New Aptima Mycoplasma genitalium Assay Evaluated
By LabMedica International staff writers Posted on 12 Oct 2017 |
Image: The Aptima Mycoplasma genitalium Assay (Photo courtesy of Hologic).
Mycoplasma genitalium (MG) frequently causes non-gonococcal urethritis (NGU) in males, and is associated with cervicitis, pelvic inflammatory disease, endometritis and probably infertility.
Nucleic acid amplification tests (NAATs) are the only appropriate diagnostic methods. Many commercially available and particularly laboratory-developed diagnostic polymerase chain reactions (PCRs) have been used.
A large team of scientists working with those at Örebro University (Örebro, Sweden) collected urogenital and extra-genital (only in Denmark) specimens from consecutive attendees at three STD clinics from February 2016 to February 2017. The specimens were tested with the CE/IVD AMG, the research-use-only MG Alt TMA-1 assay, Aptima Combo 2 Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) (CT/NG) assay, and a laboratory-developed TaqMan real-time mgpB qPCR. Resistance-associated mutations were determined by sequencing. Strains of MG and other mycoplasma species in different concentrations were also tested. The CE/IVD AMG the Aptima Combo 2 (CT/NG) assays was performed on Hologic’s Panther system.
In total 5,269 patients were included in the study. The prevalence of MG was 7.2% (382/5269; 4.9%-9.8% in the different countries). The sensitivity of the CE/IVD AMG, MG Alt TMA-1 and mgpB qPCR ranged between 99.13%-100%, 99.13%-100%, and 73.24%-81.60%, respectively, in the countries. The specificity ranged between 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%).
The authors concluded that the new CE/IVD Aptima Mycoplasma genitalium assay (Hologic) performed in the fully automated Panther system showed a high clinical sensitivity and specificity and offers a simple, rapid, sensitive and specific MG diagnostics, which can be easily combined with detection of CT, NG and Trichomonas vaginalis. The study was published on September 17, 2017, in the journal Clinical Microbiology and Infection.
Related Links:
Örebro University
Nucleic acid amplification tests (NAATs) are the only appropriate diagnostic methods. Many commercially available and particularly laboratory-developed diagnostic polymerase chain reactions (PCRs) have been used.
A large team of scientists working with those at Örebro University (Örebro, Sweden) collected urogenital and extra-genital (only in Denmark) specimens from consecutive attendees at three STD clinics from February 2016 to February 2017. The specimens were tested with the CE/IVD AMG, the research-use-only MG Alt TMA-1 assay, Aptima Combo 2 Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) (CT/NG) assay, and a laboratory-developed TaqMan real-time mgpB qPCR. Resistance-associated mutations were determined by sequencing. Strains of MG and other mycoplasma species in different concentrations were also tested. The CE/IVD AMG the Aptima Combo 2 (CT/NG) assays was performed on Hologic’s Panther system.
In total 5,269 patients were included in the study. The prevalence of MG was 7.2% (382/5269; 4.9%-9.8% in the different countries). The sensitivity of the CE/IVD AMG, MG Alt TMA-1 and mgpB qPCR ranged between 99.13%-100%, 99.13%-100%, and 73.24%-81.60%, respectively, in the countries. The specificity ranged between 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%).
The authors concluded that the new CE/IVD Aptima Mycoplasma genitalium assay (Hologic) performed in the fully automated Panther system showed a high clinical sensitivity and specificity and offers a simple, rapid, sensitive and specific MG diagnostics, which can be easily combined with detection of CT, NG and Trichomonas vaginalis. The study was published on September 17, 2017, in the journal Clinical Microbiology and Infection.
Related Links:
Örebro University
Latest Microbiology News
- Enhanced Rapid Syndromic Molecular Diagnostic Solution Detects Broad Range of Infectious Diseases
- Clinical Decision Support Software a Game-Changer in Antimicrobial Resistance Battle
- New CE-Marked Hepatitis Assays to Help Diagnose Infections Earlier
- 1 Hour, Direct-From-Blood Multiplex PCR Test Identifies 95% of Sepsis-Causing Pathogens
- Mouth Bacteria Test Could Predict Colon Cancer Progression
- Unique Metabolic Signature Could Enable Sepsis Diagnosis within One Hour of Blood Collection
- Groundbreaking Diagnostic Platform Provides AST Results With Unprecedented Speed
- Simple Blood Test Combined With Personalized Risk Model Improves Sepsis Diagnosis
- Blood Analysis Predicts Sepsis and Organ Failure in Children
- TB Blood Test Could Detect Millions of Silent Spreaders
- New Blood Test Cuts Diagnosis Time for Nontuberculous Mycobacteria Infections from Months to Hours
- New Tuberculosis Test to Expand Testing Access in Low- and Middle-Income Countries
- Rapid Test Diagnoses Tropical Disease within Hours for Faster Antibiotics Treatment
- Rapid Molecular Testing Enables Faster, More Targeted Antibiotic Treatment for Pneumonia
- Rapid AST Platform Provides Targeted Therapeutic Results Days Faster Than Current Standard of Care
- New Analysis Method Detects Pathogens in Blood Faster and More Accurately by Melting DNA