Alarmingly poor performance in Chlamydia trachomatis point of care testing

Laura van Dommelen (1) , Frank H van Tiel (1) , Sander Ouburg (2) , Elfi Ehg Brouwers (3) , Peter Hw Terporten (1) , Paul Hm Savelkoul (2) , Servaas A Morré (2) , Cathrien A Bruggeman (1) , Christian Jpa Hoebe (4)

1 MUMC - Maastricht University Medical Centre
2 VU University Medical Center [Amsterdam]
3 South Limbug Public Health Service
4 South Limburg Public Health Service

Objectives Infection by Chlamydia trachomatis (CT) is the most prevalent sexually transmitted infection (STI) worldwide. 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 could be the way forward. Three POC tests, Handilab-C, Biorapid CHLAMYDIA Ag test and QuickVue Chlamydia test, were evaluated regarding diagnostic performance in comparison with NAAT. Methods All women, above the age of 16 years old, consulting 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 6 self-taken vaginal swabs (SVS). SVS 2 was used for NAAT and SVS 3 to 5 were randomized 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 In our opinion, the evaluated POC tests, due to the very low sensitivities, are not ready for widespread use. Our results underline the need for good quality assurance of POC tests, especially in view of Internet possibilities.

Mots clés: CHLAMYDIA TRACHOMATIS; PCR; SAME DAY TESTING; SCREENING; STD CONTROL

Laura van Dommelen, Frank H van Tiel, Sander Ouburg, Elfi Ehg Brouwers, Peter Hw Terporten, et al.. Alarmingly poor performance in Chlamydia trachomatis point of care testing. Sexually Transmitted Infections, 2010, 86 (5), pp.355. ⟨10.1136/sti.2010.042598⟩. ⟨hal-00570214⟩