Louise M Causer1, Belinda Hengel1, Lisa Natoli1, Annie Tangey1, Steven G Badman1, Sepehr N Tabrizi2, David Whiley3, James Ward1, John M Kaldor1, Rebecca J Guy1. 1. The Kirby Institute, Wallace Wurth Building, UNSW Australia, Sydney, NSW 2052, Australia. 2. Department of Microbiology, Division of Laboratory Services, The Royal Children's Hospital, 50 Flemington Road, Parkville, Vic 3052, Australia. 3. Queensland Paediatric Infectious Diseases (QPID) Laboratory, Queensland Children's Medical Research Institute, The University of Queensland, Herston, Qld 4029, Australia.
Abstract
UNLABELLED: 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. CONCLUSION: The accuracy and operational benefits of GeneXpert CT/NG make it very suitable in these settings where delays to treatment are encountered.
UNLABELLED: 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. CONCLUSION: The accuracy and operational benefits of GeneXpert CT/NG make it very suitable in these settings where delays to treatment are encountered.
Authors: Lisa Natoli; Rebecca J Guy; Mark Shephard; Louise Causer; Steven G Badman; Belinda Hengel; Annie Tangey; James Ward; Tony Coburn; David Anderson; John Kaldor; Lisa Maher Journal: PLoS One Date: 2015-12-29 Impact factor: 3.240
Authors: Menne Bartelsman; Henry J C de Vries; Maarten F Schim van der Loeff; Leslie O A Sabajo; Jannie J van der Helm Journal: BMC Infect Dis Date: 2016-11-03 Impact factor: 3.090
Authors: Emma M Harding-Esch; Achyuta V Nori; Aseel Hegazi; Marcus J Pond; Olanike Okolo; Anthony Nardone; Catherine M Lowndes; Phillip Hay; S Tariq Sadiq Journal: Sex Transm Infect Date: 2017-02-03 Impact factor: 3.519