The KaiBiLiTM Mycoplasma pneumoniae Antigen Rapid Test is an in vitro diagnostic test based on the principle of immuno-chromatography for the qualitative detection of Mycoplasma Pneumoniae (M. pneumoniae) antigens in human throat swab samples.
Introduction
Mycoplasma pneumoniae is a common respiratory pathogen that produces diseases of varied severity ranging from mild upper respiratory tract infection to severe atypical pneumonia. Although rarely fatal, M.pneumoniae is an important cause of acute respiratory tract infection, especially as a potential etiology of the clinical entity termed “atypical pneumonia”. Of the many species of Mycoplasma known to infect man, M. pneumoniae is an important cause of respiratory tract infections.
M. pneumoniae is the smallest, self-replicating microorganism biologically classified as a bacterium. However, it is distinguished from bacterium by the lack of cell wall structure.
The clinical presentation of M. pneumoniae respiratory disease is often similar to what is seen with other atypical pathogens, particularly Chlamydia pneumoniae, various respiratory viruses and bacteria. Typical clinical features include an initial pharyngitis, sore throat and hoarseness, fever. It is indistinguishable from the common cold, a factor that often delays diagnosis and treatment. Mycoplasma pneumonia affects pre-dominantly preschool and school-age children and young adults.
The test kit is to qualitatively detect M. pneumoniae antigen from the specimen without requiring special skills or instruments.