Commercially available assays for multiplex detection of alpha human papillomaviruses

Five main groups of commercial assays for the multiplex detection of alpha human papillomaviruses (HPVs) are currently available. DNA-based screening assays, which test for the presence of 13-14 HPVs without determination of HPV type, have been the standard for HPV detection in the last decade. Assays that combine testing for 14 HPVs and HPV-16 and HPV-18 genotyping are a potential future standard for HPV detection. The clinical value of HPV genotyping assays has still not been finally determined. Recently, one of the mRNA-based assays showed equal clinical sensitivity but higher clinical specificity for CIN2+/CIN3+ in comparison with the validated DNA-based assay. In situ hybridization assays are too laborious and have insufficient clinical sensitivity to be used in routine screening. Automation, price reduction and improvement of clinical specificity are the main goals for the future development of HPV assays.     

液基细胞学技术与HPV导流杂交在筛查宫颈癌中的应用价值

目的探讨液基细胞学技术(TCT)与人乳头状病毒(HPV)检测对筛查宫颈癌的临床价值。方法对妇科门诊患者分别做TCT检查或HPV导流杂交反斑点印迹(Reverse dot blot,RDB)快速基因分型检测及宫颈活检,并对进行TCT和HPV检测的患者进行统计分析。结果 TCT检查对活检诊断≥宫颈上皮内瘤变Ⅰ级(CINⅠ)宫颈病变的敏感度为58.39%,特异度65.36%,高危型HPV-DNA检测分别为72.34%和57.63%,高危型HPV-DNA检测敏感度较TCT检查高,而TCT检查特异度高于高危型HPV-DNA检测(P均0.01)。结论 TCT检查和HPV导流杂交快速基因分型检测方法在宫颈癌及癌前病变筛查中的联合应用,提高了宫颈癌和癌前病变的灵敏度和特异性,明显提高了宫颈癌筛查的检出率。     

Profile of the BD HPV OnclarityTM assay

Introduction: Validated molecular assays for the detection of high risk (hr) Human Papillomavirus (HPV) DNA underpin the screening protocols against cervical cancer. New molecular assays based on real-time PCR also display the genotype of hrHPV.

Areas covered: Recently, the BD Onclarity? HPV assay (Onclarity), extended HPV genotyping test, for use on the BD Viper? LT Instrument, has been developed. Onclaritys application for the detection and genotyping of hrHPV has been validated for the identification of women at high risk for cervical intraepithelial neoplasia of grade 2 or more in accordance with European Guidelines and FDA specifications.

Expert opinion: Onclarity displays good sensitivity and specificity performance for HR-HPV detection and offers the possibility for genotype-specific reporting: the latter could provide risk-stratification for high-grade cervical disease during screening and facilitate surveillance for persistent genotypes in women at follow-up visits.     

Efficiency of MY09/11 consensus PCR in the detection of multiple HPV infections

Human papillomavirus (HPV) DNA testing has become an important component of cervical cancer screening programs. In this study, we aimed to evaluate the efficiency of MY09/11 consensus polymerase chain reaction (PCR) for the detection of multiple HPV infections. For this purpose, MY09/11 PCR was compared to an original TaqMan-based type-specific real-time PCR assay, which can detect 20 different HPV types. Of the 654 samples, 34.1% (223/654) were HPV DNA positive according to at least one method. The relative sensitivities of MY09/11 PCR and type-specific PCR were 80.7% (180/223) and 97.8% (218/223), respectively. In all, 352 different HPV isolates (66 low-risk and 286 high-risk or probable high-risk types) were identified in 218 samples, but 5 samples, which were positive by consensus PCR only, could not be genotyped. The distribution of the 286 high-risk or probable high-risk HPVs were as follows: 24.5% HPV-16, 8.4% HPV-52, 7.7% HPV-51, 6.3% HPV-39, 6.3% HPV-82, 5.6% HPV-35, 5.6% HPV-58, 5.6% HPV-66, 5.2% HPV-18, 5.2% HPV-68, and 19.6% the other 8 types. A single HPV type was detected in 57.3% (125/218) of the genotyped samples, and multiple HPV types were found in the remaining 42.7% (93/218). The false-negative rates of MY09/11 PCR were found to be 17.4% in single infections, 23.3% in multiple infections, and 34.6% in multiple infections that contained 3 or more HPV types, with the condition that the low-risk types HPV-6 and HPV-11 be considered as a monotype. These data suggest that broad-range PCR assays may lead to significant data loss and that type-specific PCR assays can provide accurate and reliable results during cervical cancer screening.     

