title: A field evaluation of a new molecular-based point-of-care test for chlamydia and gonorrhoea in remote Aboriginal health services in Australia.
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 1mL of urine, four steps, 1min specimen preparation and 90min to result. ICTs required 15mL of urine, eight steps, 18min preparation and 10-15min to result.
  
  
  CONCLUSIONS
  The accuracy and operational benefits of GeneXpert CT/NG make it very suitable in these settings where delays to treatment are encountered.
authors.affiliation: The Kirby Institute, Wallace Wurth Building, UNSW Australia, Sydney, NSW 2052, Australia.
authors.forename: Louise M
authors.initials: LM
authors.lastname: Causer
authors.affiliation: The Kirby Institute, Wallace Wurth Building, UNSW Australia, Sydney, NSW 2052, Australia.
authors.forename: Belinda
authors.initials: B
authors.lastname: Hengel
authors.affiliation: The Kirby Institute, Wallace Wurth Building, UNSW Australia, Sydney, NSW 2052, Australia.
authors.forename: Lisa
authors.initials: L
authors.lastname: Natoli
authors.affiliation: The Kirby Institute, Wallace Wurth Building, UNSW Australia, Sydney, NSW 2052, Australia.
authors.forename: Annie
authors.initials: A
authors.lastname: Tangey
authors.affiliation: The Kirby Institute, Wallace Wurth Building, UNSW Australia, Sydney, NSW 2052, Australia.
authors.forename: Steven G
authors.initials: SG
authors.lastname: Badman
authors.affiliation: Department of Microbiology, Division of Laboratory Services, The Royal Children's Hospital, 50 Flemington Road, Parkville, Vic 3052, Australia.
authors.forename: Sepehr N
authors.initials: SN
authors.lastname: Tabrizi
authors.affiliation: Queensland Paediatric Infectious Diseases (QPID) Laboratory, Queensland Children's Medical Research Institute, The University of Queensland, Herston, Qld 4029, Australia.
authors.forename: David
authors.initials: D
authors.lastname: Whiley
authors.affiliation: The Kirby Institute, Wallace Wurth Building, UNSW Australia, Sydney, NSW 2052, Australia.
authors.forename: James
authors.initials: J
authors.lastname: Ward
authors.affiliation: The Kirby Institute, Wallace Wurth Building, UNSW Australia, Sydney, NSW 2052, Australia.
authors.forename: John M
authors.initials: JM
authors.lastname: Kaldor
authors.affiliation: The Kirby Institute, Wallace Wurth Building, UNSW Australia, Sydney, NSW 2052, Australia.
authors.forename: Rebecca J
authors.initials: RJ
authors.lastname: Guy