Format

Send to

Choose Destination
EBioMedicine. 2018 Feb;28:120-127. doi: 10.1016/j.ebiom.2017.12.029. Epub 2018 Jan 10.

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.

Author information

1
Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK; Public Health England, National Infection Service, HIV/STI Department, Colindale, London NW9 5EQ, UK. Electronic address: eharding@sgul.ac.uk.
2
Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK. Electronic address: E.Cousins@soton.ac.uk.
3
Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK. Electronic address: christine.chow@imperial.ac.uk.
4
Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK. Electronic address: lphillip@sgul.ac.uk.
5
Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK. Electronic address: Catherine.Hall@lshtm.ac.uk.
6
Public Health England, National Infection Service, HIV/STI Department, Colindale, London NW9 5EQ, UK. Electronic address: Nicholas.Cooper@phe.gov.uk.
7
Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK. Electronic address: sfuller@sgul.ac.uk.
8
Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK. Electronic address: achyuta.nori@nhs.net.
9
Solent Sexual Health, University of Southampton, UK. Electronic address: prj467@gmail.com.
10
The Starling Clinic, Musgrove Park Hospital, Taunton and Somerset NHS Foundation Trust, UK. Electronic address: Sathish.Thomas-William@tst.nhs.uk.
11
56 Dean Street, Chelsea & Westminster Hospital NHS Foundation Trust, London, UK. Electronic address: gary.whitlock@chelwest.nhs.uk.
12
Sexual Health Hertfordshire Chelsea and Westminster NHS Foundation Trust, London SW10 9NH, UK; Central London Community Healthcare NHS Trust, London SW1E 6QP, UK. Electronic address: sarah.edwards17@nhs.net.
13
Atlas Genetics, Derby Court, Epsom Square, White Horse Business Park, Trowbridge, Wiltshire, BA14 0XG, UK. Electronic address: Marc.Green@atlasgenetics.com.
14
Atlas Genetics, Derby Court, Epsom Square, White Horse Business Park, Trowbridge, Wiltshire, BA14 0XG, UK. Electronic address: John.Clarkson@atlasgenetics.com.
15
Atlas Genetics, Derby Court, Epsom Square, White Horse Business Park, Trowbridge, Wiltshire, BA14 0XG, UK. Electronic address: Ben.Arlett@atlasgenetics.com.
16
Public Health England, National Infection Service, HIV/STI Department, Colindale, London NW9 5EQ, UK. Electronic address: kevin.dunbar@phe.gov.uk.
17
Public Health England, National Infection Service, HIV/STI Department, Colindale, London NW9 5EQ, UK. Electronic address: cmlowndes@googlemail.com.
18
Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK; Public Health England, National Infection Service, HIV/STI Department, Colindale, London NW9 5EQ, UK; Courtyard Clinic, St George's University Hospitals NHS Foundation Trust, London, UK, SW17 0QT, UK. Electronic address: ssadiq@sgul.ac.uk.

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.

KEYWORDS:

Chlamydia trachomatis; Diagnostic accuracy; Performance evaluation; Point-of-care; Rapid test; Risk factor

PMID:
29396306
PMCID:
PMC5897918
DOI:
10.1016/j.ebiom.2017.12.029
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Elsevier Science Icon for PubMed Central
Loading ...
Support Center