A comparison study of human papillomavirus prevalence by the polymerase chain reaction in low risk women and in a gynaecology referral group at elevated risk for cervical cancer.

The reported prevalence of human papillomavirus (HPV) type 16 in the genital tracts of women with various gynaecological conditions is highly variable. In particular, some results with the polymerase chain reaction (PCR) technique have suggested that HPV-16 is a ubiquitous or very common virus. We undertook this study to help clarify the current confusion. PCR with HPV consensus L1 primers and specific E6 primers was used to study 89 women attending two gynaecology referral clinics, as well as 99 women attending a health maintenance organization (HMO) clinic; 70 of these latter women had no current or prior history of genital HPV disease. HPV-16 was detected in less than 5% of cytologically normal women from either group and in 17% (6/36) and 31% (9/29) of women with cervical intraepithelial neoplasia (CIN) from the referral clinic and the HMO, respectively. The other high-risk or intermediate-risk HPVs (types 18, 31, 33 or 35) were less prevalent than HPV 16 in all groups of women. A majority of the HPV types detected by the L1 primers in normal women were uncharacterized HPVs. Overall these uncharacterized HPVs were detected in 37% (46/123) of the normal women and in 48% (31/65) of the women with CIN. Using the most sensitive PCR product detection method employed in the study, HPV DNA was detected in 36% (4/11) of swab specimens obtained from the external abdomen.     

人乳头瘤病毒E6／E7mRNA检测在宫颈病变筛查中的应用价值

目的：探讨人乳头瘤病毒（HPV）E6/E7 mRNA 检测在宫颈病变筛查中的应用价值。方法2012年6月至2013年4月在余姚市人民医院因宫颈炎症、阴道异常出血或排液的720例门诊患者行宫颈 TCT 和 HPV DNA 检测,对 TCT 结果≥ASC-US 或（和）高危 HPV DNA 阳性者行宫颈 HPV E6/E7mRNA 检测和组织病理学检查。以病理学结果为标准,与 HPV DNA 检测相比较,评价 HPV E6/E7 mRNA 检测对 CIN2＋诊断价值,并用受试者工作特征（ROC）曲线评价其准确性。结果在 CIN 和宫颈浸润癌中,HPV E6/E7 mRNA 总体阳性率为78．7％,低于 HPV DNA 总体阳性率（92．6％）,差异有统计学意义（P ＜0．001）。HPV E6/E7 mRNA 检测诊断 CIN2＋的灵敏度为83．0％,低于 HPV DNA（94．5％）,差异有统计学意义（P ＜0．01）;特异度为51．1％,高于 HPV DNA（22．8％）,差异有统计学意义（P ＜0．001）。 HPV E6/E7 mRNA、HPV DNA 对诊断 CIN2＋的 ROC 曲线下面积分别为0．670、0.587, HPV E6/E7 mRNA 检测对 CIN2＋的诊断的准确性高于 HPV DNA,差异有统计学意义（P ＜0．01）。结论 HPV E6/E7 mRNA 检测诊断 CIN2＋特异度和准确性高于 HPV DNA,对宫颈病变的筛查有一定应用价值。     

Consistency evaluation of Liferiver,Yaneng, Darui,and the Cobas 4800 test for high-risk human papillomavirus screening

