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Evaluation of 5 commercial assays for the detection of Mycoplasma genitalium and other Urogenital Mycoplasmas

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Abstract

The focus on urogenital mycoplasmas as the possible etiologic agents of urogenital infections and syndromes, has increased in the last decade. Of these, Mycoplasma genitalium is proven to be pathogenic and sexually transmitted. We compared five commercially available assays for the detection of these organisms in urogenital mycoplasma culture specimen remnants. Stored specimen remnants were tested on Aptima Mycoplasma genitalium, Allplex™ STI Essential and CGMT, ResitancePlus®MG and Allplex™ MG & AziR Assays. All positive M. genitalium specimens and culture negative, nucleic acid positive Ureaplasmas were sent to the National Microbiology Laboratory for confirmation. The Aptima Mycoplasma genitalium assay detected 7 M. genitalium infections, the Allplex™ STI-EA and the Allplex™ CGMT detected 6 M. genitalium positives, and the Allplex™MG and AziR and SpeeDx ResistancePlus® MG detected 5 M. genitalium positives, four with macrolide resistant genes. The Allplex™ STI Essential assay was 100% sensitive and specific for Mycoplasma hominis and Ureaplasma targets. As seen in other studies, the Aptima Mycoplasma genitalium assay was 100% sensitive and specific for the detection of M. genitalium. The multiplex assays had lower sensitivities for M. genitalium detection (Allplex™ STI Essential and CGMT sensitivity of 85.71%; Allplex™ MG & AziR and SpeeDx ResistancePlus® MG sensitivity of 71.43%) with high specificities of 100%. Assays tested have high sensitivities and specificities for the detection of urogenital mycoplasmas especially M. genitalium macrolide resistance markers. All labs wanting to perform onsite detection of these organisms will find an assay to easily fit into their workflow.

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Funding

This project had no external funding. The labor was provided in kind by the laboratories and test kits were provided by the manufacturers at no charge. Seegene Inc. provided the CFX96 as a loan for the duration of the study.

Author information

Authors and Affiliations

  1. Provincial Laboratory for Public Health (ProvLab), Alberta Precision Laboratories, Edmonton, Alberta, Canada

    Prenilla Naidu, Sandy Shokoples & Nathan Zelyas

  2. Department of Medical Microbiology and Immunology, University of Alberta, 2B3.13 Walter Mackenzie Health Sciences Centre, University of Alberta Hospital, 8440 112 Street, Edmonton, AB, T6G 2J2, Canada

    Prenilla Naidu

  3. National Microbiology Laboratory, Winnipeg, Canada

    Irene Martin

  4. Department of Laboratory Medicine and Pathology, University of Alberta, Edmonton, Alberta, Canada

    Nathan Zelyas

  5. Department of Medicine, University of Alberta, Edmonton, Alberta, Canada

    Ameeta Singh

Authors
  1. Prenilla Naidu
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  2. Sandy Shokoples
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  3. Irene Martin
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  4. Nathan Zelyas
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  5. Ameeta Singh
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Contributions

PN conceived the study, developed the study methodology with NZ and SS, reviewed the study results and authored the manuscript together with AS. SS performed all the testing and collated the results. Irene Martin performed the confirmatory testing. All authors participated in the review and editing of the manuscript.

Corresponding author

Correspondence to Prenilla Naidu.

Ethics declarations

Conflict of interest

Prenilla Naidu received honoraria for speaking engagements from Hologic® (2016) and Seegene Inc. (2019). The other authors have no conflicts of interest to declare.

Ethical approval

Ethics approval for the study was obtained from the Human Research Ethics Board at the University of Alberta. The authors confirm that this manuscript reports on results of their original research. This manuscript is not under consideration for publication by any other journal. A small portion of the data (the Seegene assay results) was presented at a workshop at the STI & HIV 2019 World Congress in Vancouver, Canada.

Consent to participate

Remnant specimens submitted for testing of the same organisms by culture were anonymized and used for this study. Consent to participate in this study was thus not required.

Consent for publication

All authors have approved this manuscript for submission for publication.

Additional information

Edited by Volkhard A. J. Kempf.

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Naidu, P., Shokoples, S., Martin, I. et al. Evaluation of 5 commercial assays for the detection of Mycoplasma genitalium and other Urogenital Mycoplasmas. Med Microbiol Immunol 210, 73–80 (2021). https://doi.org/10.1007/s00430-021-00699-1

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  • DOI: https://doi.org/10.1007/s00430-021-00699-1

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