Novice

Illumigene® Mycoplasma (REF. 280550)

Key-points summary:

Mycoplasma pneumoniae is a common cause of respiratory infections in humans, infecting the upper and the lower respiratory tracts in children and young adults:

·         the most common pathogen of lung infections in persons aged 4-35 years
·         known as a major cause of pneumonia (called primary atypical pneumonia and  walking pneumonia) accounting for the 15 to 20% of the cases of X-ray proven pneumonia; up to 5% of infected patients require hospitalization
·         causes up to 40 % of community-acquired pneumonia (CAP)
·         responsible for 18% of the hospitalizations in children
·         not a winter disease (late summer & autumn)
·         usually endemic, but responsible of epidemics at four-to-seven years intervals

Current Diagnostic Methods have limitations:

·         the gold standard for diagnosis should be Culture of respiratory specimens, but culturing this bacterium is labour intensive and time consuming, with a TAT of up to 3 weeks. Additionally, due to lack of standardization, culture often has a sensitivity lower than 60%
·         laboratory diagnosis is mostly based on serology (IgM & IgG), which has some limits
          o   in paediatric population IgM is an acceptable marker for acute infections allowing a diagnosis with one single serum determination, but it lacks of sensitivity in the early phase of the disease
          o   in adult population  IgM determination lacks of sensitivity, due to poor IgM seroconversion, while diagnosis based on IgG determination requires comparison of two serum titers with an interval of 3 weeks, thus delaying the diagnosis
·         NAAT, such as PCR, have been proposed as the solution for a rapid and reliable diagnosis; however there are only a few CE commercial kits with no extensive studies, while literature indicates that home brew PCRs for Mycoplasma pneumoniae may lack of sensitivity and have poor standardization.



The Meridian Bioscience Proposal:

illumigene® Mycoplasma DNA amplification assay (REF. 280550 – 50 tests):
·         The illumigene® Mycoplasma DNA amplification assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection of DNA from Mycoplasma pneumoniae in human throat and nasopharyngeal swabs obtained from patients suspected of having Mycoplasma pneumoniae infection
·         The assay targets a 208 base pair (bp) sequence of the Mycoplasma pneumoniae genome. The target DNA sequence is found in the intracellular protease-like protein gene and is found in all sequences comprising three genomes of Mycoplasma pneumoniae

Product Details:
·         Simple procedure, reagents ready to use
·         Results in about 2 hours (including DNA extraction procedure)
·         Assay & Control Kit  Storage:  2-8° C