Multicenter Study

. 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

E M Harding-Esch¹, E C Cousins², S-L C Chow³, L T Phillips⁴, C L Hall⁵, N Cooper⁶, S S Fuller⁷, A V Nori⁸, R Patel⁹, S Thomas-William¹⁰, G Whitlock¹¹, S J E Edwards¹², M Green¹³, J Clarkson¹⁴, B Arlett¹⁵, J K Dunbar¹⁶, C M Lowndes¹⁷, S T Sadiq¹⁸

Affiliations

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.

PMID: 29396306
PMCID: PMC5897918
DOI: 10.1016/j.ebiom.2017.12.029

Multicenter Study

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

E M Harding-Esch et al. EBioMedicine. 2018 Feb.

. 2018 Feb:28:120-127.

doi: 10.1016/j.ebiom.2017.12.029. Epub 2018 Jan 10.

Authors

Affiliations

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.

PMID: 29396306
PMCID: PMC5897918
DOI: 10.1016/j.ebiom.2017.12.029

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.

PubMed Disclaimer

Figures

**Fig. 1**
Flow chart summarizing patient recruitment and sample collection results availability. CT, *Chlamydia trachomatis*; NAAT, Nucleic Acid Amplification Test. Flow diagram showing total number of eligible participants who consented to the study, ending with the total number of participants included in the final analyses. Samples were excluded where the participant did not meet the study eligibility criteria (n = 18); that did not have a clinic NAAT result available (n = 18), that were not tested on the io® CT assay (n = 16); or that had a final invalid result by the io® CT assay (n = 24).

See this image and copyright information in PMC

Cited by

Performance of the Atlas Genetics Rapid Test for Chlamydia trachomatis and Women's Attitudes Toward Point-Of-Care Testing.
Widdice LE, Hsieh YH, Silver B, Barnes M, Barnes P, Gaydos CA. Widdice LE, et al. Sex Transm Dis. 2018 Nov;45(11):723-727. doi: 10.1097/OLQ.0000000000000865. Sex Transm Dis. 2018. PMID: 29771869 Free PMC article.
Multiplex Detection of Infectious Diseases on Microfluidic Platforms.
Chen F, Hu Q, Li H, Xie Y, Xiu L, Zhang Y, Guo X, Yin K. Chen F, et al. Biosensors (Basel). 2023 Mar 21;13(3):410. doi: 10.3390/bios13030410. Biosensors (Basel). 2023. PMID: 36979622 Free PMC article. Review.
Performance of point-of-care tests for the detection of chlamydia trachomatis infections: A systematic review and meta-analysis.
Zhou Y, Jiang TT, Li J, Yin YP, Chen XS. Zhou Y, et al. EClinicalMedicine. 2021 Jun 18;37:100961. doi: 10.1016/j.eclinm.2021.100961. eCollection 2021 Jul. EClinicalMedicine. 2021. PMID: 34195578 Free PMC article.
DjinniChip: evaluation of a novel molecular rapid diagnostic device for the detection of Chlamydia trachomatis in trachoma-endemic areas.
Derrick TR, Sandetskaya N, Pickering H, Kölsch A, Ramadhani A, Mafuru E, Massae P, Malisa A, Mtuy T, Burton MJ, Holland MJ, Kuhlmeier D. Derrick TR, et al. Parasit Vectors. 2020 Oct 27;13(1):533. doi: 10.1186/s13071-020-04414-6. Parasit Vectors. 2020. PMID: 33109267 Free PMC article.
Diagnosis and Management of Uncomplicated Chlamydia trachomatis Infections in Adolescents and Adults: Summary of Evidence Reviewed for the 2021 Centers for Disease Control and Prevention Sexually Transmitted Infections Treatment Guidelines.
Geisler WM, Hocking JS, Darville T, Batteiger BE, Brunham RC. Geisler WM, et al. Clin Infect Dis. 2022 Apr 13;74(Suppl_2):S112-S126. doi: 10.1093/cid/ciac126. Clin Infect Dis. 2022. PMID: 35416965 Free PMC article.

See all "Cited by" articles

References

1. Abbott Abbott RealTime CT/NG. [Online] 2010. https://www.molecular.abbott/sal/en-us/staticAssets/ctng-8l07-91-us-fina... Package Insert. Available from.
1. Adams E.J., Ehrlich A., Turner K.M.E., Shah K. Mapping patient pathways and estimating resource use for point of care versus standard testing and treatment of chlamydia and gonorrhoea in genitourinary medicine clinics in the UK. BMJ Open. [Online] 2014;4(7):e005322. - PMC - PubMed
1. Aghaizu A., Reid F., Kerry S., Hay P.E. Frequency and risk factors for incident and redetected Chlamydia trachomatis infection in sexually active, young, multi-ethnic women: a community based cohort study. Sex. Transm. Infect. [Online] 2014;90(7):524–528. - PMC - PubMed
1. Alonzo T.A., Pepe M.S. Using a combination of reference tests to assess the accuracy of a new diagnostic test. Stat. Med. [Online] 1999;18(22):2987–3003. http://www.ncbi.nlm.nih.gov/pubmed/10544302 Available from. - PubMed
1. Atkinson L.M., Vijeratnam D., Mani R., Patel R. ‘The waiting game’: are current chlamydia and gonorrhoea near-patient/point-of-care tests acceptable to service users and will they impact on treatment? Int. J. of STD & AIDS. [Online] 2016;27(8):650–655. - PubMed

Publication types

Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Grants and funding

G0901608/MRC_/Medical Research Council/United Kingdom

LinkOut - more resources

Full Text Sources
Other Literature Sources
- The Lens - Patent Citations Database
- scite Smart Citations
Medical
- MedlinePlus Health Information

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

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

Affiliations

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

Authors

Affiliations

Abstract

Figures

Similar articles

Cited by

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical

Abstract

Figures

Similar articles

Cited by

References

Publication types

MeSH terms

Related information

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical