高危型人乳头瘤病毒检测对宫颈上皮内瘤样病变诊断价值的探讨

目的:探讨在ASC-H患者中检测HR-HPV DNA预测宫颈上皮内瘤样病变(CIN)和浸润癌的价值,为完善CIN和浸润癌的筛查方案提供依据.方法:研究宫颈薄层液基细胞学诊断为ASC-H的患者68例,均进行HR-HPV DNA检测并在阴道镜下行宫颈组织活检,综合评价HR-HPV预测高级别CIN的价值.结果:在ASC-H中CIN发生率为52.9％(36/68),CINⅡ及以上病变(CINⅡ、CINⅢ及浸润癌)发生率为33.8％(23/68); HR-HPV检测阳性率为70.6％(48/68),HR-HPV阳性组CINⅡ及以上病变发生率为47.9％(23/48),HR-HPV阴性组CINⅡ及以上病变发生率为0(0/20),两组比较差异有统计学意义,x2=14.797,P=0.001,HR-HPV诊断CINⅡ及以上病变的敏感度和特异度分别为100.0％和44.4％,阳性预测价值和阴性预测价值分别为47.9％和100.0％.结论:初步研究结果提示,HR-HPV阳性ASC-H患者应高度警惕CINⅡ及以上病变发生,建议立即行阴道镜检查;而HR-HPV阴性患者可不进行阴道镜检查.     

阴道滴虫与宫颈HR-HPV 感染及宫颈癌发生的相关性

 目的 探讨阴道滴虫是否能增加高危人乳头瘤病毒（HR-HPV）感染和宫颈癌发生的危险。方法 对受检者进行液基细胞学检查和HR-HPV DNA检测，并在细胞学诊断中记录是否存在滴虫。对所有细胞学诊断非典型鳞状细胞（ASC）及以上病变、HR-HPV DNA阳性病例和部分细胞学阴性及HR-HPV DNA阴性病例进行阴道镜检查及活检。分别比较滴虫在HR-HPV DNA阳性组和阴性组、细胞学及组织学各级诊断中的存在率。结果 在13024例受检者中有1687例（12．95％）涂片中有滴虫。滴虫存在率在HR-HPV DNA阳性组与阴性组中无显著统计学差异（P〉0．05），在细胞学阴性病例组显著高于鳞状上皮内病变组（P〈0．05），在组织学阴性病例组显著高于在≥CIN2病例组（P〈0．05）。结论 滴虫的存在不增加HR-HPV感染率，也不增加宫颈癌发生的危险。     

阴道镜筛查细胞学阴性的光滑宫颈上皮内瘤变的临床意义

目的 探讨阴道镜筛查常规妇科检查宫颈光滑、细胞学阴性病例宫颈上皮内瘤变（CIN）的临床意义。方法 对门诊就诊或健康体检中妇科检查肉眼观察宫颈光滑、细胞学检查阴性的女性1050例进行阴道镜检查;对醋酸白色上皮和碘不着色异常征象及其他可疑病变进行活检组织病理检查。结果 （1）1050例中有458例进行了活检,另有56例同时取阴道镜下可疑病变部位和宫颈口息肉／息肉样赘生物部位进行活检,检出CIN 68例,其中属高危病变CINⅡ／CINⅢ 11例;（2）1050例中有72例同时表现醋酸白色上皮和碘不着色双异常,其中64例活检证实为CIN,醋酸和碘双染色试验异常对CIN的阳性预测值88.9％,漏诊率为3.3％;（3）宫颈息肉或息肉样赘生物局部取材350例,仅检出1例CIN（0.3％）;阴道镜下异常病变部位取材164例,检出CIN 67例（40.9％）,其中CINⅡ／CINⅢ 11例（6.7％）;（4）对164例阴道镜下可疑病变病例年龄分布分析显示,醋酸白色上皮和碘不着色双异常在性活跃期年龄段分布频率较高,与CIN的年龄分布相一致,而单纯碘不着色呈现随年龄增大而出现频率增高的特点。结论 阴道镜下检查异常,尤其是醋酸白色上皮和碘不着色双异常,对筛查宫颈癌前病变CIN有积极意义,即使在细胞学检查阴性的光滑宫颈也有一定的必要性。     