BackgroundIn recent years, several high‐risk human papillomavirus (HR‐HPV) tests have been developed. The assay capabilities need to be systematically reviewed. Here, we compared the clinical sample performance of three novel HR‐HPV assays (Liferiver, Yaneng, and Darui) based on different platforms with the widely adopted cobas4800 test.MethodsA total of 346 cervical swabs from women who were screened for cervical cancer were analyzed for the presence of 14 HR‐HPV genotypes. The distinction between the four assays was investigated by the genotyping and direct sequencing.ResultsThe positive rates of the four assays ranged from 61.56% to 64.16%. The overall concordance was 88.15%. The Yaneng assays displayed the best sensitivity (100%) and specificity (98.43%). The sensitivity (98.17%) and specificity (98.43%) of the Darui assay were superior to those of the cobas4800 test (97.72% and 93.70%, respectively). The Liferiver assay displayed comparable sensitivity with the cobas4800 test (95.89% and 97.72%, respectively). The specificity of the cobas4800 was lower than that of the Liferiver assay (93.70% vs. 97.64%).ConclusionsThe three novel HR‐HPV assays displayed good agreement with the cobas4800 test. The analytical performance of all four fulfilled the requirements of sensitivity and specificity for HR‐HPV detection.     

Accuracy of genotyping for HPV16 and 18 to triage women with low-grade squamous intraepithelial lesions: a pooled analysis of VALGENT studies

Background: Genotyping for the most carcinogenic human papillomavirus (HPV) types (HPV16/HPV18) can identify high risk of underlying cervical precancer and guide further management.

Research design and methods: A pooled analysis was performed of the clinical accuracy of high-risk HPV (hrHPV) testing and HPV16/18 genotyping in triage of women with low-grade squamous intraepithelial lesions (LSIL). Data regarding 24 assays evaluated in four VALGENT validation panels were used.

Results: In women with LSIL, hrHPV had a pooled sensitivity for CIN2+ of 95.5% (95% CI: 91.0–97.8%) and a specificity of 25.3% (95% CI: 22.2–28.6%). HPV16/18 genotyping had a sensitivity and specificity for CIN2+ of 52.9% (95% CI: 48.4–57.4%) and 83.5% (95% CI: 79.9–86.5%), respectively. The average risk of CIN2+ was 46.1% when HPV16/18-positive, 15.5% in women who were HPV16/18-negative but positive for other hrHPV types and 4.3% for hrHPV-negative women.

Conclusions: Triage of women with LSIL with HPV16/18 genotyping increases the positive predictive value compared to hrHPV testing but at the expense of lower sensitivity. Arguably, women testing positive for HPV16/18 need further clinical work-up. Whether colposcopy referral or further surveillance is recommended for women with other hrHPV types may depend on the post-test risk of precancer and the local risk-based decision thresholds.     

延安地区妇女HPV基因分型及临床相关研究

目的 对比分析延安市妇女人乳头瘤病毒(HPV)感染的基因型分布情况和临床特点,为宫颈癌筛查和防治提供数据支持。方法 采用导流杂交法对HPV感染型别进行基因分型,统计临床感染分布数据,并对其结果进行对比分析。结果 2 014例妇女中共检出HPV阳性者332例,阳性率16.48%,HPV高危型中HPV-16,52和53居于前三位,HPV低危型以HPV-81,6和44为主。阳性标本中单纯高危型感染219例,单纯低危型感染74例,混合感染39例,构成比分别为65.96%,22.29%和11.75%。HPV感染率随年龄增长呈现先增长后下降的趋势,各组比较差异有统计学意义(χ²=34.238,P<0.01)。不同职业人群HPV阳性检出率不同,各组比较差异有统计学意义(χ²=50.35,P<0.01)。不同地域人群HPV阳性检出率也存在差异,各组比较差异有统计学意义(χ²=12.084,P<0.05)。HPV感染结果中单一感染占比最高。结论 HPV感染率在不同人群、地域、年龄存在差异,进行HPV筛查对于宫颈癌的早期预防和治疗具有重要的意义。     

