Cepheid Rectal Sample Validation Study
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/9/2019 |
| Start Date: | December 2013 |
| End Date: | April 2015 |
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.
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.
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.
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.
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
We found this trial at
2
sites
Pittsburgh, Pennsylvania 15213
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300 Halket St.
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
1-866-MyMagee (696-2433)
Magee-Womens Hospital of UPMC Magee-Womens Hospital of UPMC is a world-class center for both women's...
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