HPV-DNA检测在宫颈病变诊断中的价值

背景与目的：宫颈癌是妇女常见的恶性肿瘤之一。目前大量的研究认为HPV是宫颈癌的主要致病因素，几乎所有CIN都伴有HPV亚型。本研究旨在评价HPV—DNA检测对宫颈病变的诊断价值。方法：对320例HPV—DNA检测患者在宫颈病变检查方面的资料进行分析。结果：①HPV—DNA高危型阳性患者无明显临床症状，妇科检查以宫颈糜烂为主要表现，②CIN发病率在HPV—DNA高危型阳性组30％，阴性组11％（P〈0．01），③HPV—DNA高危型阳性的CIN患者中17％是高度病变（CIN—Ⅱ及以上），阴性组仅2％（P〈0．05）④随细胞学检查的级别增高，HPV—DNA高危型阳性率增加（P〈0．05），HPV感染发生率增加（P〈0．01），CIN发生率增加（P〈0．05）。结论：HP—DNA高危型患者CIN发病率较高，CIN高度病变比例较高，HPV-DNA检测在宫颈病变的检查中有重要意义；如与宫颈细胞学检查和阴道镜检查结合可提高宫颈病变的检出率。     

联合检测在门诊宫颈癌筛查中的应用价值

目的探讨联合检测方法在门诊妇女宫颈癌筛查中的临床意义及应用价值。方法选择2010年至2012年在宫颈门诊进行宫颈癌筛查的812例妇女作为研究对象,首先进行液基细胞学（TCT）、HPV—DNA及肉眼观察3种检查;3种方法检测阳性者再分别进行阴道镜检查,金标准为病理组织学结果。结果TCT的敏感度、特异度、阳性预测值及阴性预测值分别为：75．0％、97．2％、35．3％和99．5％;HPV—DNA检查的敏感度、特异度、阳性预测值及阴性预测值分别为：81．3％、77．2％、6．7％和99．5％;肉眼观察的敏感度、特异度、阳性预测值及阴性预测值分别为：75．O％、84．5％、8．9％和99．4％。结论TCT联合阴道镜的诊断价值优于其余两种方法,可作医院门诊宫颈癌筛查的首选方法;HPV—DNA和肉眼观察联合阴道镜的诊断价值相当,但是肉眼观察法更经济,可作为经济条件差的妇女首选筛查方法。     

液基薄层细胞学检测在宫颈病变中的诊断价值

目的探讨液基薄层细胞学检测技术（TCT）对宫颈病变的诊断价值。方法对2008年12月到2011年12月1576例宫颈病变患者进行液基薄层细胞学检测,予以Betheasda系统（TBS）细胞学分类,阳性报告者行阴道镜检查及宫颈活组织检查,并对结果进行分析。结果1576例中阳性报告278例（17．64％）,炎症及其他1298例（82．36％）。阳性报告者阴道镜检查及宫颈活组织检查183例,病理报告提示：慢性炎症及其他68例,宫颈上皮内瘤变Ⅰ级（CINI）65例,宫颈上皮内瘤变Ⅱ级（CINⅡ）30例,宫颈上皮内瘤变Ⅲ级（CIN111）15例,宫颈鳞状细胞癌（SCC）5例。结论TCT检查结合阴道镜检查及宫颈活组织检查能提高宫颈癌前病变及宫颈癌的检出率,其诊断结果与病理学诊断符合率高,是宫颈病变筛查的有效方法。     

