The effectiveness of HPV16 and HPV18 genotyping and cytology with different thresholds for the triage of human papillomavirus-based screening on self-collected samples

Abstract

Background/Objective Human papillomavirus (HPV) genotyping and cytology have been recommended for colposcopy triage, but it is unclear which combinations of high-risk HPV (hrHPV) types and cytology with various thresholds provide clinically useful information for the triage after primary HPV screening on self-collected samples. Method Chinese Multi-site Screening Trial (CHIMUST) database focused on self-collected samples was reviewed using the results of Cobas4800 HPV assay. Absolute risks of each genotype for cervical intraepithelial neoplasia 2 or worse/ 3 or worse (CIN2+/CIN3+) were calculated. Triage of atypical squamous cells of undetermined significance (ASCUS) or worse cytology was used as the comparator, and diagnostic accuracy for paired comparisons between algorithms was obtained using McNemar's test. Results A total of 10, 498 women were included, the overall prevalence of hrHPV, HPV16, HPV18, and Other hrHPV genotypes were 13.7%, 2.4%, 0.8%, and 10.5%, respectively. HPV16positive women had the highest absolute risk among various genotypes for CIN2+/CIN3+ whether in normal or abnormal cytology (ASCUS or worse) and among all age groups. When compared with the comparator, combining HPV16 positivity and/or high-grade squamous intraepithelial lesion (HSIL) or worse yielded higher specificity (97.7% vs. 97.0%, p<0.0001), similar sensitivity (90.7% vs. 96.3%, p = 0.256) for detection of CIN3+, and a

Re: Reflex cytology for triage of high‐risk human papillomavirus positive self‐sampled material in cervical cancer screening: a prospective cohort study

“…This was much lower than the sensitivity of cytology (74.8%) recorded in our recent study (Table 1), where CS and clinician samples were collected at a single visit. 2 The sensitivity of CS was also inferior to partial genotyping (HPV16 or HPV16/18) for triage (29.4% versus 49.6% and 52.6%, Table 1) for detecting CIN2+, as reported by Song et al 2 Unfortunately, HPV genotyping and its performance in the triage of HPVpositive CS was not included in this study. 1 Besides accuracy, the cost-effectiveness of CS should be considered.…”

“…Clinically, pregnant women with the more severe COVID-19 infection appear to prefer delivery by caesarean delivery rather than vaginal birth. [2][3][4] Therefore, it is possible that any beneficial effects of caesarean birth in reducing transmission of COVID-19 might not be apparent because the severity of COVID-19 infection was greater in these women. This selective bias would weaken the conclusions of current studies.…”

“…While our study shows that reflex cytology on self-samples cannot replace triage with regular cytology for HPVpositive women, because of the low sensitivity of 29.4% for detecting CIN2+, it is valuable as an additional method for triage. 2 With a positive predictive value (PPV) of 68.1% for detecting CIN2+ it is effective to refer HPV-positive women with abnormal cytology on self-sampling directly for colposcopic evaluation without the requirement of an extra visit to the general practitioner. A PPV of 21.2% for HPV-genotyping for types 16/18 on self-samples for detecting CIN2+ is not enough to refer these women directly for colposcopy.…”

Authors' reply re: Reflex cytology for triage of high‐risk human‐papillomavirus‐positive self‐sampled material in cervical cancer screening: a prospective cohort study

“…We thank Song et al for their insightful comments 1 on our article 2 and commend them for their study about human papillomavirus (HPV)‐genotyping on self‐samples and their analysis on different triage strategies for detecting cervical intraepithelial neoplasia grade 2 or worse (CIN2+) 3 . They report that cytology on physician‐sampled material has a sensitivity of 74.8% for detecting CIN2+, whereas HPV‐genotyping for types 16/18 has a sensitivity of 52.6% for detecting CIN2+.…”

Authors’ reply re: Reflex cytology for triage of high-risk human papillomavirus positive self-sampled material in cervical cancer screening: a prospective cohort study. (Response to BJOG-20-1479)

“…Dear editor/Sir, We thank Song et al for their insightful comments (1) on our article (2) and commend them for their study about human papillomavirus (HPV)-genotyping on self-samples and their analysis on different triage strategies for detecting cervical intraepithelial neoplasia grade 2 or worse (CIN2+) (3). They report that cytology on physician-sampled material has a sensitivity of 74.8% for detecting CIN2+, while HPV-genotyping for 16/18 has a sensitivity of 52.6% for detecting CIN2+.…”