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BACKGROUND Cervical cancer screening with cytology suffers from low sensitivity, whereas the efficiency of human papillomavirus (HPV)-based screening is limited by low specificity. The authors evaluated a novel p16INK4a immunocytology approach in cervical cancer screening compared with HPV-based and cytology-based screening. METHODS In total, 2112 women aged 49 to 69 years from Shanxi, China were screened from March to July 2019. HPV testing, liquid-based cytology (LBC), and p16INK4a immunocytology were performed on samples from all women. Any positive result triggered a referral to colposcopy with biopsy, if indicated. Screening performance for detecting cervical intraepithelial neoplasia grade 2 and 3 or worse (CIN2+/CIN3+) was evaluated using multiple algorithms. RESULTS p16INK4a had a lower positive rate (10.0%) than LBC abnormality (vs 12.1%; P = .004) and a high-risk HPV positivity (21.4%; P < .001). For the detection of CIN3+, the relative sensitivity of p16INK4a compared with HPV and LBC was 0.93 (95% CI, 0.82-1.07) and 1.12 (95% CI, 0.95-1.32), respectively. The specificity of p16INK4a was significantly higher than that for HPV and LBC, with a relative specificity of 1.13 (95% CI, 1.11-1.16) and 1.02 (95% CI, 1.01-1.04), respectively. In addition, p16INK4a alone yielded a clinical performance very similar to that of the current mainstream strategy of using HPV16/18 with reflex cytology (ASC-US+, atypical squamous cells of undetermined significance or worse). The immediate risk of CIN3+ was 14.6% if p16INK4a results were positive and 0.2% if p16INK4a results were negative. CONCLUSIONS With minimal colposcopy referrals, p16INK4a screening demonstrated promising utility for risk stratification and yielded a better balance between sensitivity and specificity compared with HPV and LBC primary screening. Moreover, with accuracy and efficiency similar to what is achieved using mainstream cotest algorithms, p16 may simplify the screening practice. More evidence will be required before clinical recommendation.

BACKGROUND Liquid-based cytology (LBC) has been widely used for cervical cancer screening. Despite numerous studies and systematic reviews, to the authors' knowledge few large studies to date have focused on biopsy-confirmed cervical lesions and controversy remains concerning its diagnostic accuracy. The objective of the current study was to assess LBC for detecting biopsy-confirmed cervical intraepithelial neoplasia (CIN) and cancer. METHODS A pooled analysis of LBC using data from 13 population-based, cross-sectional, cervical cancer screening studies performed in China from 1999 to 2008 was performed. Participants (n = 26,782) received LBC and human papillomavirus testing. Women found to be positive on screening were referred for colposcopy and biopsy. The accuracy of LBC for detecting biopsy-confirmed CIN of type 2 or worse (CIN2+) as well as CIN type 3 or worse (CIN3+) lesions was analyzed. RESULTS Of 25,830 women included in the analysis, CIN2+ was found in 107 of 2612 with atypical squamous cells (4.1%), 142 of 923 with low-grade squamous intraepithelial neoplasia (15.4%), 512 of 784 with high-grade squamous intraepithelial neoplasia (65.3%), 29 of 30 with squamous cell carcinoma (96.7%), 4 of 27 with atypical glandular cells (14.8%), and 85 of 21,454 with normal cytology results (0.4%). No invasive cancers were found to have atypical squamous cells, atypical glandular cells, or cytologically normal slides. The overall sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of LBC for detecting CIN2+ were 81.0%, 95.4%, 38.3%, 99.3 %, and 94.9%, respectively. Although Hybrid Capture 2 was more sensitive than LBC, the specificity, positive predictive value, and overall accuracy of LBC were higher than those of Hybrid Capture2 at 85.2%, 18.6%, and 85.5%, respectively. CONCLUSIONS The results of the current study indicate that the performance of LBC can effectively predict the risk of existing CIN2+ and may be a good screening tool for cervical cancer prevention in a developing country. Cancer (Cancer Cytopathol) 2013;121:473-82. © 2013 American Cancer Society.

Liquid-based cytology (LBC) has been widely used for cervical cancer screening. Despite numerous studies and systematic reviews, to the authors' knowledge few large studies to date have focused on biopsy-confirmed cervical lesions and controversy remains concerning its diagnostic accuracy. The objective of the current study was to assess LBC for detecting biopsy-confirmed cervical intraepithelial neoplasia (CIN) and cancer.A pooled analysis of LBC using data from 13 population-based, cross-sectional, cervical cancer screening studies performed in China from 1999 to 2008 was performed. Participants (n = 26,782) received LBC and human papillomavirus testing. Women found to be positive on screening were referred for colposcopy and biopsy. The accuracy of LBC for detecting biopsy-confirmed CIN of type 2 or worse (CIN2+) as well as CIN type 3 or worse (CIN3+) lesions was analyzed.Of 25,830 women included in the analysis, CIN2+ was found in 107 of 2612 with atypical squamous cells (4.1%), 142 of 923 with low-grade squamous intraepithelial neoplasia (15.4%), 512 of 784 with high-grade squamous intraepithelial neoplasia (65.3%), 29 of 30 with squamous cell carcinoma (96.7%), 4 of 27 with atypical glandular cells (14.8%), and 85 of 21,454 with normal cytology results (0.4%). No invasive cancers were found to have atypical squamous cells, atypical glandular cells, or cytologically normal slides. The overall sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of LBC for detecting CIN2+ were 81.0%, 95.4%, 38.3%, 99.3 %, and 94.9%, respectively. Although Hybrid Capture 2 was more sensitive than LBC, the specificity, positive predictive value, and overall accuracy of LBC were higher than those of Hybrid Capture2 at 85.2%, 18.6%, and 85.5%, respectively.The results of the current study indicate that the performance of LBC can effectively predict the risk of existing CIN2+ and may be a good screening tool for cervical cancer prevention in a developing country.

BACKGROUND: Liquid-based cytology (LBC) has been compared with conventional cytology in numerous studies. In the current study of 2 LBC systems, the accuracy, rates of unsatisfactory cytology, and sufficiency of residual LBC specimens for Hybrid Capture 2 (HC2) HPV DNA testing were compared. METHODS: Eligible women ages 30 to 49 years were recruited for this cross-sectional population-based study in rural China. Women were assessed by visual inspection with acetic acid (VIA), LBC, and high-risk HPV HC2 DNA assay. Cervical specimens were preserved according to SurePath or ThinPrep protocols. LBC results were manually read. HC2 testing was performed on specimens with sufficient residual volume. Colposcopies and biopsies were performed on women who were VIA positive at the time of initial screening. Women with abnormal LBC or HC2 test results were called back for colposcopies and 4-quadrant cervical biopsies. RESULTS: Of 2005 eligible women, 972 were tested by SurePath and 1033 by ThinPrep. Compared with SurePath samples, ThinPrep samples had higher rates of unsatisfactory cytology (0.2% for SurePath and 1.5% for ThinPrep) and insufficient residual volume for HC2 (0.0% for SurePath and 18.2% for ThinPrep). SurePath samples yielded higher sensitivities and similar specificities for LBC and HC2 testing of residual specimens, but these differences were not determined to be significant by area-under-the-curve analysis (LBC performance: 0.89 for SurePath and 0.85 for ThinPrep; HC2 performance: 0.91 for SurePath and 0.89 for ThinPrep). CONCLUSIONS: Both methods yielded similar validity in detecting significant cervical lesions. However, SurePath samples yielded higher rates of satisfactory LBC slides and sufficient residual volume for HC2. Cancer (Cancer Cytopathol) 2011;000:000–000. V C 2011 American Cancer Society.