Cepheid Rectal Sample Validation Study

A Validation Study of the Cepheid Xpert CT/NG for Detecting Chlamydia Trachomatis and Neisseria Gonorrhoeae in Rectal Samples

The purpose of this study is to validate Xpert CT/NG for the detection of CT and GC in rectal samples as part of the PA DOH and CLIA requirements. The evaluation of samples obtained from the pharynx is exploratory and will provide new information on the frequency of pharyngeal infection due to CT and GC.

A secondary objective will be to evaluate the prevalence of Trichomonas vaginalis in vaginal and rectal samples using both the Xpert system and AC2 to assess whether women positive for this pathogen rectally usually or always have vaginal infection due to this pathogen.

The investigators hypothesis is that real-time PCR (polymerase chain reaction) amplification testing with the Cepheid Xpert CT/NG will have greater sensitivity than culture in detecting Neisseria gonorrhoeae in rectal samples. The investigators also hypothesize that Xpert CT/NG will be equivalent to the Gen-Probe APTIMA Combo2 (AC2) in detecting Chlamydia trachomatis and Neisseria gonorrhoeae in rectal samples.

Study Overview

• Status: Completed
• Conditions: Chlamydia; Gonorrhea; Trichomonas
• Intervention / Treatment: Device: STD testing (GC/Ct/trich)

Detailed Description

Because of its high sensitivity and specificity, NAAT testing has largely replaced bacterial culture for the diagnosis of genital CT and GC in both males and females. NAAT assays have the greatest potential for detecting CT and GC in the rectum; however, no NAAT is currently cleared for use with extragenital specimens by the US Food and Drug Administration.

In order to comply with CLIA regulations, laboratories must perform in-house validations to use NAATs with rectal and pharyngeal specimens. There are multiple studies in the literature evaluating NAAT assays in diagnosing CT and GC in rectal and pharyngeal specimens using expanded reference standards, which includes positive culture result and secondary confirmatory NAAT assays. The proposed validation study is intended to provide data to support the use of NAAT for rectal and pharyngeal specimens.

• Study Type: Observational
• Enrollment (Actual): 402

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee-Womens Hospital of UPMC
    • Pittsburgh, Pennsylvania, United States, 15213
      • Allegheny County Health Department Sexually Transmitted Diseases Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects presenting for routine clinical care in an STD Clinic and/or subjects who are aware of the study and meet the inclusion/exclusion criteria.

Description

Inclusion Criteria:

1. Male and female participants aged 18 and older
2. Women or men who have a history of engaging in receptive anal intercourse
3. Willing to provide written informed consent for participation in this study

Exclusion Criteria:

1. Use of oral antibiotics in the past 7 days
2. Use of rectal douche or other rectal product in the past 24 hours
3. If female, use of a vaginal douche or vaginal product in the past 24 hours

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
STD testing (GC/Ct/trich)	Device: STD testing (GC/Ct/trich); Other Names: Cepheid Xpert CT/NG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rectal Gonorrhea/Chlamydia testing result	Compare the sensitivity and specificity of the Xpert NG to the AC2 and culture in detecting GC in rectal samples Compare the sensitivity and specificity of the Xpert CT to AC2 (and as necessary, for discrepant results, to Aptima CT assay) in detecting CT in rectal samples	approximately 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pharyngeal GC/Ct result	The evaluation of samples obtained from the pharynx is exploratory and will provide new information on the frequency of pharyngeal infection due to CT and GC.	approximately 7 days
Trichomonas Testing Results	evaluate the prevalence of Trichomonas vaginalis in vaginal and rectal samples using both the Xpert system and AC2	approximately 7 days

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Sharon Hillier, PhD, University of Pittsburgh/UPMC

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ACTUAL): April 1, 2015
• Study Completion (ACTUAL): April 1, 2015

Study Registration Dates

• First Submitted: March 12, 2014
• First Submitted That Met QC Criteria: March 26, 2014
• First Posted (ESTIMATE): March 31, 2014

Study Record Updates

• Last Update Posted (ACTUAL): February 7, 2019
• Last Update Submitted That Met QC Criteria: February 6, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: gonorrhea; trichomonas; chlamydia
• Additional Relevant MeSH Terms: Infections; Communicable Diseases; Sexually Transmitted Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Parasitic Diseases; Protozoan Infections; Neisseriaceae Infections; Chlamydiaceae Infections; Sexually Transmitted Diseases, Bacterial; Chlamydia Infections; Gonorrhea; Trichomonas Infections
• Other Study ID Numbers: PRO13100170; 5U01AI068633-04 (U.S. NIH Grant/Contract)