Immunochromatography test for rapid diagnosis of Mycoplasma pneumoniae Mycoplasma pneumoniae infection

摘要

Abstract The sensitivity and specificity of a new rapid Mycoplasma pneumoniae antigen immunochromatography ( IC ) test, DK ‐ MP ‐001, were determined using particle agglutination ( PA ) antibody response and loop‐mediated isothermal amplification ( LAMP ) gene detection as the gold standard. Of 165 patients, 59 were diagnosed with M. pneumoniae infection based on a ≥fourfold rise of serum PA antibody during the course of the illness. Of the first visit swabs, 60 were positive for M. pneumoniae on LAMP , and 49 were positive for M. pneumoniae antigen on IC test. Compared with PA antibody and LAMP , the sensitivity/specificity of the IC test were 81.4% (48/59) and 99.1% (105/106); and 81.7% (49/60) and 100% (105/105), respectively. IC test detected antigen in pharyngeal swabs more sensitively than in nasal swabs for the same subjects ( P? ? 0.05). The IC test performs well enough to be used with pharyngeal swabs at the first examination.