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
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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
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Three-year longitudinal data on the clinical performance of the Abbott RealTime High Risk HPV test in a cervical cancer screening setting.
Testing cervical smears for the presence of high-risk human papillomaviruses (hrHPV) increases the sensitivity for detecting women with underlying high-grade cervical intraepithelial neoplasia (CIN) and provides better and longer protection against invasive cervical cancer compared to cytology testing alone. The Abbott RealTime High Risk HPV test (RealTime) is a hrHPV DNA test with concurrent partial genotyping for HPV16 and HPV18 and aggregate detection of 12 other hrHPV types that have been extensively analytically and clinically evaluated over the last 6 years.
To provide the first 3-year longitudinal data regarding the clinical performance of RealTime, the risk of CIN2+ according to various negative baseline characteristics, and baseline and future risk for CIN2+ at 3 years for women with baseline infection with various hrHPV types were assessed in a cohort of 3,920 Slovenian women that had hrHPV DNA and/or cytology in 36- to 48-month follow-up results after a baseline screening round in 2009/2010.
A total of 36 CIN2+ cases were identified in the second screening round. Of these, 17 CIN2+ cases were identified passively through questionnaires/data registries and 19 cases actively as the result of actions triggered by second-round cytology and/or HPV test results. Accumulation of CIN2+ cases during follow-up occurred predominantly in woman with normal cytology at baseline. Among women >30 years old, significantly better protection against CIN2+ at 3 years was associated with a negative hrHPV DNA result at baseline (risk for CIN2+ 0.04% [95 CI, 0.00-0.22%]) than by normal cytology at baseline (risk for CIN2+ 0.68% [95 CI, 0.40-1.08%]). Women with baseline HPV16 infection had a significantly higher risk of CIN2+ at baseline (21.9% [95 CI, 15.2-30.4%]) and baseline plus future risk at 3 years for CIN2+ (33.3% [95 CI, 24.7-44.0%]) in comparison to women with baseline non-HPV16/18 hrHPV infection (7.0% [95 CI, 4.6-10.2%]) or those that were hrHPV-positive (11.7% [95 CI, 9.1-14.9%]).
3-year longitudinal data reinforce evidence from previous studies that RealTime can be safely used in primary HPV-based cervical cancer screening. Concurrent partial genotyping for HPV16/18 should be strongly considered as a triage method for HPV screen-positive women.
Poljak M
，Oštrbenk A
，Seme K
，Šterbenc A
，Jančar N
，Vrtačnik Bokal E
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Evidence regarding human papillomavirus testing in secondary prevention of cervical cancer.
More than ever, clinicians need regularly updated reviews given the continuously increasing amount of new information regarding innovative cervical cancer prevention methods. A summary is given from recent meta-analyses and systematic reviews on 3 possible clinical applications of human papillomavirus (HPV) testing: triage of women with equivocal or low-grade cytologic abnormalities; prediction of the therapeutic outcome after treatment of cervical intraepithelial neoplasia (CIN) lesions, and last not but not least, primary screening for cervical cancer and pre-cancer. Consistent evidence is available indicating that HPV-triage with the Hybrid Capture(®) 2 assay (Qiagen Gaithersburg, Inc., MD, USA [previously Digene Corp.] (HC2) is more accurate (higher sensitivity, similar specificity) than repeat cytology to triage women with equivocal Pap smear results. Several other tests show at least similar accuracy but mRNA testing with the APTIMA(®) (Gen-Probe Inc., San Diego, CA, USA) test is similarly sensitive but more specific compared to HC2. In triage of low-grade squamous intraepithelial lesions (LSIL), HC2 is more sensitive but its specificity is substantially lower compared to repeat cytology. The APTIMA(®) test is more specific than HC2 without showing a loss in sensitivity. Identification of DNA of HPV types 16 and/or 18, or RNA from the five most carcinogenic HPV types allow selecting women at highest risk for CIN3+ but the sensitivity and negative predictive value of these markers are lower than full-range high-risk HPV (hrHPV) testing. After conservative treatment of cervical pre-cancer, HPV testing picks up more quickly, with higher sensitivity and not lower specificity, residual or recurrent high-grade CIN than follow-up cytology. Primary screening for hrHPV generally detects more CIN2, CIN3 or cancer compared to cytology at cut-off atypical squamous cells of undetermined significance (ASC-US) or LSIL, but is less specific. Combined HPV and cytology screening provides a further small gain in sensitivity at the expense of a considerable loss in specificity if positive by either test is referred to colposcopy, in comparison with HPV testing only. Randomised trials and follow-up of cohort studies consistently demonstrate a significantly lower cumulative incidence of CIN3+ and even of cancer, in women aged 30 years or older, who were at enrollment hrHPV DNA negative compared to those who were cytologically negative. The difference in cumulative risk of CIN3+ or cancer for double negative (cytology & HPV) versus only HPV-negative women is small. HC2, GP5+/6+ PCR (polymerase chain reaction), cobas(®) 4800 PCR (Roche Molecular Systems Inc., Alameda, CA, USA) and Real Time PCR (Abbott Molecular, Des Plaines, IL, USA) can be considered as clinically validated for use in primary screening. The loss in specificity associated with primary HPV-based screening can be compensated by appropriate algorithms involving reflex cytology and/or HPV genotyping for HPV16 or 18. There exists a substantial evidence base to support that HPV testing is advantageous both in triage of women with equivocal abnormal cytology, in surveillance after treatment of CIN lesions and in primary screening of women aged 30 years or older. However, the possible advantages offered by HPV-based screening require a well organised program with good compliance with screening and triage policies. This article forms part of a special supplement entitled "Comprehensive Control of HPV Infections and Related Diseases" Vaccine Volume 30, Supplement 5, 2012.
Arbyn M
，Ronco G
，Anttila A
，Meijer CJ
，Poljak M
，Ogilvie G
，Koliopoulos G
，Naucler P
，Sankaranarayanan R
，Peto J
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