Abstract:
Objective:To evaluate high-risk human papillomavirus (hrHPV) genotyping and viral load in predicting CIN (cervical intraepi -thelial neoplasia (CIN) grade 2 or worse in a Chinese rural area population with limited health resources. Methods:We performed a population- based prospective study and enrolled 2,257 women aged35to 64years from three rural screening sites of Jiangxi prov -ince. We conducted a hybrid capture (HC- 2) assay to predict viral load. A HC- 2 relative light unit (RLU) threshold of 10was set to differ-entiate samples between low (<10) and high ( ≥ 10) viral loads. We also carried out a HybriMax test to detect different hrHPV geno -types in the samples. Women exhibiting positive HC- 2 or HybriMax results underwent colposcopy and colposcopically directed biopsy. Women with negative or positive hrHPV test results but with normal biopsy or CIN1 were followed-up for 24months without interven-tion (n=2,211 ). We used histopathological findings as outcome. Results:Of the 2,211 women,1,636 provided complete follow-up data. Of the 132 women with a high viral load,4 (3. 03%) developed CIN2 + in the same period. The relative risk (RR) of CIN2 + for HC- 2 posi -tivity at baseline was 42. 24(95% CI=4. 76- 375 . 2). Of the 159 women who were positive for HPV16or HPV 18upon screening, 4 (2. 52%) progressed to CIN2 + (RR= 33. 06, 95% CI=3. 72- 293 . 9). The 2- year cumulative incidence rates of CIN 2 + did not significantly differ be -tween the high viral load group and the HPV16/18group. Conclusion: The risks of CIN 2 + progression were higher among women with a high viral load or HPV 16/18positivity than among women with negative hrHPV. Increasing the HC- 2 cut-off value to 10RLU or using HPV 16/18positivity may be similarly used to triage hrHPV- positive women for immediate colposcopy and comprehensive follow- up.Both approaches were equally predictive of the CIN 2 + risk in rural area. Increasing the HC-2 cut-off value to 10RLU may also help allo- cate health resources effectively.