Shanxi province cervical cancer screening study: A cross-sectional comparative trial of multiple techniques to detect cervical neoplasia

Objective. The aim of this study was to design a cervical cancer screening algorithm for the developing world that is highly sensitive for cervical in traepithelial neoplasia (CIN) II, III, and cancer and highly specific for C IN II and III, making it possible to ablate the transformation zone without histologic confirmation. Methods. In rural Shanxi Province, China, we examined 1997 women ages 35-45 . Each subject underwent a self-test for intermediate and high-risk HPV (by HC-II assay), fluorescence spectroscopy, a liquid-based Pap (read manually and by computer and used as a direct test for HPV), a visual inspection (V IA) diagnosis, and colposcopy with multiple cervical biopsies. Results. Mean age was 39.1 +/- 3.16 years, mean number of births was 2.6 +/ - 0.93. Based on tests administered, 4.3% subjects had greater than or equa l to CIN II. All subjects with greater than or equal to CIN II had either a ThinPrep ap, (greater than or equal to ASCUS) or a positive HPV direct tes t. The sensitivity and specificity for the detection of greater than or equ al to CIN II were, respectively, 83 and 86% for the HPV self-test, 95 and 8 5% for the HPV direct test, 94 and 78% for the ThinPrep Pap (greater than o r equal to ASCUS), 77 and 98% for the ThinPrep Pap ( greater than or equal to HGSIL), 94 and 9% for fluorescence spectroscopy, 71 and 74% for VIA, and 81 and 77% for colposcopy. Conclusion. Based on these data and the existing healthcare infrastructure in China, we believe that further refinement of primary HPV screening using centralized labs is indicated. Self-testing in the local villages may be e ffective with improvements in the devices and techniques. (C) 2001 Academic Press.