Risk stratification for cervical precancer and cancer by DH3-HPV partial genotyping and cytology in women attending cervical screening: A retrospective cohort study.
To evaluate the effect of DH3-human papillomavirus (HPV) partial genotyping for risk stratification in cervical cancer screening, we conducted a post hoc analysis within a retrospective cohort of 7263 Chinese women aged 21-71 years who participated in population-based screening. The residual cytological samples at baseline were retested with DH3-HPV and Hybrid Capture 2 (HC2) assay after 3-year follow-up. Risk values with 95% confidence intervals (CIs) of cervical intraepithelial neoplasia (CIN) grade 3/2 or worse (CIN3+/CIN2+) were estimated based on HPV and cytology results. The report complies with the STROBE statement. Across every cytological result, risk estimates obtained from DH3-HPV and HC2 were similar or almost identical. By DH3-HPV partial genotyping, risks of CIN3+/CIN2+ were invariably higher for HPV16/18 than other high-risk HPV (hrHPV). Among women with normal cytology, immediate CIN3+ risks were 8.16% (95% CI = 4.19%-15.28%) for HPV16/18 positive and 0.48% (95% CI = 0.13%-1.73%) for other hrHPV positive. Among women with any abnormal cytology, immediate CIN3+ risks were 33.33% (95% CI = 22.24%-46.64%) for HPV16/18, and 13.33% (95% CI = 8.37%-20.56%) for other hrHPV. Among 5840 women completed 3-year follow-up, the cumulative CIN3+ risk was 25.56% (95% CI = 18.91%-33.59%) for HPV16/18 and 8.22% (95% CI = 6.02%-11.13%) for other hrHPV. Women with an HPV-negative result with DH3-HPV or HC2 test had very low cumulative 3-year CIN3+ risk (0.06%, 95% CI = 0.02%-0.17%), which was about one-tenth of women with normal cytology at baseline (0.62%, 95% CI = 0.45%-0.86%). Similar patterns were observed for the endpoint of CIN2+. These findings suggest that partial genotyping of DH3-HPV performs well in risk stratification, which can better balance the benefits and harms of cervical cancer screening.
Fu Y
，Li Y
，Li X
，Wang X
，Lü W
... -
《-》
The performance of human papillomavirus DNA detection with type 16/18 genotyping by hybrid capture in primary test of cervical cancer screening: a cross-sectional study in 10,669 Chinese women.
We aimed to assess the performance of DH3 human papillomavirus (HPV) assay, a newly developed hybrid capture technique that detects 14 high-risk HPVs with type 16/18 genotyping, as a primary test in cervical cancer screening.
In total 11,356 Chinese women aged 21-65 years participated in a cervical cancer screening programme using cytology (Thinprep, Hologic) and HPV testing (Cobas 4800 Test, Roche). Residual samples were used to detect HPV by DH3 HPV.
In total 10,669 women with valid results were included in the study. Of those, 135 were diagnosed as CIN2+, and 83 were diagnosed as CIN3+; 1056 women (9.9%) were DH3 HPV-positive and 255 (2.4%) of those were 16/18-positive, while 990 (9.3%) women were Cobas HPV-positive and 243 (2.3%) of those were 16/18-positive. DH3 HPV was non-inferior to Cobas HPV in identifying CIN1- and CIN2+ using predetermined thresholds (both p < 0.001). The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of DH3 HPV were 93.3% (95% confidence interval [CI] = 87.7-96.9), 91.2% (95%CI = 90.6-91.7), 12.0% (95%CI = 10.1-14.1) and 99.9% (95%CI = 99.8-100), respectively, similar to those of Cobas HPV (91.1%, 95%CI = 85.0-5.3; 91.8%, 95%CI = 91.2-92.3; 12.5%, 95%CI = 10.5-14.7; and 99.9%, 95%CI = 99.8-99.9, respectively), in identifying CIN2+ (all p > 0.05). When DH3 HPV and Cobas HPV were respectively used as primary testing in screening strategy, the performance of two strategies were similar in identifying CIN2+. The results were similar in identifying CIN3+.
Our data suggest that DH3 HPV performs similarly to Cobas HPV in identifying high-grade CIN in cervical cancer screening.