Human papillomavirus E6/E7 mRNA testing as a predictive marker for cervical carcinoma

Human papillomavirus (HPV) is necessary for the development of cervical carcinoma, and incorporation of molecular testing for HPV in screening and patient management has been proposed. Sufficient scientific evidence exists to recommend HPV DNA testing in the triage of women with equivocal cytology and in follow-up after the treatment of precursor lesions. However, due to a low clinical specificity and positive predictive value, HPV DNA testing has so far not been recommended as primary screening in Europe. In general, diagnostic HPV tests have to demonstrate accuracy, reproducibility and clinical utility before they can be used in patient management and implemented in cervical cancer screening programmes. In this article we give an overview of RNA-based HPV diagnostics and the role of E6/E7 mRNA detection as a predictive marker for the development of cervical carcinoma. HPV E6/E7 mRNA testing for high-risk types seems to correlate better with the severity of the lesion compared with HPV DNA testing, and is a potential marker for the identification of women at risk of developing cervical carcinoma. Commercial assays for simultaneous genotyping and detection of E6/E7 mRNA from the five most common high-risk HPV types are now available and require further evaluation for primary screening, triage and follow-up after treatment.     

HPV-DNA与液基制片法在宫颈癌前病变检测中的临床价值研究

目的比较人乳头瘤病毒(HPV)-DNA检测法与液基制片细胞学检测法在宫颈癌前病变诊断中的临床价值。方法将200例新疆医科大学第二附属医院收集的宫颈病变患者作为研究对象,予以HPV-DNA法和液基制片法检测,比较HPV-DNA法和液基制片法在宫颈癌前病变检测中的准确性。结果采用HPV-DNA检测法的检测阳性率为7.5%,液基制片法为8.5%,两组之间比较差异无统计学意义(P0.05)。以宫颈上皮内瘤变(CIN)Ⅰ级为癌前病变的诊断标准,HPV-DNA检测法筛查宫颈癌前病变的符合率为80.0%,液基制片法为41.2%,两组之间比较差异有统计学意义(P0.05)。并且HPV-DNA检测法的灵敏度和特异度均高于液基制片法。受试者工作特征曲线(ROC)统计分析显示,HPV-DNA法、液基制片法和HPVDNA联合液基制片法这3种检测方法的曲线下面积(AUC)分别为0.761,0.715和0.867。结论 HPV-DNA联合液基制片法是宫颈癌前病变检测较为敏感和准确的方法。     

高危型人乳头状瘤病毒检测在宫颈癌筛查中的价值

目的评价人乳头状瘤病毒（HPV）DNA检测在宫颈癌筛查中的价值。方法采用第二代杂交捕获（HC-Ⅱ）技术和液基细胞学测试（LCT）2种方法 ,对1026例在妇科病中心就诊的受检者进行同步盲法检测,同时进行阴道镜检查。以宫颈活检组织病理学检查结果为诊断标准。评价该方案在宫颈癌筛查中的应用价值。结果病理检查结果显示,宫颈上皮内瘤变（CIN）-Ⅰ级152例,CIN-Ⅱ级108例,CIN-Ⅲ级109例,宫颈浸润癌28例。筛查高危型HPV感染366例,阳性率35.70%,在不同宫颈病变中的阳性率分别是：宫颈癌92.90%（26/28）,CIN-Ⅲ90.0%（99/109）,CIN-Ⅱ88.90%（96/108）,CIN-Ⅰ87.50%（133/152）。高危HPV对宫颈高级别病变的敏感性、特异性、阳性预测值,阴性预测值分别是98.60%、86.10%、14.80%和99.80%;HPV与LCT联合检测（平行试验）的以上各指标分别是100.00%、80.90%、12.10%和100.00%。结论高危型人乳头状瘤病毒检测在宫颈癌前病变的筛查中有较高的敏感度和阴性预测值,联合LCT检测是目前宫颈癌筛查具有诊断价值的方法 。     

