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Diagnostic Methods

Clinical reference laboratories are able to provide diagnostic testing for Mycoplasma pneumoniae (M. pneumoniae) infections with culture, serology, or molecular methods (refer to the chart below). Currently, there are two commercially available molecular kits (FDA approved) for the detection of M. pneumoniae infection. When additional or specialized testing is necessary local or state public health laboratories may be able to either provide diagnostic support or forward specimens to the CDC.

Better M. pneumoniae diagnostic tests are needed, including the development of a rapid, reliable and cost-effective means to detect the pathogen at the point of care. Expertise and capacity to perform diagnostics is also more widely needed at state and local public health laboratories.

Advantages, Disadvantages and the Availability of Select M. pneumoniae Diagnostic Methods

MethodAdvantagesDisadvantagesTest Setting
Culture
  • Provides clinical isolates for genotyping and antimicrobial susceptibilities testing
  • 100% specificity when a positive result is obtained1
  • Commercially available SP4 media
  • Time-consuming
  • Requires specialized expertise
  • High potential for false negatives
  • Slow growth
  • Reference laboratories only; not for routine diagnostics
Serology
  • Commercially available kits
  • Quantitation possible
  • Lacks specificity
  • Need for acute and convalescent paired sera
  • Test results turn-around time not optimal for treatment decisions
  • Cumbersome and time-sensitive sampling
  • Not FDA approved
  • Clinical services: Sera provided to a clinical laboratory testing service for EIA testing4
Molecular
  • Commercially available kits
  • High sensitivity and specificity
  • Rapid detection
  • Results can be obtained in time to guide treatment decisions
  • Useful for strain typing
  • Expensive
  • Requires specialized expertise and equipment
  • Not standardized
  • Lack of clinical and comparative validation
  • Limited FDA approval
  • Clinical services: NP, OP, or sputum provided to a clinical laboratory testing service for qPCR testing4
  • CDC: Multiplex qPCR used for M. pneumoniae detection in NP, OP, sputum, tissue, or CSF2,3
  • Commercial/FDA approved: FilmArray (BioFire, Inc.) is a nested multiplex PCR in a closed “lab-in-a-pouch” format
    Illumigene (Meridian Biosciences, Inc.) is a loop-mediated Isothermal amplification (LAMP) assay

1 Provided that appropriate additional procedures are used to identify the organism isolated to species level.

2 Various quality control measures in place for this assay including compliance with Clinical Laboratory Improvement Amendments standards and the use of proficiency testing through Quality Control for Molecular Diagnostics.

3 Other testing performed by the CDC only for special investigations include: using specialized SP4 media used for isolation and isolate typing, serology as a supportive measure, and molecular typing procedures such as macrolide susceptibility testing, P1 adhesion typing, and MLVA typing.

4 State and local departments of public health may offer these diagnostic tests for the detection of M. pneumoniae.


SP4—modified Spiroplasma medium, EIA - enzyme immunoassay, qPCR—quantitative polymerase chain reaction, MLVA—multiple-locus variable number tandem repeat analysis, NP—nasopharyngeal, OP—oropharyngeal, CSF—cerebrospinal fluid


References

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