液基超薄细胞技术及TBS系统用于宫颈癌及癌前病变筛查

[目的]探讨液基超薄细胞技术（TCT）和Bethesda系统（TBS）在宫颈癌及癌前病变筛查中的临床应用价值。[方法]1100例患者行TCT检查和TBS细胞学分类诊断，阳性诊断包括意义不明的不典型鳞状细胞（ASCUS）。所有ASCUS以上病变的受检者全部在阴道镜下活检。[结果]1100例患者巾ASCUS32例、不除外高度病变的不典型鳞状上皮（ASC—H）18例、低度鳞状上皮内病变（LSTL）26例、高度鳞状上皮内病变（HSIL）16例、鳞状细胞癌2例。阴道镜下活检结果：CINⅠ26例、CINⅡ13例、CINⅢ9例、宫颈鳞癌3例，阴道镜病理检查符合率为71．28％。[结论]TCT技术应用于宫颈涂片细胞学检查，配合阴道镜下活检是筛查和诊断宫颈痛硬痛前病弯的可靠手段。     

p16INK4a免疫细胞化学检测在筛查宫颈癌中的作用

目的 探讨p16^INK4a免疫细胞化学检测在筛查宫颈癌及其癌前病变中的作用。方法 选择220例宫颈液基细胞学剩余标本,制作液基薄片进行p16^INK4a 免疫细胞化学检测,随访组织活检结果,并与高危人乳头瘤病毒（HR—HPV）DNA检测结果进行对照。结果 p16^INK4a在宫颈细胞学诊断的鳞状细胞癌（SCC）、鳞状上皮内高度病变（HSIL）、鳞状上皮内低度病变（LSIL）、非典型鳞状细胞-小除外上皮内高度病变（ASC—H）和非典型鳞状细胞-不能明确意义（ASC—US）病例的阳性表达率分别为100．0％（7／7）、92．2％（107／116）、24．3％（17／70）、100．0％（14／14）和36．4％（4／11）。150例p16^INK4a阳性者中,111例有组织活检诊断,其中宫颈上皮内瘤变（CIN）2级及以上病变者97例（87．4％）;70例p16^INK4a阴性者中,18例有组织活检诊断,无一例CIN2及以上病变。p16^INK4a在CIN2及以上病变与在CIN1之间的阳性表达率差异有统计学意义（P〈0.01）,而HR-HPV DNA的阳性率在两者之间差异无统计学意义。结论 p16^INK4a在宫颈HSIL及以上病变中高表达,有利于高危病例的筛选。     

宫颈癌早诊早治农村示范基地研究报告

[目的]通过对9176名妇女采用醋酸或碘染色肉眼筛查方法（VIA/VILI）筛查宫颈癌的早诊早治结果分析,评价在农村高发区宫颈癌采用该筛查方式推广应用的可行性。[方法]以山西省襄垣县30～59岁的妇女作为研究对象进行以自然人群为基础的宫颈癌筛查,用醋酸染色后肉眼观察（VIA）和碘染色后肉眼观察（VILI）进行宫颈检查,VIA或VILI阳性者进行阴道镜检查,阴道镜异常者在病变处取活检进行病理学诊断。采用同样方法对该人群连续复查两年。[结果]首次筛查人群参与率为73.92%,二次复查率为84.3%。2005年首次筛查了1287例妇女,最终经病理确诊的CINⅠ10例、CINⅡ9例、CINⅢ13例、宫颈癌3例。该方法与已往该地区采用液基细胞学和HPV检测联合筛查方法相比较,CINⅡ和≥CINⅢ病变的检出率略低,但差异无统计学意义。连续两年复查出5例CINⅠ,3例CINⅡ,1例CINⅢ。2006～2008年共筛查7889例,首次筛查最终病理确诊116例CINⅠ,36例CINⅡ,35例CINⅢ,4例早期浸润癌,浸润性鳞癌5例。第二次复查,经病理确诊75例CINⅠ,24例CINⅡ,15例CINⅢ,1例早期浸润癌。[结论]在资源有限．经济不发达的农村地区．用VIA／VILI方法对宫颈癌及其癌前病变的筛查是可行的．建议进一步在农村地区进行推广。     

