Aptima Mycoplasma Genitalium Assay Research Articles

Prevalence and incidence of Mycoplasma genitalium infection: a systematic review protocol.

The objective of this review is to determine the prevalence and incidence of Mycoplasma genitalium infection. Mycoplasma genitalium is a sexually transmitted pathogen that can cause reproductive health issues in men and women. Recent US Food and Drug Administration (FDA)-approved testing has improved the capability to more readily diagnose and treat this infection. Determining the incidence and prevalence of this sexually transmitted infection is imperative to better understand the epidemiologic implications and long-term consequences of this disease process. Studies involving males and females of any age, race, or cultural background will be eligible. Studies conducted in any setting or geographical location that report on prevalence or incidence of Mycoplasma genitalium infection diagnosed by the FDA-approved Aptima Mycoplasma genitalium assay will be included. The proposed systematic review will be conducted in accordance with JBI methodology for systematic reviews of prevalence and incidence, and in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. MEDLINE (PubMed), CINAHL (EBSCOhost), Embase, Web of Science, and Global Infectious Diseases and Epidemiology Network (GIDEON) databases will be searched, with no date limits. Prevalence and incidence data, experimental, quasi-experimental, observational, and descriptive studies will be included, and critically appraised by 2 independent reviewers. Data will be extracted using standardized JBI data extraction tools. If sufficient data are available, a meta-analysis will be conducted; otherwise, the findings will be presented in narrative format, including tables and figures to aid in data presentation, where appropriate. PROSPERO CRD42023415457.

Evaluating specimen pooling for Neisseria gonorrhoeae, Chlamydia trachomatis, and Mycoplasma genitalium screening in asymptomatic men who have sex with men.

Screening for Neisseria gonorrhoeae and Chlamydia trachomatis is recommended for individuals at high-risk for sexually transmitted infections (STIs), while the role of Mycoplasma genitalium screening is still unclear. We evaluated whether specimen pooling is an effective alternative for sexually transmitted infection testing during resource shortages. This 2-year prospective study enrolled 135 asymptomatic patients from a community outreach site who identified as men who have sex with men. Oropharyngeal, urine, and/or rectal swab specimens were pooled and tested using the Aptima Combo 2 assay for Neisseria gonorrhoeae and Chlamydia trachomatis. The Aptima Mycoplasma genitalium assay was performed on 34 patients whose specimens had sufficient sample volume for additional testing. Results from pooled specimens were compared to results obtained by individual-site testing. The positive percent agreement (PPA) between pooled testing and individual-site testing was 93.8% and negative percent agreement (NPA) was 100% for Neisseria gonorrhoeae. For Chlamydia trachomatis, the PPA was 85.7% and NPA was 99.2%. A PPA of 72.7% and NPA of 95.7% were observed for Mycoplasma genitalium. Discrepancy analysis revealed the majority of false-negative pools were from failure to detect positive rectal samples. Specimen pooling reduces sensitivity of the Aptima assays for Chlamydia trachomatis, Neisseria gonorrhoeae, and Mycoplasma genitalium and thus should be used with caution.

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

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.

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

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 6M. genitalium positives, and the Allplex™MG and AziR and SpeeDx ResistancePlus® MG detected 5M. 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.

Mycoplasma genitalium Infection in Young Women Without Urogenital Symptoms Presenting to a Community-Based Emergency Department in Birmingham, Alabama.

We used the Food and Drug Administration-cleared Aptima Mycoplasma genitalium assay to evaluate for M. genitalium infection among young women without urogenital symptoms presenting to a community-based emergency department in Birmingham, Alabama, between August 2016 to August 2019 for evaluation of nongynecological concerns. M. genitalium was detected in 23 (14.8%) of 155 women.

Sensitivity of a transcription-mediated amplification method (Aptima Mycoplasma genitalium assay) to detect M. genitalium in vitro

IntroductionMycoplasma genitalium is a known causative pathogen for some sexually transmitted infections. Nucleic acid amplification tests are a recommended method for detecting M. genitalium. A transcription-mediated amplification (TMA) nucleic acid amplification test to detect M. genitalium, the Aptima Mycoplasma genitalium assay was approved by the Food and Drug Administration in the United States and has been used in other countries. The purpose of this study is to determine the sensitivity of TMA test as the detection limit for 20 strains. MethodThe sensitivity of the TMA test was re-examined using 20 strains in vitro and the detection limit was estimated by comparison with the MgPa quantitative real-time PCR (qPCR) method. The M. genitalium strains used were isolated from Denmark, Norway, Sweden, France and Japan, and included macrolide or fluoroquinolone resistance. Stock strains were used at several dilutions, with each dilution of each strain examined using both TMA test and qPCR methods. Result and conclusionEstimated DNA loads of M. genitalium as the detection limit were 0.03–0.87 genome equivalents/mL. Sensitivity for TMA test was almost 100-fold higher than for the qPCR method.