Zhao X
，Wu Q
，Wang X
，Fu Y
，Zhang X
，Tian X
，Cheng B
，Lu B
，Yu X
，Lan S
，Lu W
，Ma D
，Cheng X
，Xie X
... -
《-》
Performance of carcinogenic human papillomavirus (HPV) testing and HPV16 or HPV18 genotyping for cervical cancer screening of women aged 25 years and older: a subanalysis of the ATHENA study.
The ATHENA study was designed to assess the performance of carcinogenic human papillomavirus (HPV) testing and HPV16 or HPV18 genotyping compared with liquid-based cytology for cervical cancer screening in a large US population aged 21 years and older. We did a subanalysis of this population to compare the screening performance of the cobas HPV test versus liquid-based cytology in women aged 25 years and older, and assess management strategies for HPV-positive women.
Women aged 25 years or older who were attending routine cervical screening were enrolled from 61 clinical centres in 23 US states. Cervical specimens were obtained for liquid-based cytology and HPV DNA testing with two first-generation assays (Amplicor HPV test and Linear Array HPV genotyping test) and the second-generation cobas HPV test (with individual HPV16 and HPV18 detection). Colposcopy and diagnostic biopsies were done on women with atypical squamous cells of undetermined significance (ASC-US) or worse cytology, those who tested positive with either first-generation HPV test, and a random sample of women who tested negative for HPV and cytology. All women not selected for colposcopy received their results and exited the study. Participants and colposcopists were masked to cytology and HPV test results until the colposcopy visit was completed. The primary endpoint for this substudy was histologically confirmed cervical intraepithelial neoplasia grade 3 (CIN3) or worse. This study is registered with ClinicalTrials.gov, number NCT00709891; the study is in the follow-up phase, which is due to be completed in December, 2012.
From May 27, 2008, to Aug 27, 2009, 47,208 women were enrolled, of whom 41,955 met our eligibility criteria. Valid cobas HPV and liquid-based cytology test results were available for 40,901 women (97%), who were included in this analysis. Of these, 4275 women (10%) tested cobas HPV positive and 2617 (6%) had abnormal cytology. 431 women were diagnosed with CIN2 or worse and 274 with CIN3 or worse. In women who had colposcopy, the cobas HPV test was more sensitive than liquid-based cytology for detection of CIN3 or worse (252/274 [92·0%, 95% CI 88·1-94·6] vs 146/274 [53·3%, 95% CI 47·4-59·1]; difference 38·7%, 95% CI 31·9-45·5; p<0·0001). Addition of liquid-based cytology to HPV testing increased sensitivity for CIN3 or worse to 96·7% (265/274, 95% CI 93·9-98·3), but increased the number of screen positives by 35·2% (5783/40,901 vs 4275/40,901) compared with HPV testing alone. As a triage test to identify CIN3 or worse in HPV-positive women, detection of HPV16, HPV18, or both alone was equivalent to detection of ASC-US or worse alone in terms of sensitivity (150/252 [59·5%] vs 133/252 [52·8%]; p=0·11) and positive predictive value (PPV) (150/966 [15·5%] vs 133/940 [14·1%]; p=0·20). Among HPV-positive women, detection of HPV16, HPV18, or both or low-grade squamous intraepithelial lesion or worse cytology had better sensitivity (182/252 [72·2%]; p<0·0001) and similar PPV (182/1314 [13·9%]; p=0·70) for detection of CIN3 or worse than ASC-US or worse cytology alone. Furthermore, detection of HPV16, HPV18, or both or high-grade squamous intraepithelial lesion or worse cytology had higher sensitivity (165/252 [65·5%]; p=0·0011) and PPV (165/1013 [16·3%]; p=0·031) for detection of CIN3 or worse than ASC-US or worse cytology alone.
HPV testing with separate HPV16 and HPV18 detection could provide an alternative, more sensitive, and efficient strategy for cervical cancer screening than do methods based solely on cytology.
Roche Molecular Systems.
Castle PE
，Stoler MH
，Wright TC Jr
，Sharma A
，Wright TL
，Behrens CM
... -
《-》
ResearchGate
(全网免费下载)
钛学术
(全网免费下载)
