Features and Benefits

  • Detects Mycoplasma genitalium including azithromycin
           resistance
  • Detects Trichomonas vaginalis
  • Diagnosis within 1.5 hours
  • Validated on LightCycler 480 (Roche), Rotor-Gene Q (QIAGEN),
          ABI7500 (Applied Biosystems) and CFX96 (Bio-Rad)
  • Positive and Negative Control included
  • Internal Control included

Overview

Mycoplasma genitalium is a bacterial STI with clinical symptoms and potential sequelae similar to Chlamydia trachomatis  infections [1]. The efficacy of the current treatment regimen of M. genitalium infections with azithromycin is hampered by resistance rates of more than 30% in certain populations. Trichomonas vaginalis is a protozoan STI. Trichomoniasis is a common cause of vaginitis in women and urethritis in men although a substantial proportion of T. vaginalis infections are asymptomatic.

The RealAccurate® TVMGres PCR Kit is able to detect T. vaginalis, M. genitalium and at the same time mutations in the 2058/2059 region of M. genitalium 23S rRNA conferring azithromycin resistance.

Targets

  • M. genitalium 
  • M. genitalium azithromycin resistant strains
  • T. vaginalis

Detection systems

Detection is performed on real-time PCR instruments capable to detect FAM, CAL Fluor Orange 560, CAL Fluor Red 610 and TYE665.

Analysis and Interpretation

Real-time PCR with a combination of Taqman Probe and Molecular Beacon detection is used for interpretation.

The Internal Control reaction controls for the quality of the used sample and controls for inhibiting factors present in the sample. A negative test result is validated by a positive Internal Control result.

A Positive Control is included in the RealAccurate® TVMGres PCR kit as a control for the assay procedure.

Procedure

The RealAccurate® TVMGres PCR Kit is a sensitive real-time PCR test enabling detection and differentiation of T. vaginalis, M. genitalium and the most prevalent mutations in M. genitalium strains conferring azithromycin resistance.

The kit components include a ready to use mix of primers and probes and a master mix containing a hot start Taq DNA polymerase. An Internal Control is included to distinguish false negatives due to inhibition from true negatives. Kit components have been extensively validated to ensure the detection of low copy numbers of T. vaginalis and M. genitalium nucleic acid.

Validation

The RealAccurate® TVMGres PCR Kit is validated on LightCycler® 480 (Roche), Rotor-Gene® Q (QIAGEN), ABI7500 (Applied Biosystems) and CFX96™ (Bio-Rad) for amplification after nucleic acid extraction using NucliSENS® easyMAG® (bioMérieux), MagNA Pure 96 (Roche) or QIAamp® DNA Blood Kit (QIAGEN) of urine and vaginal swab samples.

Internal Amplification Control

The Internal Control supplied in the RealAccurate® TVMGres PCR Kit is a M13 bacteriophage solution and is supplied as a control for lysis, DNA extraction, real-time PCR performance and to check for possible PCR inhibition.

Quality

  • Designed and manufactured under EN ISO 13485:2012
  • CE-IVD marked
  • Validated on QCMD panels
  • Validated on clinical samples

References