细胞DNA倍体图像分析在宫颈癌及癌前病变筛查中的应用

目的利用显微图像分析技术对宫颈脱落细胞做DNA倍体检测、分析,以探讨该技术在宫颈癌及癌前病变筛查中的应用价值。方法对619例宫颈脱落细胞样本分别采用常规细胞学镜检和细胞DNA倍体分析法作检测,其中阳性样本患者行组织活检,并将3种检测结果进行对比分析。结果619例样本,常规细胞学镜检共检出ASC—US42例、ASC—H6例、LSIL29例、HSILl8例;采用细胞倍体分析法检出DI≥2．5时,可见DNA倍体异常细胞（1～2个）的样本102例、DNA倍体异常细胞（≥3个）的样本41例、DNA倍体异常细胞（≥25个）的样本14例;48例组织活检样本检出炎症7例、CINI20例,CINⅡ13例、CINⅢ2例、IC6例。CINⅡ～Ⅲ对应TBS系统中的HSIL计算灵敏度为81．0％;对应SIL和对应ASC＋SIL的灵敏度分别为85．7％和100％。HSIL与CINⅡ～Ⅲ比较有非常显著的统计学意义。CINⅡ～Ⅲ对应DNA倍体异常细胞（≥25个）计算灵敏度为66．7％;对应可见DNA倍体异常细胞（≥3个）的灵敏度为100％。DNA倍体异常细胞（≥25个）与CINⅡ～Ⅲ比较也有非常显著的统计学意义。结论细胞DNA倍体图像分析法在宫颈癌及癌前病变筛查中有较高的灵敏度,若联合常规宫颈细胞学检查,可明显提高宫颈癌筛查的质量控制水平。     

轻度宫颈上皮内瘤变自然转归的前瞻性研究

[目的]研究轻度宫颈上皮内瘤变（CINⅠ）的自然转归、人乳头瘤病毒（HPV）的自然清除率及两者之间的关系。[方法]对2003年5月到2006年4月期间,在北京大学深圳医院经阴道镜下活检病理诊断为CINⅠ的548名患者,定期随访4～6年。以宫颈液基细胞学检查（LCT）联合高危型HPV（HR-HPV）DNA检测（HC-Ⅱ）作为随访的监测方法,每6～12月随访一次。对于随访中细胞学为未明确诊断意义的不典型鳞状上皮细胞（ASCUS）及以上病变,及/或HR-HPV阳性者行阴道镜下多点活检,病理诊断。[结果]随访48个月时共失访27人,剔除34人,继续随访487人,累积未完全随访率为11.13%。随访6个月、12个月、24个月、36个月、48个月时进展为高度宫颈上皮内瘤变的百分率分别为0.55%、1.65%、3.10%、4.05%、4.11%;病变持续存在的百分率分别为70.25%、45.77%、23.79%、11.54%、7.19%;病变逆转为正常的百分率分别为29.20%、52.57%、73.11%、84.41%、88.71%。随访48个月时,35岁以上组和35岁以下组的病变进展率和逆转率均无显著性差异。随访开始时HR-HPV阳性的患者462例,随访6个月、12个月、24个月、36个月、48个月时病毒自然清除率分别为24.26%、48.69%、70.05%、81.54%、86.36%,HPV清除与CINⅠ病变逆转趋势一致。24个月内HPV持续阳性的患者,在48个月内进展为高度宫颈上皮内瘤变的比率为18.9%,显著高于HPV阴转组和HPV持续阴性组。[结论]2年内超过2/3的CINⅠ病变会自然逆转,HPV也会自然清除,但对于HPV持续阳性的患者应警惕其进展为高度宫颈上皮内瘤变。     

