Xpert HPV Assay screening sample evaluation

• Research type

  Research Study

• Full title

  PROTOCOL 082B: Technical Evaluation of the Xpert® HPV Assay in a General Screening Population

• IRAS ID

  126851

• Contact name

  Mangesh Thorat

• Contact email

  m.thorat@qmul.ac.uk

• Sponsor organisation

  Cepheid

• Research summary

  
  The Xpert HPV Assay is a new qualitative, real-time Polymerase Chain Reaction (PCR) assay for the detection of specific types of high-risk human papillomavirus (HPV) DNA. The purpose of this study is to compare the results of the new test with those of cytology and two established HPV DNA tests.

  The study will use residual material from liquid based cytology specimens routinely collected in the cervical screening programme. Each specimen shall be anonymized/de-linked from its source subject by assignment of a study-specific identification number at the study Site. Aliquots will then be removed for testing by the new test, and two established HPV tests. The only patient demographic information recorded for each will be age.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  13/EM/0244

• Date of REC Opinion

  10 Jun 2013

• REC opinion

  Favourable Opinion