A profile of the FDA-approved and CE/IVD-marked Aptima Mycoplasma genitalium assay (Hologic) and key priorities in the management of M. genitalium infections

ABSTRACT Introduction Mycoplasma genitalium (MG) causes frequently asymptomatic STIs. MG prevalence figures are lacking and management is complicated by the lack of etiological diagnostics and high antimicrobial resistance in many countries. Appropriately validated, quality-assured, and FDA-approved MG diagnostic assays have been lacking. Areas covered The clinical and analytical performance characteristics of the Aptima® MG assay, the first FDA-approved MG nucleic acid amplification test (NAAT), are summarized. Key priorities in the management and control of MG infections are also discussed. Expert opinion Highly sensitive, specific, and quality-assured MG NAATs, e.g. the Aptima MG assay on the automated and flexible Panther® platform, are imperative to improve the management and control of MG infections internationally. This testing, combined with macrolide-resistance testing (not yet available on the Panther platform), offers a rapid, high-throughput, and appropriate diagnosis of MG. Macrolide resistance-guided sequential treatment needs to be implemented for MG infections. Dual antimicrobial therapy, novel antimicrobials and, ideally, a vaccine may become essential.

Extragenital Mycoplasma genitalium infections among men who have sex with men

ObjectivesThere are limited data on the prevalence of Mycoplasma genitalium (Mgen) coinfection with rectal chlamydia (Chlamydia trachomatis (CT)) and rectal gonorrhoea (Neisseria gonorrhoeae (NG)) infections and few studies examining the...

Barriers to testing and management of Mycoplasma genitalium infections in primary care.

Testing and treatment for Mycoplasma genitalium (MG) infections has recently been facilitated by the increasing availability of molecular tests, but the role of testing in community-based populations is not established. Between 15 May 2017 and 22 November 2017, we tested 561 samples from 547 individuals presenting to primary care in Auckland, New Zealand, requesting investigation for sexually transmitted infections, with concurrent sterile pyuria, using the Aptima MG assay (Hologic, San Diego, CA, USA) in order to establish the prevalence of MG in this group, rates of macrolide resistance and audit primary care’s capacity to manage infections in line with international guidelines. MG was detected in 55 (10%) samples, and co-pathogens were detected in 24 (44%) MG-positive samples. Macrolide resistance mutations were detected in 22/36 (61%) samples subsequently tested using PlexPCR M. genitalium ResistancePlus (Speedx Pvt Ltd., Sydney, Australia). Empiric azithromycin treatment was given to 18 (33%) patients, and test of cure was performed in 15 (27%) patients. Our pilot study demonstrates that sterile pyuria can be a useful marker to direct testing resources in community settings, but highlights important barriers to management of MG in primary care, including clinician knowledge, high prevalence of macrolide resistance and poor completion rates for test of cure.

Clinical and analytical evaluation of the new Aptima Mycoplasma genitalium assay, with data on M. genitalium prevalence and antimicrobial resistance in M. genitalium in Denmark, Norway and Sweden in 2016

ObjectivesMycoplasma genitalium (MG) causes urethritis and cervicitis, potentially causing reproductive complications. Resistance in MG to first-line (azithromycin) and second-line (moxifloxacin) treatment has increased. We examined the clinical and analytical performance of the new Conformité Européene (CE)/in vitro diagnostics (IVD) Aptima Mycoplasma genitalium assay (CE/IVD AMG; Hologic); the prevalence of MG, Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG); and MG resistance to azithromycin and moxifloxacin in Denmark, Norway and Sweden in 2016. MethodsFrom February 2016 to February 2017, urogenital and extragenital (only in Denmark) specimens from consecutive attendees at three sexually transmitted disease clinics were tested with the CE/IVD AMG, the research-use-only MG Alt TMA-1 assay (Hologic), Aptima Combo 2 (CT/NG) assay and a laboratory-developed TaqMan real-time mgpB quantitative real-time PCR (qPCR). Resistance-associated mutations were determined by sequencing. Strains of MG and other mycoplasma species in different concentrations were also tested. ResultsIn total 5269 patients were included. The prevalence of MG was 7.2% (382/5269; 4.9–9.8% in the countries). The sensitivity of the CE/IVD AMG, MG Alt TMA-1 and mgpB qPCR ranged 99.13–100%, 99.13–100% and 73.24–81.60%, respectively, in the countries. The specificity ranged 99.57–99.96%, 100% and 99.69–100%, respectively. The prevalence of resistance-associated mutations for azithromycin and moxifloxacin was 41.4% (120/290; 17.7–56.6%) and 6.6% (18/274; 4.1–10.2%), respectively. Multidrug resistance was found in all countries (2.7%; 1.1–4.2%). ConclusionsBoth transcription-mediated amplification (TMA)-based MG assays had a highly superior sensitivity compared to the mgpB qPCR. The prevalence of MG and azithromycin resistance was high. Validated and quality-assured molecular tests for MG, routine resistance testing of MG-positive samples and antimicrobial resistance surveillance are crucial.