Alarmingly poor performance in Chlamydia trachomatis point-of-care testing.
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.


OBJECTIVE
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.
van Dommelen
Laura
L
Department of Medical Microbiology, Maastricht Infection Centre, Maastricht University Medical Centre, School for Public Health and Primary Care, Maastricht, The Netherlands. lauravandommelen@yahoo.com
van Tiel
Frank H
FH
Ouburg
Sander
S
Brouwers
Elfi E H G
EE
Terporten
Peter H W
PH
Savelkoul
Paul H M
PH
Morré
Servaas A
SA
Bruggeman
Cathrien A
CA
Hoebe
Christian J P A
CJ
D000293:Adolescent; D000328:Adult; D002690:Chlamydia Infections / Q000175:diagnosis*; D002692:Chlamydia trachomatis; D057210:Delayed Diagnosis; D005260:Female; D006801:Humans; D008875:Middle Aged; D021141:Nucleic Acid Amplification Techniques; D019095:Point-of-Care Systems / Q000592:standards*; D011934:Reagent Strips; D012680:Sensitivity and Specificity; D014626:Vaginal Smears; D055815:Young Adult
D011934:Reagent Strips