IVD Quality Control/Calibrator Raw Material: Chlamydia pneumoniae IgM

Chlamydia pneumoniae (CP) is a type of obligate intracellular parasite with a unique biphasic developmental cycle, and is one of the common respiratory pathogens. Its infection can be related to the onset of asthma, coronary heart disease and atherosclerosis, and the acute attack and exacerbation of chronic obstructive pulmonary disease. In addition, it can lead to vascular endothelial damage, junctional changes, and blood-brain barrier damage, etc., often involved in the central nervous system (CNS) disease occurrence and development. Due to the variability of clinical symptoms of Chlamydia pneumoniae infection, it is impossible to make a definite diagnosis solely by clinical symptoms or imaging. Therefore, laboratory diagnostics play an important role. Serological antibody detection is currently an important means of auxiliary diagnosis of Chlamydia pneumoniae pneumonia, and it is widely used in chemiluminescence, enzyme-linked immunoassay and immunochromatography. Chlamydia pneumoniae IgM plays an important role in in vitro diagnosis as a positive quality control. At present, the positive control substance Chlamydia pneumoniae IgM is mostly prepared from collected high-value large samples of plasma. Due to the lack of positive resources due to the difficulty in collecting clinical high-value samples, large-scale preparation cannot be performed. Humanized monoclonal antibody technology has many advantages such as high specificity, high affinity, small batch-to-batch variation, industrial mass production, and stable supply, and can solve the limitations of quality control materials and calibrators based on plasma or serum sources.