Introduction/Background*The aim of this study was to determine the efficiency of the Hybrid Capture 2 (HC2; Digene, Qiagen, Hilden Germany) human papillomavirus (HPV) assay for the detection of cervical neoplasia compared to conventional cytology testing.

Methodology Two hundred consecutive eligible women evaluated in the Outpatient department at the University Clinic of Gynecology and Obstetrics in Skopje aged 30-64 years, were informed and offered to be sampled with the HC2 test in addition to any tests ordered by their attending physician free of charge and strictly on voluntary basis. Written consent was obtained from all participating women. The attending physicians were blinded for the results of the HC2 tests and any and all medical decisions regarding patient evaluation/treatment were based on the cytology results.

Result(s)*The average age of the women included was 44±11 years, ranging from 30 to 64. A total of 200 cytology smears, 200 HC2 tests, 76 (38%) colposcopy examinations, 45 PCR (22.5%) based HPV tests and 50 (25%) cervical biopsies were performed. The detection rate for histology verified CIN2+ lesions for the HC2 based algorithm in the studied population, when compared with the conventional cytology-based algorithm was 19/22 (86.36%), while the detection rate for histology verified CIN3+ lesions was 14/14 (100%). The sensitivity, specificity, LR+ and LR- of the HC2 test in the detection of CIN2+ lesions were 88%, 87.5%, 7.04 and 0.13, respectively, giving the test an accuracy of 87.72%. Using the conventional cytology-based algorithm required 76 referrals for colposcopy, 45 referrals for PCR based HPV detection and 50 referrals for cervical biopsy, compared to 41 cytology test, 33 colposcopy referrals and 22 biopsy referrals.

Conclusion*Implementing a HC2 based cervical cancer screening algorithm could potentially reduce the number of colposcopy/biopsy referrals by over 50% without a substantial impact on the CIN2+ detection rate and no impact on the CIN3+ detection rate. This in turn decreases the associated costs of screening, decreases the number of unnecessary diagnostic procedures and, could increases patient comfort, satisfaction and adherence to the screening program