Value of CCNA1 promoter methylation in triaging ASC-US cytology

Background: Using HPV testing to triage ASC-US still has some problems of unnecessary colposcopy in many cases. A previous study reported that methylation of CCNA1, a tumor suppressor gene, can differentiate between low and high grade lesions.  This study was designed to evaluate the diagnostic values and application of CCNA1 methylation in the patients with ASC-US group. Materials and Methods: Cross sectional analytic study was conducted in the patients with ASC-US cytology. HPV DNA testing and CCNA1 promoter methylation testing were performed.  The patients were sent for colposcopic examination and biopsy. Biopsy results were considered as gold standard.  Diagnostic test of HPV test and CCNA1 methylation test were calculated for sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), likelihood ratio for test positive and negative and 95% confidence interval. Results: One hundred and seventy patients were enrolled. Mean age was 39.7 years old.  HR-HPV was positive in 70% of the patients.  HPV type 16, type 18 and non-16,18 were 12.4%, 4.7% and 42.4%, respectively. CIN2+ were found in 12.4% (21 cases). CCNA1 promoter methylation was positive in 5 cases.  CCNA1 had high specificity 99.3%, NPV 89.2% and PPV 80% in detection of CIN2+ but sensitivity was 19%. Likelihood ratio for positive test was 28.4 and likelihood ratio for negative test was 0.8.  HPV test had sensitivity of 90.5% and NPV of 95.9% but low specificity and PPV as 31.5% and 15.7%, respectively. Conclusion: CCNA1 promoter methylation testing had very high specificity, likelihood ratio for the positive test and PPV (99.3%, 28.4 and 80.0, respectively).  Therefore, CCNA1 promoter methylation test may be used in the HPV DNA positive cases to classify the urgency of colposcopy and the colposcopist should pay more attention to CCNA1 positive patients because of their higher chance to identify the significant lesions.     

Risk assessment to guide cervical screening strategies in a large Chinese population

Three different cervical screening methods [cytology, human papillomavirus(HPV) testing and visual inspection with acetic acid(VIA)] are being considered in China for the national cervical screening program. Comparing risks of CIN3 and cervical cancer (CIN3+) for different results can inform test choice and management guidelines. We evaluated the immediate risk of CIN3+ for different screening results generated from individual and combined tests. We compared tests using a novel statistic designed for this purpose called Mean Risk Stratification (MRS), in a pooled analysis of 17 cross sectional population‐based studies of 30,371Chinese women screened with all 3 methods and diagnosed by colposcopically‐directed biopsies. The 3 tests combined powerfully distinguished CIN3+ risk; triple‐negative screening conferred a risk of 0.01%, while HPV‐positive HSIL+ that was VIA‐positive yielded a risk of 57.8%. Among the three screening tests, HPV status most strongly stratified CIN3+ risk. Among HPV‐positive women, cytology was the more useful second test. In HPV‐negative women, the immediate risks of CIN3+ ranged from 0.01% (negative cytology), 0.00% (ASC‐US), 1.1% (LSIL), to 6.6 (HSIL+). In HPV‐positive women, the CIN3+ risks were 0.9% (negative cytology), 3.6% (ASC‐US), 6.3% (LSIL) and 38.5% (HSIL+). VIA results did not meaningful stratify CIN3+ risk among HPV‐negative women with negative or ASC‐US cytology; however, positive VIA substantially elevated CIN3+ risk for all other, more positive combinations of HPV and cytology compared with a negative VIA. Because all 3 screening tests had independent value in defining risk of CIN3+, different combinations can be optimized as pragmatic strategies in different resource settings.     

Should women with atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion, receive reflex human papillomavirus-DNA testing?

BACKGROUND: The 2001 American Society for Colposcopy and Cervical Pathology Consensus Guidelines recommend that women who have Papanicolaou (Pap) smears diagnosed as atypical squamous cells (ASC), cannot exclude high-grade squamous intraepithelial lesion (HSIL) (ASC-H) should be referred for immediate colposcopic examination. The objective of this pilot study was to evaluate whether reflex human papillomavirus (HPV)-DNA testing performed on smears diagnosed as ASC-H may obviate the need for immediate colposcopic examination. METHODS: All ThinPrep Pap smears that were diagnosed as ASC-H or atypical squamous metaplastic cells (ASMT) between 2001-2003 and that had HPV-DNA testing and subsequent histologic and/or cytologic follow-up were evaluated. Those smears that were diagnosed as ASMT were reviewed and reclassified under the 2001 Bethesda System as either ASC of undetermined significance (ASCUS) or ASC-H. Smears that were diagnosed as ASCUS were excluded from the study. RESULTS: The study included of 48 smears that were diagnosed as ASC-H. All patients with biopsy-proven HSIL had positive high-risk (HR)-HPV results (100% negative predictive value). Approximately 80% of patients with ASC-H who had biopsy-proven, low-grade intraepithelial lesion on follow-up had positive HR-HPV results. Among the patients who had ASC-H with negative follow-up, 50% had positive HR-HPV results, and 50% had negative HR-HPV results. CONCLUSIONS: Among patients with ASC-H, a negative HR-HPV result was found to be an excellent predictor of the absence of HSIL. The results of this pilot study suggested that HPV-DNA testing may serve as a means to better select which patients with ASC-H on Pap smear should undergo colposcopic examination. This approach potentially may reduce medical costs and eliminate the need for routine colposcopic examination among patients with ASC-H Pap smears.     