线性阵列基因分型技术检测女性尿液中人类乳头瘤病毒

目的：检测尿液标本中人类乳头瘤病毒（HPV）,并与宫颈以及外阴标本进行比较,探讨其与宫颈疾病的相关性,从而为宫颈癌的筛查提供参考。方法收集患者新鲜尿液以及外阴和宫颈分泌物,采用基于 PCR 的线性阵列基因分型技术检测 HPV。同时计算3种标本中 HPV 检出率的一致性,并与临床细胞与组织学分型做比较。结果致癌性 HPV 在尿液和宫颈样本的一致性是80％（112/140）,尿液与外阴样本中的一致性为83．3％（110/132）,外阴和宫颈样本中的一致性为90．9％（120/132）。尿液中致癌性 HPV 的敏感性和特异性分别为81．8％（95％ CI＝69．4-92．2）和51．1％（95％ CI＝35．6-68．4）,宫颈标本中 HPV 敏感性和特异性分别为95．5％（95％ CI＝81．2-99．7）和40．4％（95％ CI＝24．7-56．2）,外阴分泌物中 HPV 敏感性和特异性分别为95．2％（95％ CI＝80．5-99．5）和40．5％（95％ CI＝25．5-57．5）。结论尿液致癌性 HPV 检出率较低,但与临床细胞与组织学检查具有较好的一致性。因此还有待增加样本含量以进一步评价其在宫颈癌筛查中的作用。     

Comparison of the performance of the NucliSENS EasyQ HPV E6/E7 mRNA assay and HPV DNA chip for testing squamous cell lesions of the uterine cervix

This study aims to evaluate the clinical performance of the NucliSENS EasyQ assay and compare it with HPV DNA genotyping for the detection of high-grade squamous intraepithelial lesions (HSIL) and cancer in a Korean population. In 188 total thin prep samples, the remaining fluid after cytology slide preparation was tested with Goodgene HPV DNA chips and the NucliSENS EasyQ HPV E6/E7 messenger RNA (mRNA) assay. The sensitivity and specificity of each test were calculated with HSIL and squamous cell carcinoma (SCC) as the disease endpoint. Out of the 188 samples, 139 (74%) were positive for DNA of 14 HPV types, while 57 (30%) cases were positive for E6/E7 mRNA. The DNA test was positive in cytology cases of SCC, HSIL, and atypical squamous cell. The mRNA test yielded results of 75%, 74%, 60%, 56%, and 29% positivity in abnormal cytology cases of SCC, HSIL, atypical squamous cells – cannot exclude HSIL, atypical squamous cells of undetermined significance, and low-grade squamous intraepithelial lesion, respectively. In normal cytology cases, the positivity rates were 9% and 53% for the mRNA and DNA tests, respectively. For detection of HSIL and SCC, the sensitivity of the mRNA test was 74.36% and that of the DNA test was 100%, while the specificities of the tests were 85% and 40.83%, respectively. These findings suggest that the HPV E6/E7 mRNA assay can overcome the shortcoming of low specificity of DNA assays for clinical detection of high-grade cervical lesions and malignancies.     

人乳头状瘤病毒核酸检测试剂盒用于宫颈癌及癌前病变筛查的临床价值

目的分析人乳头状瘤病毒(HPV)杂交捕获-化学发光法核酸检测试剂盒(DH3)用于宫颈癌及癌前病变筛查的临床价值。方法收集480例妇科门诊妇女宫颈脱落细胞样本,分别采用DH3、TCT和HPV-PCR检测,对TCT≥ASC-US者行阴道镜下病理检测,以病理学结果为金标准,分析DH3诊断价值。结果病理学结果显示,正常者370例(77.08%),良性病变者(≤CINⅠ)59例(12.29%),高危者(≥CINⅡ)51例(10.63%);TCT、HPV-PCR和DH3诊断阳性率分别为26.04%、32.08%和27.08%;DH3与TCT检测一致率为94.79%(P0.01),与HPV-PCR检测一致率为93.13%(P0.01);DH3灵敏度98.18%,特异度87.57%,阳性预测值70.13%,阴性预测值99.39%,准确率为90%,检出高危型(≥CINⅡ)的ROC曲线面积Z=0.887(95%CI为0.785~0.918,P0.01)。结论 DH3试剂盒与TCT、HPV-PCR在检出HPV宫颈癌及癌前病变具有高度一致性,灵敏度、特异度和准确率高,操作便捷,临床筛查意义显著。     

