Evaluation of the ResistancePlus MG FleXible Assay for Detection of Wild-Type and 23S rRNA-Mutated Mycoplasma genitalium Strains

Drud, Suhella Tulsiani; Njuguna, Peter; Ebeyan, Samantha; Erskine, Simon; Holm, Mette; Johansson, Susanne Cramer; Tan, Lit Yeen; Jensen, Jørgen Skov

doi:10.1128/jcm.01900-19

Cited by 13 publications

(14 citation statements)

References 19 publications

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“…These findings are consistent with a previous report that ResistancePlus MG FleXible has higher analytical sensitivity when testing serial dilutions of samples [7]. Additionally, when compared to extracted DNA tested by MgPa quantitative PCR, the ResistancePlus MG FleXible demonstrated higher sensitivity (86% detection compared to 96% detection, respectively) [8].…”

Section: Discussionsupporting

confidence: 91%

“…Performance was similar across a variety of sample types. There was also strong concordance for mutation detection (97 %), as found in previous reports using stored samples (93-100%) [7,8].…”

Section: Discussionsupporting

confidence: 85%

“…A high degree of concordance with the ResistancePlus MG reference assay was identified for M. genitalium detection (94 %), similar to the sensitivity identified in previous reports that analysed collections of stored samples (96–97%) [7, 8]. Performance was similar across a variety of sample types.…”

Section: Discussionsupporting

confidence: 82%

“…This test reports detection of M. genitalium via detection of the MgPa gene, and MRMs in the 23S rRNA gene (mutations A2058G, A2059G, A2058T, A2058C; Escherichia coli numbering), and has an exogenous internal control. This test has been evaluated for detection limits and evaluated on stored clinical samples [7,8], but has yet to be tested on freshly collected samples. In this study, the ResistancePlus MG FleXible test was validated using freshly collected clinical samples.…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of ResistancePlus MG FleXible, a ‘near-patient’ test for the detection of Mycoplasma genitalium and macrolide resistance mutations, using freshly collected clinical samples

Murray

Doyle

Bodiyabadu

et al. 2021

Journal of Medical Microbiology

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Introduction. Mycoplasma genitalium is a sexually transmitted pathogen with increasing resistance to first- and second-line antimicrobials. The ‘near-patient test’ ResistancePlus MG FleXible (SpeeDx) detects M. genitalium plus four macrolide resistance mutations (MRMs), facilitating same-day patient follow up. Hypothesis/Gap Statement. This assay has not been assessed on freshly collected samples. Aim. Our goal was to evaluate the performance of the ResistancePlus MG FleXible test against the standard of care open platform test. Methods. ResistancePlus MG FleXible (analysed on the Cepheid GeneXpert platform) was evaluated on freshly collected samples and compared to the standard of care open platform test ResistancePlus MG (SpeeDx) analysed on the LightCycler 480 II (Roche). Results. For 270 valid tests, ResistancePlus MG FleXible yielded a high positive per cent agreement (PPA) of 94.1% [96/102; 95 % confidence interval (CI): 87.6–97.8 %] and negative per cent agreement (NPA) of 95.2% (160/168; 95 % CI: 90.8–97.9%) for M. genitalium detection compared to the reference assay (kappa for test concordance of 0.89; 95 % CI: 0.83–0.95). Performance was similar across different sample types. For the detection of MRMs, ResistancePlus MG FleXible had a PPA of 97.1% (66/68; 95% CI: 89.8–99.6) and NPA of 78.6% (22/28; 95 % CI: 59.0–91.7), with test comparison kappa of 0.79 (95 % CI: 0.65–0.93). Notably, of six discordant results (i.e. determined to be wild type by the reference assay), five were positive for MRMs by Sanger sequencing, indicating that the ResistancePlus MG FleXible assay has an improved performance for mutation detection. Conclusion. ResistancePlus MG FleXible had comparable test performance for M. genitalium detection as the open platform assay, with improved detection of MRMs. The ResistancePlus MG FleXible ‘near-patient’ assay can deliver a rapid result to expedite appropriate treatment.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionsupporting

confidence: 85%

Section: Discussionsupporting

confidence: 82%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Evaluation of ResistancePlus MG FleXible, a ‘near-patient’ test for the detection of Mycoplasma genitalium and macrolide resistance mutations, using freshly collected clinical samples

Murray

Doyle

Bodiyabadu

et al. 2021

Journal of Medical Microbiology

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“…An interesting solution is the Resistance Plus MG FleXible (RPMG Flex) assay (SpeeDx). This is a multiplex qPCR test detecting the gene encoding the MgPa adhesion protein and simultaneously detects five 23S rRNA mutations (A2058G, T, or C, and A2059G or C) [ 68 ].…”

Section: Molecular Diagnosticsmentioning

confidence: 99%

The Impact of Selected Bacterial Sexually Transmitted Diseases on Pregnancy and Female Fertility

Smolarczyk

Młynarczyk-Bonikowska

Rudnicka

et al. 2021

IJMS

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Sexually transmitted infections (STIs) caused by Neisseria gonorrhoeae, Chlamydia trachomatis and Mycoplasma genitalium are a common cause of pelvic inflammatory disease (PID) which can lead to tubal factor infertility (TFI). TFI is one of the most common causes of infertility, accounting for 30% of female fertility problems. STIs can also have an impact on pregnancy, leading to adverse pregnancy outcomes. Escalating antibiotic resistance in Neisseria gonorrhoeae and Mycoplasma genitalium represents a significant problem and can be therapeutically challenging. We present a comprehensive review of the current treatment options, as well as the molecular approach to this subject. We have given special attention to molecular epidemiology, molecular diagnostics, current and new treatments, and drug resistance.

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Detection of Human Mycoplasmas and Ureaplasmas from Clinical Specimens by Culture and PCR

Bébéar,

Waites

2023

ClinMicroNow

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Mycoplasma pneumoniae is a common cause of upper and lower respiratory infections in persons of all ages. Tracheobronchitis is the most common clinical syndrome, but pneumonia commonly occurs and extrapulmonary infections have been described. Mycoplasma hominis and Ureaplasma species are recoverable by culture from the human urogenital tract. Mycoplasma genitalium causes male nongonococcal urethritis and has been associated with salpingitis endometritis and cervicitis in women. Susceptibility testing is useful mainly for systemic infections caused by Mycoplasma hominis or Ureaplasma spp. , particularly in immunosuppressed hosts or when treatment failure raises suspicion of acquired resistance, as in the case of macrolide resistance in Mycoplasma pneumoniae . Mycoplasma pneumoniae is a common cause of respiratory tract infections, involved in tracheobronchitis and community‐acquired pneumonia in children and adults.

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Evaluation of the ResistancePlus MG FleXible Assay for Detection of Wild-Type and 23S rRNA-Mutated Mycoplasma genitalium Strains

Cited by 13 publications

References 19 publications

Evaluation of ResistancePlus MG FleXible, a ‘near-patient’ test for the detection of Mycoplasma genitalium and macrolide resistance mutations, using freshly collected clinical samples

Evaluation of ResistancePlus MG FleXible, a ‘near-patient’ test for the detection of Mycoplasma genitalium and macrolide resistance mutations, using freshly collected clinical samples

The Impact of Selected Bacterial Sexually Transmitted Diseases on Pregnancy and Female Fertility

Detection of Human Mycoplasmas and Ureaplasmas from Clinical Specimens by Culture and PCR

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