title: [Handilab C Chlamydia for home testing is not what it claims].
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.
  
  
  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168 women was carried out because the first 50 tests provided by the Norwegian import company were found to be out of date and a new and better instruction form was provided.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%).
  
  
  CONCLUSIONS
  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.
authors: Olafiaklinikken, Legevaktetaten Oslo kommune, Grensen 5-7, 0159 Oslo. harald.moi@ulleval.no
authors: Harald
authors: H
authors: Moi
mesh_terms: D000328:Adult; D002690:Chlamydia Infections / Q000175:diagnosis*; D002692:Chlamydia trachomatis / Q000235:genetics; D005188:False Negative Reactions; D005189:False Positive Reactions; D005260:Female; D006801:Humans; D008297:Male; D021141:Nucleic Acid Amplification Techniques / Q000592:standards*; D010865:Pilot Projects; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D012648:Self Care; D012680:Sensitivity and Specificity; D014626:Vaginal Smears
chemical_list: D011933:Reagent Kits, Diagnostic