Xpress Xpert CT/NG
Research type
Research Study
Full title
Clinical Evaluation of the Xpert Xpress CT/NG Test in Male Urine and Female Urogenital Specimens
IRAS ID
291293
Contact name
Barbara Acca
Contact email
Sponsor organisation
Cepheid
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 4 months, 30 days
Research summary
This clinical study will test for Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) infections and it will include fresh first-catch voided urine collected from CT/NG symptomatic and asymptomatic male patients, age 18 years or older and fresh first-catch voided urine, patient-collected vaginal swab (collected in a clinical setting), clinician-collected vaginal swab, and endocervical swab specimens collected from symptomatic and asymptomatic female patients, age 18 years and older. This study will include at least one (1) near-patient testing site outside the United States.
Study specimens will be tested with the Xpert Xpress CT/NG test on-site in a near-patient setting. The remaining specimens will be shipped to a ref. Lab in the USA.
Performance for male urine specimens will be determined relative to a PIS algorithm
based on results from the Roche cobas CT/NG Test, the BD Max CT-GC-TV assay and the Abbott RealTime CT/NG Assay. Performance for female urogenital specimens will be determined relative to a PIS algorithm based on results from Roche
and BD.Summary of results
Study was cancelled prior to enrollment phase. No data was collected. No data to report.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
20/NE/0285
Date of REC Opinion
14 Jan 2021
REC opinion
Further Information Favourable Opinion