Clinical Importance of Superior Sensitivity of the Aptima TMA-Based Assays for Mycoplasma genitalium Detection

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Abstract

ABSTRACT

Mycoplasma genitalium (MG) is a common cause of nongonococcal cervicitis and urethritis. We investigated the demographic and clinical characteristics of patients tested in Denmark with the Conformité Européenne (CE)/ in vitro diagnostics (IVD) Aptima Mycoplasma genitalium assay (CE/IVD AMG; Hologic) and examined the clinical significance of the higher sensitivity of the TMA-based MG assays. From March to June 2016, urogenital and extragenital specimens from consecutive attendees at a sexually transmitted infection clinic in Copenhagen, Denmark were tested with the CE/IVD AMG assay (TMA-based), the research-use-only MG Alt TMA-1 assay (Hologic), a laboratory-developed TaqMan mgp B quantitative real-time PCR (qPCR), and the Aptima Combo 2 (CT/NG; Hologic). Demographic characteristics and clinical symptoms were collected from the patient records. There were 1,245 patients included in the study. The MG prevalence among female subjects was 9.4%, and the MG prevalence among male subjects was 8.7%. Compared to the TMA-based assays, the sensitivity of the PCR-based MG assay was 64.52%, and 55 specimens from 48 individuals were missed in the mgp B qPCR. Of these, 26 individuals (54.2%) were symptomatic, whereas, among 64 individuals with concordant results, 30 individuals (46.9%) were symptomatic; no statistically significant difference was found between the groups ( P = 0.567). The improved sensitivity of the TMA-based assays resulted in diagnoses of more patients with clinically relevant symptoms for which antibiotic treatment is indicated. However, approximately half of the MG-infected patients reported no symptoms, and future research is needed to investigate the pros and cons of diagnosing and treating MG in asymptomatic subjects.

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Most cited references 24

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Mycoplasma genitalium: from Chrysalis to multicolored butterfly.

David Taylor-Robinson, J. Groth-Jensen (2011)

The history, replication, genetics, characteristics (both biological and physical), and factors involved in the pathogenesis of Mycoplasma genitalium are presented. The latter factors include adhesion, the influence of hormones, motility, possible toxin production, and immunological responses. The preferred site of colonization, together with current detection procedures, mainly by PCR technology, is discussed. The relationships between M. genitalium and various diseases are highlighted. These diseases include acute and chronic nongonococcal urethritis, balanoposthitis, chronic prostatitis, and acute epididymitis in men and urethritis, bacterial vaginosis, vaginitis, cervicitis, pelvic inflammatory disease, and reproductive disease in women. A causative relationship, or otherwise strong association, between several of these diseases and M. genitalium is apparent, and the extent of this, on a subjective basis, is presented; also provided is a comparison between M. genitalium and two other genital tract-orientated mollicutes, namely, Mycoplasma hominis, the first mycoplasma of human origin to be discovered, and Ureaplasma species. Also discussed is the relationship between M. genitalium and infertility and also arthritis in both men and women, as is infection in homosexual and immunodeficient patients. Decreased immunity, as in HIV infections, may enhance mycoplasmal detection and increase disease severity. Finally, aspects of the antimicrobial susceptibility and resistance of M. genitalium, together with the treatment and possible prevention of mycoplasmal disease, are discussed.

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Use of TaqMan 5' nuclease real-time PCR for quantitative detection of Mycoplasma genitalium DNA in males with and without urethritis who were attendees at a sexually transmitted disease clinic.

Jørgen Jensen, Eva Björnelius, Birthe Dohn … (2004)

Mycoplasma genitalium is a cause of nongonococcal urethritis, particularly in patients not infected with Chlamydia trachomatis. A quantitative 5' nuclease assay (TaqMan PCR) was developed and validated. The assay detected a fragment of the MgPa adhesin gene by use of a TaqMan MGB (minor groove binder) probe and included an internal processing control to detect PCR inhibition. Urethral swab specimens and first-void urine samples from M. genitalium-positive men were examined, and the M. genitalium DNA load was correlated to symptoms and signs. The assay consistently detected <5 genome copies without cross-reactions with other mycoplasmas. Urine and urethral swab specimens from men with urethritis had higher M. genitalium DNA loads than specimens from men without urethritis. However, a very broad overlap of DNA loads between patients with and without urethritis was observed. Urethral swab specimens from patients with urethral discharge had a significantly higher DNA load than specimens from patients without discharge. This correlation was not found in first-void urine specimens.

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Mycoplasma genitalium infection and female reproductive tract disease: a meta-analysis.

Rebecca Lis, Ali Rowhani-Rahbar, Lisa E. Manhart (2015)

To determine the association between Mycoplasma genitalium infection and female reproductive tract syndromes through meta-analysis, English-language, peer-reviewed studies were identified via PubMed, Embase, Biosis, Cochrane Library, and reference review. Two reviewers independently extracted data. Random-effects models were employed to calculate summary estimates, between-study heterogeneity was evaluated using I(2) statistics, publication bias was assessed via funnel plots and the Begg and Egger tests, and methodologic quality was rated. Mycoplasma genitalium infection was significantly associated with increased risk of cervicitis (pooled odds ratio [OR], 1.66 [95% confidence interval {CI}, 1.35-2.04]), pelvic inflammatory disease (pooled OR, 2.14 [95% CI, 1.31-3.49]), preterm birth (pooled OR, 1.89 [95% CI, 1.25-2.85]), and spontaneous abortion (pooled OR, 1.82 [95% CI, 1.10-3.03]). Risk of infertility was similarly elevated (pooled OR, 2.43 [95% CI, .93-6.34]). In subanalyses accounting for coinfections, all associations were stronger and statistically significant. Testing of high-risk symptomatic women for M. genitalium may be warranted.

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Author and article information

Contributors

Kirsten Salado-Rasmussen: (View ORCID Profile)

Jørgen Skov Jensen: (View ORCID Profile)

Journal

Title: Journal of Clinical Microbiology

Abbreviated Title: J Clin Microbiol

Publisher: American Society for Microbiology

ISSN (Print): 0095-1137

ISSN (Electronic): 1098-660X

Publication date Created: April 20 2022

Publication date (Print): April 20 2022

Volume: 60

Issue: 4

Affiliations

[1 ]Department of Dermato-Venereology, Bispebjerg Hospital, Copenhagen University Hospital, Copenhagen, Denmark

[2 ]Infection Preparedness, Research Unit for Reproductive Tract Microbiology, Statens Serum Institut, Copenhagen, Denmark

[3 ]World Health Organization Collaborating Centre for Gonorrhoea and Other STIs, Department of Laboratory Medicine, Microbiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden