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

Publikation: Bidrag til tidsskriftTidsskriftartikelfagfællebedømt

  • Kirsten Salado-Rasmussen
  • Jacob Tolstrup
  • Farnam Barati Sedeh
  • thg519, thg519
  • Magnus Unemo
  • Jørgen Skov Jensen

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 mgpB 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 mgpB 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.

TidsskriftJournal of clinical microbiology
Udgave nummer4
Sider (fra-til)1-8
StatusUdgivet - 2022

Bibliografisk note

Funding Information:
We thank Britt Nilausen and the nursing staff at the Department of Dermato-Venereology, Bispebjerg Hospital, Copenhagen University Hospital, for the great effort during the collection of specimens. Henrik Westh, Department of Clinical Microbiology, Hvidovre Hospital, Copenhagen University Hospital, is thanked for analyzing the specimens with the CE/IVD AMG assay, the research-use-only MG Alt TMA-1 assay (Hologic), and the Aptima Combo 2 (CT/NG).

Publisher Copyright:
Copyright © 2022 American Society for Microbiology. All Rights Reserved.

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