A field evaluation of a new molecular-based point-of-care test for chlamydia and gonorrhoea in remote Aboriginal health services in Australia
Louise M. Causer A I , Belinda Hengel A B , Lisa Natoli A C , Annie Tangey A D , Steven G. Badman A , Sepehr N. Tabrizi E F , David Whiley G , James Ward A H , John M. Kaldor A , Rebecca J. Guy A and on behalf of the TTANGO investigators
+ Author Affiliations
- Author Affiliations
A The Kirby Institute, Wallace Wurth Building, UNSW Australia, Sydney, NSW 2052, Australia.
B Apunipima Cape York Health Council, 186 McCoombe Street, Bungalow, Qld 4870, Australia.
C The Burnet Institute, 85 Commercial Road, Melbourne, Vic. 3004, Australia.
D Ngaanyatjarra Health Service, PO Box 644, Alice Springs, NT 0871, Australia.
E Department of Microbiology, Division of Laboratory Services, The Royal Children’s Hospital, 50 Flemington Road, Parkville, Vic 3052, Australia.
F Department of Obstetrics and Gynaecology, University of Melbourne, The Royal Women’s Hospital and Murdoch Children’s Research Institute, Carlton, Vic. 3053, Australia.
G Queensland Paediatric Infectious Diseases (QPID) Laboratory, Queensland Children’s Medical Research Institute, The University of Queensland, Herston, Qld 4029, Australia.
H Baker IDI, Central Australia, PO Box 1294, Alice Springs, Northern Territory 0871, Australia.
I Corresponding author. Email: lcauser@kirby.unsw.edu.au
Sexual Health 12(1) 27-33 https://doi.org/10.1071/SH14158
Submitted: 18 August 2014 Accepted: 21 October 2014 Published: 27 November 2014
Abstract
Background: Point-of-care (POC) tests could be important public health tools in settings with treatment delays and high rates of sexually transmissible infections (STIs). Use is limited due to suboptimal performance. The performance and ease-of-use of a new molecular-based POC test for simultaneous detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) was assessed, alongside two single-organism immunochromatographic tests (ICT). Methods: The evaluation occurred between May 2012 and March 2013 during community STI screens in two remote Aboriginal health services. Urine was tested with the GeneXpert®CT/NG and if sufficient volume, also with Diaquick CT and Gonorrhoea Card. The gold standard comparison was laboratory nucleic acid amplification testing (NAAT). Operational characteristics were also assessed. Results: Among 198 samples, GeneXpert CT sensitivity and specificity was 100% [95% confidence intervals (CI): 75.9–100] and 99.5% (95% CI: 96.5–100), and NG was 100% (95% CI: 96.5–100) and 100% (95% CI: 97.5–100), respectively. Among a sample subset, Diaquick CT (n = 104) sensitivity and specificity was 27.3% (95% CI: 7.3–60.7) and 66.7% (95% CI: 12.5–98.2), and Gonorrhoea Card (n = 29), was 66.7% (95% CI: 12.5–98.2) and 76.9% (95% CI: 56.0–90.2), respectively. GeneXpert required 1 mL of urine, four steps, 1 min specimen preparation and 90 min to result. ICTs required 15 mL of urine, eight steps, 18 min preparation and 10–15 min to result. Conclusion: The accuracy and operational benefits of GeneXpert CT/NG make it very suitable in these settings where delays to treatment are encountered.
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