Ignite Creation Date:
2024-05-06 @ 2:38 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02099760
Status:
COMPLETED
Last Update Posted:
2019-02-07
First Post:
2014-03-12
Brief Title:
Cepheid Rectal Sample Validation Study
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
A Validation Study of the Cepheid Xpert CTNG for Detecting Chlamydia Trachomatis and Neisseria Gonorrhoeae in Rectal Samples
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to validate Xpert CTNG 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 CTNG will have greater sensitivity than culture in detecting Neisseria gonorrhoeae in rectal samples The investigators also hypothesize that Xpert CTNG will be equivalent to the Gen-Probe APTIMA Combo2 AC2 in detecting Chlamydia trachomatis and Neisseria gonorrhoeae in rectal samples
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 CTNG will have greater sensitivity than culture in detecting Neisseria gonorrhoeae in rectal samples The investigators also hypothesize that Xpert CTNG will be equivalent to the Gen-Probe APTIMA Combo2 AC2 in detecting Chlamydia trachomatis and Neisseria gonorrhoeae in rectal samples
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5U01AI068633-04 | NIH | None | httpsreporternihgovquickSearch5U01AI068633-04 |