A comparison of molecular assays for Mycoplasma pneumoniae in pediatric patients

Chou, Raymond; Zheng, Xiaotian

doi:10.1016/j.diagmicrobio.2015.12.013

Cited by 5 publications

(5 citation statements)

References 15 publications

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“…30 The performance characteristics for PCR assays for M pneumoniae seem to be at least as good as those for Legionella infections and possibly better. 31,32 As with other pathogens, the detection rate of M pneumoniae using PCR on nasopharyngeal aspirates is lower than in sputum samples. 28 Recently, there has been interest in antigen detection assays for the diagnosis of M pneumoniae because these offer the potential for point-of-care testing, but so far these have yet to enter the clinical mainstream.…”

Section: Mycoplasmamentioning

confidence: 99%

Diagnosing Viral and Atypical Pathogens in the Setting of Community-Acquired Pneumonia

Waterer

2017

Clinics in Chest Medicine

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The 'atypical' pathogens causing pneumonia have long been problematic for physicians because we have had to rely on serologic tests to make a diagnosis. The introduction of polymerase chain reaction techniques revolutionized the diagnosis of respiratory infections and now a new wave of technologies promising faster, cheaper, and more comprehensive testing are becoming available. This review focuses principally on the diagnosis of Legionella, Mycoplasma, and influenza infections, but also covers recent publications on the cutting edge of diagnostic tools likely to transform the field of infectious diseases over the coming decade.

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Section: Mycoplasmamentioning

confidence: 99%

Diagnosing Viral and Atypical Pathogens in the Setting of Community-Acquired Pneumonia

Waterer

2017

Clinics in Chest Medicine

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“…In our previous evaluation of the illumigene Mycoplasma DNA amplification assay, the forerunner of Mycoplasma Direct (26), among 214 respiratory specimens from a variety of sources previously cultured for M. pneumoniae (indicative of a higher organism load), the sensitivity of the illumigene assay was 100% and the specificity was 99%. Chou and Zheng identified the sensitivity and specificity of the illumigene assay to be 100% compared with those of the FilmArray RP and also reported a greater analytic sensitivity for the illumigene (23.5 CFU/ml versus 235 CFU/ml for the FilmArray RP) (22). The Mycoplasma Direct assay does not require a separate DNA extraction step, making it similar in this respect to the multiplex systems.…”

Section: Discussionmentioning

confidence: 99%

“…Since molecular testing has become more widely available in recent years and there are now several FDA-cleared assays, this diagnostic approach can now be considered the method of choice (3). Some molecularly based assays require separate DNA extraction, while others perform extraction, amplification, and detection on specimens inoculated directly into the instruments with results available in about 1 to 4 h. Although there are several previous publications describing the performance of various commercial molecularly based assays that include statistics on their ability to detect M. pneumoniae, most studies involving multiplex platforms have focused primarily on detection of respiratory viruses and included a relatively small number of specimens testing positive for M. pneumoniae (10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26). No previous studies have evaluated large numbers of M. pneumoniae-positive specimens to enable thorough head-to-head comparisons of commercial molecular diagnostic platforms available in the United States.…”

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confidence: 99%

Evaluation of Commercial Molecular Diagnostic Methods for Detection and Determination of Macrolide Resistance in Mycoplasma pneumoniae

