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Alarmingly poor performance in Chlamydia trachomatis point-of-care testing
  1. Laura van Dommelen1,
  2. Frank H van Tiel1,
  3. Sander Ouburg1,2,
  4. Elfi E H G Brouwers3,
  5. Peter H W Terporten1,
  6. Paul H M Savelkoul4,
  7. Servaas A Morré1,2,
  8. Cathrien A Bruggeman1,
  9. Christian J P A Hoebe1,3
  1. 1Department of Medical Microbiology, Maastricht Infection Centre, Maastricht University Medical Centre, School for Public Health and Primary Care (CAPHRI), Maastricht, The Netherlands
  2. 2Department of Pathology, Laboratory of Immunogenetics, Section Immunogenetics of Infectious Diseases, VU University Medical Center, De Boelelaan, Amsterdam, The Netherlands
  3. 3Department of Infectious Diseases, South Limburg Public Health Service, Geleen, The Netherlands
  4. 4Department of Medical Microbiology and Infection Control, VU University Medical Center, De Boelelaan, Amsterdam, The Netherlands
  1. Correspondence to Laura van Dommelen, Department of Medical Microbiology, Maastricht Infection Centre, Maastricht University Medical Centre, School for Public Health and Primary Care (CAPHRI), PO Box 5800, 6202 AZ Maastricht, The Netherlands; lauravandommelen{at}yahoo.com

Abstract

Background Infection by Chlamydia trachomatis (CT) is the most prevalent sexually transmitted infection (STI) world wide. The most frequently used diagnostic test for CT is a nucleic acid amplification test (NAAT), which is highly sensitive and specific. To further shorten time delay until diagnosis has been made, in order to prevent CT spread, the use of point-of-care (POC) tests may be the way forward.

Objectives The diagnostic performance of three POC tests, Handilab-C, Biorapid CHLAMYDIA Ag test and QuickVue Chlamydia test, was evaluated and compared with NAAT.

Methods All women, above the age of 16 years, attending for a consultation at an STI clinic between September 2007 and April 2008, were asked to participate. Women were asked to complete a short questionnaire and to collect six self-taken vaginal swabs (SVS). SVS 2 was used for NAAT and SVS 3 to 5 were randomised for the different POC tests. SVS 1 and 6 were used for determining quantitative CT load to validate the use of successive SVS. All POC tests were performed without knowledge of NAAT results. NAAT was used as the ‘gold standard’.

Results 772 women were included. CT prevalence was 11% in our population. Sensitivities of the Biorapid CHLAMYDIA Ag test, QuickVue Chlamydia and Handilab-C test were 17%, 27% and 12%, respectively.

Conclusions The evaluated POC tests, owing to their very low sensitivities, are not ready for widespread use. These results underline the need for good-quality assurance of POC tests, especially in view of the increased availability of these tests on the internet.

  • Point of care test
  • Chlamydia trachomatis
  • NAAT
  • sensitivity and specificity
  • PCR
  • same day testing
  • screening
  • std control
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Footnotes

  • Linked articles: 044719.

  • Independence of researchers All authors were independent, and worked independently from the distributors of the tests.

  • Access to data All authors had full access to all of the data in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis.

  • Data sharing technical appendix, statistical code, and dataset available from the corresponding author at: f.van.tiel{at}mumc.nl

  • Funding This study was not funded. All rapid tests were kindly and unrestrictedly provided by the distributors.

  • Competing interests None.

  • Ethics approval This study was conducted with the approval of the Maastricht University Medical Centre, Maastricht, The Netherlands (MEC-06-4-004).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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