Uncut sheet for IgM Antibody to C.Pneumoniae CPn-IgM

The Chlamydia pneumoniae Antibody Rapid Test Device (the “uncut sheet” format for manufacturing use) is a rapid immunochromatographic assay intended for the qualitative detection of antibodies (IgM, and/or IgG) to Chlamydia pneumoniae in human serum, plasma, or whole blood specimens.

This test is intended for in vitro diagnostic professional use and serves as an aid in the diagnosis of Chlamydia pneumoniae infection in patients presenting with clinical signs and symptoms suggestive of respiratory tract infection, such as community-acquired pneumonia, acute bronchitis, pharyngitis, and sinusitis.

The device provides presumptive screening results . Results should be interpreted as follows:

• IgM positive: suggests recent or acute infection, as IgM antibodies appear within 2–4 weeks after primary infection .
• IgG positive, IgM negative: suggests past exposure or resolved infection, as IgG antibodies persist for long periods .
• IgM and IgG negative: does not rule out infection, particularly if the specimen is collected during the early stage of infection when antibody levels may be below the detection limit 

Negative results do not exclude C. pneumoniae infection, especially if the sample is taken before seroconversion or in cases of reinfection where IgM may not be produced . Positive results are preliminary, results obtained shall be used incombination with other clinical information for analysis.

This product is intended for use by trained healthcare professionals or laboratory personnel. This product is for manufacturing use only and is intended for further processing into final device format.