Prevalence of human papillomavirus and cervical intraepithelial neoplasia in China: A pooled analysis of 17 population-based studies

High-risk (HR) human papillomavirus (HPV) prevalence has been shown to correlate well with cervical cancer incidence rates. Our study aimed to estimate the prevalence of HR-HPV and cervical intraepithelial neoplasia (CIN) in China and indirectly informs on the cervical cancer burden in the country. A total of 30,207 women from 17 population-based studies throughout China were included. All women received HPV DNA testing (HC2, Qiagen, Gaithersburg, MD), visual inspection with acetic acid and liquid-based cytology. Women positive for any test received colposcopy-directed or four-quadrant biopsies. A total of 29,579 women had HR-HPV testing results, of whom 28,761 had biopsy confirmed (9,019, 31.4%) or assumed (19,742, 68.6%) final diagnosis. Overall crude HR-HPV prevalence was 17.7%. HR-HPV prevalence was similar in rural and urban areas but showed dips in different age groups: at age 25–29 (11.3%) in rural and at age 35–39 (11.3%) in urban women. In rural and urban women, age-standardized CIN2 prevalence was 1.5% [95% confidence interval (CI): 1.4–1.6%] and 0.7% (95% CI: 0.7–0.8%) and CIN3+ prevalence was 1.2% (95% CI: 1.2–1.3%) and 0.6% (95% CI: 0.5–0.7%), respectively. Prevalence of CIN3+ as a percentage of either all women or HR-HPV-positive women steadily increased with age, peaking in 45- to 49-year-old women. High prevalence of HR-HPV and CIN3+ was detected in both rural and urban China. The steady rise of CIN3+ up to the age group of 45–49 is attributable to lack of lesion removal through screening. Our findings document the inadequacy of current screening in China while indirectly raising the possibility that the cervical cancer burden in China is underreported.     

Silent High Grade Cervical Intraepithelial Neoplasia in Atypical Smears from Liquid Based Cervical Cytology - Three Years Experience in Thammasat University Hospital

Purpose: To study the prevalence of CIN2 diagnosis in women with atypical Papaniculoau (Pap) smears to suggest appropriate management option for Thai health care. Materials and Methods: Data from all patients with liquid based cytology with human papillomavirus (HPV) testing between May 2013 - May 2016 were collected from medical records. Women with atypical cervical Pap smears were recruited. Results for age, HPV testing, HPV 16, 18, 45 and other genotypes tested, colposcopic examination and histopathological assessment were all collected. Atypical smears were defined as atypical squamous cells of undetermined significance (ASC-US) and atypical squamous cells cannot be exclude high grade squamous intraepithelial lesion (ASC-H). Results: A total of 2,144 cases were recruited. Twenty six women with ASC-US on cytology had high risk (HR) HPV detection while eight cases with ASC-H had HR-HPV (40.0% VS 72.7%, p0.005). Among the 26 women with ASC-US cytology and positive HR-HPV, HPV type 16 (n8, 30.8%), type 18 (n1, 3.8%), type 45 (n1, 3.8%) and other HPV types (n17, 65.4%) were found. Eight women with ASC-H and positive HR-HPV demonstrated type 16 (n6, 75%) and other HPV types (n2, 25%). Fifty seven women with ASC-US had normal colposcopy, CIN1 and CIN2 at percentages of 80.7 (46/57), 14.0 (8/57) and 5.3 (3/57), respectively. In the ASC-H group, 7 out of 10 women had normal colposcopy and three (30%) had CIN2 results. Conclusions: In women with ASC-US cytology, immediate colposcopy is highly recommended. HPV testing can be performed if colposcopy is not an available option because there was high prevalence (5.3%) of CIN2 in our findings. ASCCP recommendations for ASC-H that colposcopy should be performed on all ASC-H cases regardless of HPV result are thereby supported by the findings of this investigation.     

