Emergency Department, Rapid Assessment for Sexually Transmitted Infection
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | March 2015 |
| End Date: | September 2015 |
| Contact: | Joseph Miller, MD |
| Phone: | 313-916-5419 |
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.
the traditional swab NAAT for gonorrhea and chlamydia when performed in the Emergency
Department.
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.
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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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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