Article Text

PDF
Original article
Field evaluation of the CRT and ACON chlamydia point-of-care tests in a tropical, low-resource setting
  1. D S Hurly1,
  2. M Buhrer-Skinner1,
  3. S G Badman2,
  4. S Bulu3,
  5. S N Tabrizi4,5,6,
  6. L Tarivonda7,
  7. R Muller1,8
  1. 1Anton Breinl Centre for Public Health and Tropical Medicine, School for Public Health, Tropical Medicine and Rehabilitation Sciences, James Cook University, Queensland, Australia
  2. 2Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia
  3. 3KPH Clinic, Wan Smol Bag, Port Vila, Vanuatu
  4. 4Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Parkville, Victoria, Australia
  5. 5Murdoch Childrens’ Research Institute, Parkville, Victoria, Australia
  6. 6Department of Obstetrics and Gynaecology, University of Melbourne, Victoria, Australia
  7. 7Vanuatu Ministry of Health, Port Vila, Vanuatu
  8. 8Tropical Health Solutions Pty Ltd, Townsville, Queensland, Australia
  1. Correspondence to Dr Dermot Hurly, PO Box 585, Oneroa, Auckland, New Zealand; dermot.hurly{at}my.jcu.edu.au

Abstract

Objective To evaluate the clinical performance of two chlamydia point-of-care (POC) tests compared with a gold standard nucleic acid amplification testing (NAAT).

Methods Tests evaluated were the Chlamydia Rapid Test (CRT), Diagnostics for the Real World and the ACON Chlamydia Rapid Test Device, ACON Laboratories (ACON). Overall 226 men and 225 women in Port Vila, Vanuatu, participated in this prospective study in 2010. NAAT and POC testing was performed on samples of male urine and female vaginal swabs for 156 men and 223 women (CRT), and 133 men and 75 women (ACON).

Results The sensitivity and specificity of the CRT in men were 41.4% (95% CI 23.5% to 61.1%) and 89.0% (95% CI 82.2% to 93.8%), respectively, and in women 74.2% (95% CI 61.5% to 84.5%) and 95.7% (95% CI 91.3% to 98.2%), respectively; for ACON, they were 43.8% (95% CI 19.8% to 70.1%) and 98.3% (95% CI 93.9% to 99.8%) in men, and in women 66.7% (95% CI 22.3% to 95.7%) and 91.3% (95% CI 82.0% to 96.7%), respectively. Both tests were (absolutely) insensitive at organism loads less than 1000 (log=3) per mL or per swab; the CRT sensitivity was significantly lower at loads less than, compared with those greater than, 100 000 (log=5) per mL or per swab.

Conclusions The performance of both CRT and ACON is well below the levels stated by the manufacturers. The evaluated tests are unlikely to be helpful in clinical settings due to the high proportion of false-negatives that will go untreated and false-positives that will result in overtreatment and potential adverse social consequences.

  • Chlamydia Trachomatis
  • Testing
  • Chlamydia Infection
  • Developing World
  • Laboratory Methods

Statistics from Altmetric.com

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Linked Articles