A 30-Min Nucleic Acid Amplification Point-of-Care Test for Genital Chlamydia trachomatis Infection in Women: A Prospective, Multi-center Study of Diagnostic Accuracy.
EBioMedicine
; 28: 120-127, 2018 Feb.
Article
in En
| MEDLINE
| ID: mdl-29396306
ABSTRACT
BACKGROUND:
Rapid Point-Of-Care Tests for Chlamydia trachomatis (CT) may reduce onward transmission and reproductive sexual health (RSH) sequelae by reducing turnaround times between diagnosis and treatment. The io® single module system (Atlas Genetics Ltd.) runs clinical samples through a nucleic acid amplification test (NAAT)-based CT cartridge, delivering results in 30min.METHODS:
Prospective diagnostic accuracy study of the io® CT-assay in four UK Genito-Urinary Medicine (GUM)/RSH clinics on additional-to-routine self-collected vulvovaginal swabs. Samples were tested "fresh" within 10days of collection, or "frozen" at -80°C for later testing. Participant characteristics were collected to assess risk factors associated with CT infection.RESULTS:
CT prevalence was 7.2% (51/709) overall. Sensitivity, specificity, positive and negative predictive values of the io® CT assay were, respectively, 96.1% (95% Confidence Interval (CI) 86.5-99.5), 97.7% (95%CI 96.3-98.7), 76.6% (95%CI 64.3-86.2) and 99.7% (95%CI 98.9-100). The only risk factor associated with CT infection was being a sexual contact of an individual with CT.CONCLUSIONS:
The io® CT-assay is a 30-min, fully automated, high-performing NAAT currently CE-marked for CT diagnosis in women, making it a highly promising diagnostic to enable specific treatment, initiation of partner notification and appropriately intensive health promotion at the point of care.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Chlamydia Infections
/
Chlamydia trachomatis
/
Point-of-Care Systems
/
Nucleic Acid Amplification Techniques
/
Genitalia
Type of study:
Clinical_trials
/
Diagnostic_studies
/
Etiology_studies
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limits:
Female
/
Humans
Language:
En
Journal:
EBioMedicine
Year:
2018
Document type:
Article