Harald Moi1. 1. Olafiaklinikken, Legevaktetaten Oslo kommune, Grensen 5-7, 0159 Oslo. harald.moi@ulleval.no
Abstract
BACKGROUND: The Norwegian Institute of Public Health recommends increased testing for genital chlamydia infection to halt an increasing incidence. A rapid home test claiming a "safety" of 98% was marketed in Norwegian pharmacies in 2005 for use in women. MATERIAL AND METHODS: Women attending the Olafia Clinic in Oslo for a sexual health check were asked to perform a Handilab C test themselves. Samples for the nucleid acid amplification test (NAAT) were thereafter taken and sent to the microbiology laboratory. The results were compared. RESULTS: In a pilot study, 80 of 88 women completed both tests. Four tests were positive according to NAAT, none of which were interpreted as positive by Handilab C. A new study including 168 women was carried out because the first 50 tests provided by the Norwegian import company were found to be out of date and a new and better instruction form was provided. Of the 157 women who completed both tests, 16 had positive NAAT results for C trachomatis; four of these were interpreted as positive by the Handilab C test and 9 as uncertain (sensitivity 25-57%). Half of the women were uncertain about how to interpret the test result and 13 who had a negative NAAT interpreted Handilab C as positive (positive predictive value 24%). INTERPRETATION: Most women had no problems taking the vaginal swab test, but Handilab C did not fulfil its claim to be a "safe" rapid test. The majority were uncertain about how to interpret the result or had false negative or false positive results.
BACKGROUND: The Norwegian Institute of Public Health recommends increased testing for genital chlamydia infection to halt an increasing incidence. A rapid home test claiming a "safety" of 98% was marketed in Norwegian pharmacies in 2005 for use in women. MATERIAL AND METHODS:Women attending the Olafia Clinic in Oslo for a sexual health check were asked to perform a Handilab C test themselves. Samples for the nucleid acid amplification test (NAAT) were thereafter taken and sent to the microbiology laboratory. The results were compared. RESULTS: In a pilot study, 80 of 88 women completed both tests. Four tests were positive according to NAAT, none of which were interpreted as positive by Handilab C. A new study including 168 women was carried out because the first 50 tests provided by the Norwegian import company were found to be out of date and a new and better instruction form was provided. Of the 157 women who completed both tests, 16 had positive NAAT results for C trachomatis; four of these were interpreted as positive by the Handilab C test and 9 as uncertain (sensitivity 25-57%). Half of the women were uncertain about how to interpret the test result and 13 who had a negative NAAT interpreted Handilab C as positive (positive predictive value 24%). INTERPRETATION: Most women had no problems taking the vaginal swab test, but Handilab C did not fulfil its claim to be a "safe" rapid test. The majority were uncertain about how to interpret the result or had false negative or false positive results.