et al. 2020

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We evaluated six commercial molecular tests targeting Mycoplasma pneumoniae, namely, the BioFire FilmArray respiratory panel (RP), the Meridian Alethia Mycoplasma Direct, the GenMark ePlex respiratory pathogen panel (RPP), the Luminex NxTAG RPP, the ELITech ELITe InGenius Mycoplasma MGB research use only (RUO) PCR, and the SpeeDx Resistance Plus MP assays. Laboratory-developed PCR assays at the University of Alabama at Birmingham and the Centers for Disease Control and Prevention were used as reference standards. Among 428 specimens, 212 were designated confirmed positives for M. pneumoniae. The highest clinical sensitivities were found with the InGenius PCR (99.5%) and the FilmArray RP (98.1%). The Resistance Plus MP identified 93.3% of the confirmed-positive specimens, whereas 83.6, 64.6, and 55.7% were identified by the ePlex RPP, NxTAG RPP, and Mycoplasma Direct assays, respectively. There was no significant difference between the sensitivity of the reference methods and that of the FilmArray RP and InGenius assays, but the remaining four assays detected significantly fewer positive specimens (P < 0.05). Specificities of all assays were 99.5 to 100%. The Resistance Plus MP assay detected macrolide resistance in 27/33 specimens, resulting in a sensitivity of 81.8%. This study provides the first large-scale comparison of commercial molecular assays for detection of M. pneumoniae in the United States and identified clear differences among their performance. Additional studies are necessary to explore the impact of various test performances on patient outcome.

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“…A previous study ( 8 ) in the United States compared the iM assay, the Prodesse ProPneumo-1 assay (Hologic Gen-Probe, San Diego, CA, USA), and the Mycoplasma pneumoniae P1 LightMix kit (TIB Molbiol, Howell, NJ, USA) with the FilmArray respiratory panel (bioMérieux, France) for detection of M. pneumoniae from pediatric clinical nasopharyngeal swab specimens. All of the three commercially available NAAT assays had similar sensitivities, specificities (100%, 100%, and 96% for the iM assay, the Prodesse assay, and the LightMix kit, respectively), and hands-on times.…”

Section: Discussionmentioning

confidence: 99%

“…A study found the sensitivity and specificity of the iM assay to be 100% and 99%, respectively, compared with the culture method ( 1 ). Another recent study found both sensitivity and specificity of the iM assay to be 100%, compared with the FilmArray respiratory panel (bioMérieux, France) ( 8 ).…”

Section: Introductionmentioning

confidence: 99%

Evaluation of the illumigene Mycoplasma Direct DNA Amplification Assay

et al. 2018

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Mycoplasma pneumoniae is a common cause of community-acquired pneumonia. The illumigene Mycoplasma Direct (iMD) DNA amplification assay is a qualitative in vitro test utilizing loop-mediated isothermal amplification (LAMP) technology for the direct detection of M. pneumoniae DNA in respiratory specimens. The iMD assay does not require the preextraction of nucleic acids from specimens, which is a prerequisite step for the previously approved illumigene Mycoplasma (iM) assay. The aim of this prospective multicenter study was to evaluate the performance characteristics of the newly developed iMD assay, compared with the iM assay. Subjects with symptoms of upper respiratory illnesses suggesting M. pneumoniae infection were enrolled at three sites in the United States. Respiratory specimens were obtained using dual throat swabs. One swab was tested with the iMD assay at each enrollment site. Reference testing with the iM assay was performed by the manufacturer. Among 456 specimens tested, the iM reference method detected M. pneumoniae in 25 specimens (5.5%), while the iMD assay identified 34 specimens (7.5%) as M. pneumoniae positive. There were 10 false-positive results and 1 false-negative result with the iMD assay. The overall positive and negative agreement rates were 96.0% (95% confidence interval [CI], 80.5 to 99.3%) and 97.7% (95% CI, 95.8 to 98.7%), respectively. The overall agreement rate was determined to be 97.6% (95% CI, 95.7 to 98.6%). We conclude that the iMD test results were comparable to the iM assay results. The removal of the DNA extraction step for the iMD assay simplifies testing, saves time, and reduces the costs of detecting M. pneumoniae from throat swabs, compared to the iM assay.

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A comparison of molecular assays for Mycoplasma pneumoniae in pediatric patients

Cited by 5 publications

References 15 publications

Diagnosing Viral and Atypical Pathogens in the Setting of Community-Acquired Pneumonia

Diagnosing Viral and Atypical Pathogens in the Setting of Community-Acquired Pneumonia

Evaluation of Commercial Molecular Diagnostic Methods for Detection and Determination of Macrolide Resistance in Mycoplasma pneumoniae

Evaluation of the illumigene Mycoplasma Direct DNA Amplification Assay

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