FRD联合HR-HPV DNA、HPV E6/E7 mRNA检测对宫颈上皮内瘤变的诊断意义

目的探讨叶酸受体介导的宫颈特殊染色法(FRD)联合高危人乳头状瘤病毒(HR-HPV)DNA、人乳头状瘤病毒(HPV)E6/E7 mRNA检测对宫颈上皮内瘤变(CIN)的诊断意义。方法以2018年5月至2020年4月佛山市第一人民医院进行诊治的200例CIN患者作为观察组,另选取同期100例健康妇女作为对照组。对所有受试者进行FRD、HR-HPV DNA、HPV E6/E7 mRNA检测,比较2组受试者及不同病理分级CIN患者的检测结果。采用Spearman相关分析CIN诊断、病理分级与FRD、HR-HPV DNA、HPV E6/E7 mRNA检测阳性率的相关性,采用受试者工作特征(ROC)曲线评价FRD、HR-HPV DNA、HPV E6/E7 mRNA单独和联合检测对CIN的诊断效能。结果FRD检测CIN的假阳性率为3.00%,假阴性率为8.00%,2组FRD诊断CIN的准确率差异无统计学意义(P>0.05);CINⅡ级、Ⅲ级患者FRD检测的阳性率均高于CINⅠ级(P<0.05)。2组HR-HPV DNA、HPV E6/E7 mRNA检测诊断CIN准确率比较,差异均有统计学意义(P<0.05);CINⅡ级、Ⅲ级患者HR-HPV DNA、HPV E6/E7 mRNA检测的阳性率均高于CINⅠ级(P<0.05)。CIN诊断、病理分级与FRD、HR-HPV DNA、HPV E6/E7 mRNA检测的阳性率均呈正相关(r>0,P<0.05)。FRD、HR-HPVDNA、HPVE6/E7mRNA联合检测诊断CIN的曲线下面积(AUC)、灵敏度和特异度均明显高于单独检测诊断的AUC、灵敏度和特异度(P<0.05)。结论FRD、HR-HPV DNA、HPV E6/E7 mRNA联合检测对CIN具有较高的诊断效能,值得临床推广。     

HPV感染与宫颈疾病的相关性研究

目的 通过人乳头状瘤病毒（HPV）基因分型,探讨HPV感染与宫颈疾病发生发展的相关性.方法 采用导流杂交技术对186例临床宫颈疾病不同组别病例进行HPV基因分型检测分析.结果 HPV 21种基因型均已检出;HPV阳性检出率76.1%,HPV主要感染基因型依次为HPV16,58,33,52,68,31;HPV的检出率随宫颈病变程度的加重而增高,宫颈癌组、CIN III组显著高于慢性炎症组（P＜0.01）;HPV16型在各病例组中均居首位;HPV低危基因型6、11型以混合感染形式也出现在CIN I～CIN III和宫颈癌等病例组中.HPV混合感染率随疾病严重程度的增加而逐步减低.结论 随着宫颈病变程度的加重,HPV高危亚型检出率增高;提示临床对患者进行动态观察.     

