Validating Aptima® Mycoplasma genitalium

• Research type

  Research Study

• Full title

  A study to validate equivalent efficacy of clinician taken and self-taken swabs for detecting Mycoplasma genitalium with the Aptima® Mycoplasma genitalium assay and determine the prevalence in symptomatic women attending a department of Genitourinary Medicine.

• IRAS ID

  113476

• Contact name

  Peter Muir

• Contact email

  peter.muir@phe.gov.uk

• Sponsor organisation

  Hologic Inc

• Duration of Study in the UK

  0 years, 11 months, 31 days

• Research summary

  This study aims to evaluate the use of clinician-taken and self taken vulvo-vaginal swabs for the detection of M. gentialium in symptomatic women. M.genitalium is a sexually transmitted infection associated with serious complications and increases the risk of transmission and accquistion of HIV.

  Culture of MG is slow and expensive and not routinely used resulting in patients being untreated unless the patient is treated for suspected or confirmed concurrent chlamydia or gonorrhoea infection. However antimicrobial therapy doses used for chlamydia and gonorrhoea may be suboptimal for MG, potentially leading to incompletely treated MG infection, and development of antimicrobial resistance in MG. A validated commercial assay would enable high throughput rapid testing and laboratory guided antibiotic therapy.

• REC name

  HSC REC B

• REC reference

  17/NI/0161

• Date of REC Opinion

  15 Aug 2017

• REC opinion

  Favourable Opinion