chronic and recurrent infections especially when combined with the detection of IgM.
PRINCIPLE
Chlamydia pneumoniae IgG/IgM Rapid Test kit is based on the principle of a qualitative immunochromatographic assay for the determination of Chlamydia pneumoniae IgG/IgM antibody in the in human serum, plasma or whole blood.StripA consists of: 1) a burgundy colored conjugate pad containing C. pneumoniae antigen conjugated with colloid gold (C. pneumoniae Antigen conjugates), 2) a nitrocellulose membrane strip containing a test band (T band) and a control band (C band). The T band is pre-coated 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 C. pneumoniae antigen conjugated with colloid gold (C. pneumoniae Antigen conjugates), 2) a
nitrocellulose membrane strip containing a test band (T band) and a control band (C band). The T band is pre-coated 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.C. pneumoniae IgG antibody if present in the specimen will bind to the C. pneumoniae 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 C. pneumoniae 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 IgGgold 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.C. pneumoniae IgM antibody if present in the specimen will bind to the C. pneumoniae 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 C. pneumoniae 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 IgGgold conjugate regardless of the presence of colored T band. Otherwise, the test result is invalid and the specimen must be retested with another device.
