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Performance of Nucleic Acid Amplification Tests for the Detection of NG and CT

NCT02870101 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2767

Last updated 2019-05-15

Study results available
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Summary

The purpose of this study was to use participant samples to simultaneously evaluate three nucleic acid amplification tests (NAATs) diagnostic platforms.

Conditions

  • Neisseria Gonorrhoeae Infection
  • Chlamydia Trachomatis Infection
  • Sexually Transmitted Infections

Interventions

DIAGNOSTIC_TEST

Nucleic acid amplification test 1 for NG and CT

A combination test using real-time PCR to detect DNA from NG and CT.

DIAGNOSTIC_TEST

Nucleic acid amplification test 2 for NG and CT

A combination test using target amplification to detect RNA from NG and CT.

DIAGNOSTIC_TEST

Nucleic acid amplification test 3 for NG and CT

A combination test using real-time PCR to detect DNA from NG and CT.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Jeffrey D Klausner, MD, MPH · UCLA David Geffen School of Medicine and Fielding School of Public Health

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-10
Primary Completion
2018-03-12
Completion
2018-03-12
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02870101 on ClinicalTrials.gov