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Detroit, Michigan 48202


To evaluate if a rapid urine Nucleic Acid Amplification Testing (NAAT) is non-inferior to the traditional swab NAAT for gonorrhea and chlamydia when performed in the Emergency Department.

Study summary:

All patients presenting to the Emergency Department during the study period who are tested for gonorrhea and chlamydia by the traditional swab NAAT will concurrently have their urine tested for gonorrhea and chlamydia using the Cepheid GeneXpert rapid NAAT. The result of both tests will be compared to determine if the rapid assay is non-inferior to the current traditional NAAT. Both the traditional and Cepheid GeneXpert rapid NAAT are FDA and CDC approved for evaluation of gonorrhea and chlamydia. However, the Cepheid GeneXpert rapid NAAT has not been prospectively validated in the Emergency Department setting. We intend for both the provider obtaining the sample and the technician running the rapid assay sample to be blinded to the result of the traditional NAAT. The Cepheid GeneXpert rapid NAAT will not be used in patient care decisions.


Inclusion Criteria: - Clinical concern for gonorrhea and/or chlamydia infection - Concurrent testing for gonorrhea and chlamydia using traditional NAAT assay Exclusion Criteria: - age <18 years



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Location Contact:

Detroit, Michigan 48202
United States

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Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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