Contribution of DNA ploidy image cytometry to the management of ASC cervical lesions

BACKGROUND: The Bethesda system classifies smears that suggest an underlying cervical intraepithelial neoplasia (CIN) as ASC (atypical squamous cell) smears. ASC smears are subdivided into ASCUS (of undetermined significance) and ASCH (cannot exclude a high-grade lesion). Today the management of ASCUS is a triage with HR-HPV testing and colposcopy is recommended for ASCH. The aim was to conduct a study on ASC smears to determine DNA ploidy measurement for the detection of CIN2+. METHODS: The link between a suspect DNA ploidy assessed by image cytometry and/or a positive HR-HPV testing was analyzed on 69 ASCUS and 82 ASCH smears, and the presence of CIN2+ within 12 months after ASC diagnosis. The ploidy was suspect in case of aneuploidy, multiploidy, or in the presence of cells with a DNA content >5c or >9c. RESULTS: Every woman who had a CIN2+ had a suspect DNA profile in the ASCUS smears and every woman except 1 was HR-HPV-positive. The link between a positive HR-HPV test or a suspect DNA profile or both and a CIN2+ was high (P = .019, .023, and .008, respectively). The presence of >9c cells was particularly linked to CIN2+ (P = .0031). In all, 90.9% and 87.9% of the ASCH smears with CIN2+ were, respectively, HR-HPV positive or had a suspect ploidy (P = .0000 and P = .0043), and the presence of >9c cells was also linked to CIN2+ (P = .003). CONCLUSIONS: HR-HPV testing and determination of the ploidy profile with special attention to 9c-exceeding cells could be accurate for a better management of ASC smears.     

Lower cost strategies for triage of human papillomavirus DNA‐positive women

Using human papillomavirus (HPV) testing for cervical cancer screening in lower‐resource settings (LRS) will result in a significant number of screen‐positive women. This analysis compares different triage strategies for detecting cervical precancer and cancer among HPV‐positive women in LRS. This was a population‐based study of women aged 25–65 years living in China (n = 7,541). Each woman provided a self‐collected and two clinician‐collected specimens. The self‐collected and one clinician‐collected specimen were tested by two HPV DNA tests—careHPV? and Hybrid Capture 2; the other clinician‐collected specimen was tested for HPV16/18/45 E6 protein. CareHPV?‐positive specimens were tested for HPV16/18/45 DNA. HPV DNA‐positive women underwent visual inspection with acetic acid (VIA) and then colposcopic evaluation with biopsies. The performance for detection of cervical intraepithelial neoplasia grade 3 or cancer (CIN3+) among HPV DNA‐positive women was assessed for different triage strategies: HPV16/18/45 E6 or DNA detection, VIA, colposcopic impression, or higher signal strength (≥10 relative light units/positive control [rlu/pc]). The percent triage positive ranges were 14.8–17.4% for VIA, 17.8–20.9% for an abnormal colposcopic impression; 7.9–10.5% for HPV16/18/45 E6; 23.4–28.4% for HPV16/18/45 DNA; and 48.0–62.6% for higher signal strength (≥10 rlu/pc), depending on the HPV test/specimen combination. The positivity for all triage tests increased with severity of diagnosis. HPV16/18/45 DNA detection was approximately 70% sensitive and had positive predictive values (PPV) of approximately 25% for CIN3+. HPV16/18/45 E6 detection was approximately 50% sensitive with a PPV of nearly 50% for CIN3+. Different triage strategies for HPV DNA‐positive women provide important tradeoffs in colposcopy or treatment referral percentages and sensitivity for prevalent CIN3+.