Simultaneous Evaluation of Diagnostic Assays for Pharyngeal and Rectal Neisseria gonorrhoeae and Chlamydia
Sarah B Doernberg1, Lauren Komarow2, Thuy Tien T Tran2
1University of California, San Francisco, California, USA.
Background:
Pharyngeal and rectal Neisseria gonorrhoeae and Chlamydia trachomatis play important roles in infection and antibacterial resistance transmission, but no US Food and Drug Administration (FDA)-cleared assays for detection at these sites existed prior to this study. The objective was to estimate performance of assays to detect those infections in pharyngeal and rectal specimens to support regulatory submission.
Methods:
We performed a cross-sectional, single-visit study of adults seeking sexually transmitted infection testing at 9 clinics in 7 states. We collected pharyngeal and rectal swabs from participants. The primary outcome was positive and negative percent agreement for detection of N. gonorrhoeae and C. trachomatis for 3 investigational assays compared to a composite reference. Secondary outcomes included positivity as well as positive and negative predictive values and likelihood ratios. Subgroup analyses included outcomes by symptom status and sex.
Results:
A total of 2598 participants (79% male) underwent testing. We observed N. gonorrhoeae positivity of 8.1% in the pharynx and 7.9% in the rectum and C. trachomatis positivity of 2.0% in the pharynx and 8.7% in the rectum. Positive percent agreement ranged from 84.8% to 96.5% for different anatomic site infection combinations, whereas negative percent agreement was 98.8% to 99.6%.
Conclusions:
This study utilized a Master Protocol to generate diagnostic performance data for multiple assays from different manufacturers in a single study population, which ultimately supported first-in-class FDA clearance for extragenital assays. We observed very good positive percent agreement when compared to a composite reference method for the detection of both pharyngeal and rectal N. gonorrhoeae and C. trachomatis.
Clinical Trials Registration:
NCT02870101.
Insights
New diagnostic assays accurately detect Neisseria gonorrhoeae and Chlamydia trachomatis in throat and rectal infections. This study supported the first FDA clearance for extragenital testing, improving STI diagnosis.
Area of Science:
- Microbiology
- Infectious Diseases
- Diagnostics
Background:
- Pharyngeal and rectal infections of Neisseria gonorrhoeae and Chlamydia trachomatis are critical for transmission and antimicrobial resistance.
- No FDA-cleared assays were available for detecting these infections at extragenital sites prior to this research.
Purpose of the Study:
- To evaluate the performance of investigational assays for detecting Neisseria gonorrhoeae and Chlamydia trachomatis in pharyngeal and rectal specimens.
- To generate data supporting regulatory submission for new diagnostic tests.
Main Methods:
- A cross-sectional study involving 2598 adults seeking STI testing across 9 clinics.
- Collection of pharyngeal and rectal swabs for analysis using 3 investigational assays against a composite reference standard.
- Analysis of primary outcomes including positive and negative percent agreement, and secondary outcomes like positivity rates and predictive values.
Main Results:
- Neisseria gonorrhoeae positivity was 8.1% (pharynx) and 7.9% (rectum); Chlamydia trachomatis positivity was 2.0% (pharynx) and 8.7% (rectum).
- Positive percent agreement for the assays ranged from 84.8% to 96.5%.
- Negative percent agreement was high, ranging from 98.8% to 99.6%.
Conclusions:
- The study successfully generated diagnostic performance data for extragenital Neisseria gonorrhoeae and Chlamydia trachomatis detection.
- The findings supported the first-in-class FDA clearance for extragenital diagnostic assays.
- Excellent agreement was observed between the investigational assays and the composite reference method.
