ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2020
Simultaneous Evaluation of Diagnostic Assays for Pharyngeal and Rectal Neisseria gonorrhoeae and Chlamydia trachomatis Using a Master Protocol.
Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02870101 (Performance of Nucleic Acid Amplification Tests for the Detection of Neisseria Gonorrhoeae and Chlamydia Trachomatis in Extragenital Sites), which is not on this map. Cited by 15 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Performance of Nucleic Acid Amplification Tests for the Detection of Neisseria Gonorrhoeae and Chlamydia Trachomatis in Extragenital Sites
Who cites it
15 citing papers in PubMed, 34 citations in OpenAlex.
- Highly-Specific Single-Stranded Oligonucleotides and Functional Nanoprobes for Clinical Determination of Chlamydia Trachomatis and Neisseria Gonorrhoeae Infections.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2023Article
- The Antibacterial Resistance Leadership Group: Scientific Advancements and Future Directions.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Article
- The Future Ain't What It Used to Be…Out With the Old…In With the Better: Antibacterial Resistance Leadership Group Innovations.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Article
- Priorities and Progress in Diagnostic Research by the Antibacterial Resistance Leadership Group.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Review
- Under the Hood: The Scientific Leadership, Clinical Operations, Statistical and Data Management, and Laboratory Centers of the Antibacterial Resistance Leadership Group.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Article
- Clinically Adjudicated Reference Standards for Evaluation of Infectious Diseases Diagnostics.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Article
- Diagnostic Tests for Detecting Chlamydia trachomatis and Neisseria gonorrhoeae in Rectal and Pharyngeal Specimens.Journal of clinical microbiology · 2022Review
- Urgent, Comprehensive Federal Action Needed To Stem Mortality and Medicare Costs Associated With Antimicrobial Resistance.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022Article
- Multicenter Comparison of Nucleic Acid Amplification Tests for the Diagnosis of Rectal and Oropharyngeal Chlamydia trachomatis and Neisseria gonorrhoeae Infections.Journal of clinical microbiology · 2022Article
- Alternative strategies forFrontiers in microbiology · 2022Review
- At-Home Specimen Self-Collection and Self-Testing for Sexually Transmitted Infection Screening Demand Accelerated by the COVID-19 Pandemic: a Review of Laboratory Implementation Issues.Journal of clinical microbiology · 2021Review
- Comparison between Aptima® assays (Hologic) and the CoBAS® 6800 system (Roche) for the diagnosis of sexually transmitted infections caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Mycoplasma genitalium.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2021Article
- Is the Patient Infected with SARS-CoV-2?Journal of clinical microbiology · 2021Article
- Point-of-Care Testing for Sexually Transmitted Infections: A Review of Recent Developments.Archives of pathology & laboratory medicine · 2020Review
- Analytical Evaluation of the Abbott RealTime CT/NG Assay for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Rectal and Pharyngeal Swabs.The Journal of molecular diagnostics : JMD · 2020Article
Corrections and comments
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Authors and funding
13 authors at 8 institutions in 1 country.
Funding
Abstract
backgroundPharyngeal 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.
methodsWe 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.
resultsA 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%.
conclusionsThis 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.