Abstract
Context Human papillomavirus (HPV) testing is widely used in cervical cancer screening in women; however, its efficiency in triaging women with atypical squamous cells of undetermined significance (ASC-US) needs to be validated. Objective To evaluate the performance of HPV16/18 in the triage of women with ASC-US. Methods Women presenting for routine cervical cancer screening had cervical specimens collected, with which both liquid-based cytology (LBC) and hrHPVs were examined; those with ASC-US cytology underwent colposcopy. HPV16/18 and 12 other types were tested with domestic hybridization capture and chemiluminescence signal amplification (DH3). Performance characteristics of HPV test (sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) for identification of cervical intraepithelium neoplasma (CIN) grade 2 or worse (CIN2+), and CIN grade 3 or worse (CIN3+)) were determined using standard statistical tests. Results 317 women with ASC-US were eligible for the study. HrHPV prevalence was 15.77% (50/317); HPV16/18 prevalence was 3.61% (20/317). Sensitivity and specificity of HPV16/18 for detection of CIN 2+ were 64.71% and 97% and 64.29% and 96.37% for detection of CIN 3+, respectively. The positive predictive values (PPVs) and negative predictive values (NPVs) of HPV16/18 were 55.00% and 97.98% for CIN2+ and 45.00% and 98.32% for CIN3+, respectively. Conclusion HPV16/18 can be considered as an effective method to triage women with ASC-US as its good clinical performance. Trial Registration This trial is registered with Henan Cancer Hospital Medical Ethics Committee on July 5, 2016 (http://www.anti-cancer.com.cn), with registry no.: 2016037.
Highlights
Cervical cancer screening methodology has evolved and benefited from detection of high-risk human papillomavirus as Human papillomavirus (HPV) infection has been verified as the leading carcinogenesis of cervical cancer [1, 2]
HrHPV DNA genotypes were generally categorized as 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68, among which HPV16 and HPV18 were generally recognized as the highest risk of cervical cancer genesis [4,5,6,7]
Cytology is still widely used in cervical cancer screening, and Atypical squamous cells of undetermined significance (ASC-US) triage remains ambiguous
Summary
Cervical cancer screening methodology has evolved and benefited from detection of high-risk human papillomavirus (hrHPV) as HPV infection has been verified as the leading carcinogenesis of cervical cancer [1, 2]. How to refer women with ASC-US for further diagnosis has a dispute, for a repeatable cytological examination, HPV test, or further colonoscopy. As it is known, hrHPV DNA genotypes were generally categorized as 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68, among which HPV16 and HPV18 were generally recognized as the highest risk of cervical cancer genesis [4,5,6,7]. First delivery (yr) Pregnancy times Delivery times Live birth times. Categorical variables Educational level Elementary school and below Middle school and higher Smoking (never) Drinking (never) Normal marriage status Condom usage Frequency (%) 8 (2.5)
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