Performance of the ResistancePlus MG diagnostic test for Mycoplasma genitalium using samples collected with Hologic Aptima Specimen Collection kits

Gerald L. Murray; Jennifer Danielewski; Catriona S. Bradshaw; Deborah A. Williamson; Joshua Birnie; Jenny P. Su; Vesna De Petra; Lit Y. Tan; Rachel Wee; Dorothy A. Machalek; Tim R. H. Read; Suzanne M. Garland

doi:10.1099/jmm.0.001140

Volume 69, Issue 2

Short Communication

Free

Performance of the ResistancePlus MG diagnostic test for Mycoplasma genitalium using samples collected with Hologic Aptima Specimen Collection kits

Gerald L. Murray^1,2,3,4, Jennifer Danielewski^2,3, Catriona S. Bradshaw^5,6, Deborah A. Williamson^4,7, Joshua Birnie³, Jenny P. Su³, Vesna De Petra⁴, Lit Y. Tan⁸, Rachel Wee⁸, Dorothy A. Machalek^2,3,9, Tim R. H. Read^5,6 and Suzanne M. Garland^1,2,3
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Affiliations: ¹ The Department of Obstetrics and Gynaecology, The University of Melbourne, Parkville, VIC 3052, Australia ² Centre for Women’s Infectious Diseases, The Royal Women’s Hospital, Parkville, VIC 3052, Australia ³ Molecular Microbiology Research Group, Murdoch Children’s Research Institute, Parkville, VIC 3052, Australia ⁴ The Microbiological Diagnostic Unit Public Health Laboratory, The University of Melbourne, The Peter Doherty Institute for Infection and Immunity, Melbourne, VIC 3000, Australia ⁵ Melbourne Sexual Health Centre, Alfred Health, Carlton, VIC 3053, Australia ⁶ Central Clinical School, Monash University, Melbourne, VIC 3004, Australia ⁷ Doherty Applied Microbial Genomics, Department of Microbiology and Immunology, The University of Melbourne, Melbourne, VIC 3000, Australia ⁸ SpeeDx Pty Ltd, Sydney, Australia ⁹ Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Parkville, VIC, 3052, Australia
*Correspondence: Gerald L. Murray, [email protected]
Published: 20 January 2020 https://doi.org/10.1099/jmm.0.001140

Abstract

Introduction. Mycoplasma genitalium is a sexually transmitted organism with high levels of resistance to the recommended first-line therapy, azithromycin. The ResistancePlus MG test concurrently detects M. genitalium, and the presence of macrolide-resistance mutations (MRM). European, UK and Australian guidelines recommend a diagnostic test that reports MRM to optimize treatment through resistance-guided therapy. Hence, for samples collected for use on other platforms, reflex testing using the ResistancePlus MG test would be beneficial.

Aim. To validate the ResistancePlus MG assay using samples collected in Aptima buffer for testing on the Hologic Panther.

Methodology. Positive (n=99) and negative (n=229) clinical samples collected in Aptima buffer were extracted on the MagNA Pure 96 (Roche Diagnostics), and tested with the ResistancePlus MG test on the LightCycler 480 II (Roche Diagnostics). Results were compared to matched samples collected using standard sample collection (urine or swab resuspended in PBS), with positive percent agreement (PPA), negative percent agreement (NPA) and Cohen’s Kappa statistic.

Results. The ResistancePlus MG test had high performance with a 200 µl input volume (PPA/NPA for M. genitalium detection, 92.9 % [95 % confidence interval (CI): 85.5–96.9]/100 % [95 % CI: 97.9–100], MRM detection, 96.9 % [95 % CI: 88.2–99.5]/85.7 % [95 % CI: 66.4–95.3]) and for 1 ml input volume (PPA/NPA for M. genitalium detection, 95.9%/96.6%, MRM detection, 98.4%/90.3%). Samples remained positive after storage at room temperature beyond the manufacturer-recommended storage of <60 days (mean storage time for 1 ml extraction: 129 days).

Conclusion. Samples collected using Aptima collection kits are suitable for reflex testing using the ResistancePlus MG test, allowing detection of macrolide resistance.

Received: 20/08/2019
Accepted: 19/12/2019
Published Online: 20/01/2020

Keyword(s): antibiotic resistance , Aptima , diagnostic test , Mycoplasma genitalium and quantitative PCR

Funding

This study was supported by the:

Department of Health, State Government of Victoria
- Principle Award Recipient: Gerald Murray
Department of Industry and Science, Australian Government (Award ICG000220)
- Principle Award Recipient: Gerald Murray
National Health and Medical Research Council (Award GNT1123854)
- Principle Award Recipient: Deborah A. Williamson
National Health and Medical Research Council (Award 1091536)
- Principle Award Recipient: Tim R. H. Read

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Performance of the ResistancePlus MG diagnostic test for Mycoplasma genitalium using samples collected with Hologic Aptima Specimen Collection kits

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Volume 69, Issue 2

Short Communication

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Performance of the ResistancePlus MG diagnostic test for Mycoplasma genitalium using samples collected with Hologic Aptima Specimen Collection kits

Abstract

Funding

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