高危型人乳头状瘤病毒16,18型DNA检测在宫颈病变筛查中的应用价值

目的评价高危型人乳头状瘤病毒16,18型(HPV16,18)DNA检测在宫颈病变筛查中的价值。方法收集209例病理组织学结果为癌及癌前病变[宫颈上皮内瘤变(CIN)Ⅰ、CINⅡ、CINⅢ、宫颈浸润癌]和296例病理组织学为良性病变(炎症、息肉等),并同时做了液基细胞学检查、HPV16,18 DNA检测的病例,统计比较HPV16,18 DNA检测与液基细胞学检查对癌及癌前病变的敏感性、特异性及阴性预测值;比较不同病变程度分类患者中HPV16,18的检出率。结果 209例癌及癌前病变患者中HPV16,18阳性158例,液基细胞学阳性[低级别鳞状上皮内病变(LSIL)、不除外高级别鳞状上皮细胞(ASC-H)、高级别鳞状上皮内病变(HSIL)、鳞状细胞癌]128例。296例宫颈良性病变患者HPV16,18阳性43例,液基细胞学阳性2例。HPV16,18 DNA检测对癌及癌前病变的敏感性为75.6%,液基细胞学为61.2%,两者比较差异有统计学意义(χ2=12.69,P<0.01),HPV16,18 DNA对癌及癌前病变的检出率明显高于液基细胞学。HPV16,18 DNA检测特异性为85.5%,阴性预测值为83.2%;液基细胞学特异性为99.3%,阴性预测值为78.4%;CINⅡ病变的HPV阳性检出率明显高于CINⅠ(χ2=6.69,P<0.05)。结论高危型HPV16,18感染与宫颈癌及宫颈癌前病变的发生、发展密切相关,HPV16,18 DNA检测对癌前病变和宫颈癌的敏感性高于液基细胞学、特异性低于液基细胞学,对宫颈炎、息肉等良性病变的阴性预测值高于液基细胞学,检测HPV16,18 DNA有着重要的临床价值。     

高危型人乳头瘤病毒检测及TCT检测在宫颈病变筛查中的应用

目的：探讨高危型人乳头瘤病毒（HPV）检测及液基超薄层细胞检测技术（TCT）在宫颈病变筛查中的诊断价值。方法：对782例妇女进行TCT检测并采用二代杂交捕获技术进行HPV检测,其中TCT结果≥非明确意义不典型鳞状细胞（ASCUS）或HPV（＋）者行阴道镜下活组织检查187例以及同期因子宫良性病变行子宫全切术的妇女107例术前全部做HPV及TCT检测,病理结果为金标准。结果：若将TCT结果≥ASCUS,病理结果≥宫颈上皮内瘤变I级（CINI）确定为阳性,应用HPV检测的阴性预测值高于TCT,差异有统计学意义（P〈O．05）。若将TCT结果≥低度鳞状上皮内病变（LSIL）确定为阳性,病理结果≥CINⅡ确定为阳性,HPV检测灵敏度及阴性预测值高于TCT检测,特异度、阳性预测值低于TCT检测,差异有统计学意义（P〈0．05）;TCT≥LSIL,病理≥CINⅡ为阳性与TCT≥ASCUS,病理≥CINI为阳性的评价指标分析,HPV检测的灵敏度、两种检测方法的阴性预测值均有明显提高,差异有统计学意义（P〈O．05）。结论：可将HPV检测作为宫颈病变筛查的第一步,它是可靠的阴性预测值,具有临床推广意义。     

第二代杂交捕获法诊断宫颈高度病变的临床评价

目的评价第2代杂交捕获法（HC2）检测13种高危型人乳头瘤病毒（HPV）用于诊断宫颈高度病变的效能。方法利用HC2检测292位妇女宫颈上皮细胞13种高危型HPV感染状况,以组织病理学检测结果为金标准评价HC2诊断宫颈高度病变[≥宫颈上皮内瘤变2级（CIN2）]的效能。结果≥CIN2组妇女13种高危型HPV感染率为95．56％（43／45）,〈CIN2组为66．40％（164／247）,两组间差异有统计学意义（X2：15．68,P〈0．001）。HC2诊断宫颈高度病变的敏感性为95．56％,特异性为33．60％,阳性预测值为20．77％,阴性预测值为97．65％,阳性似然比为1．44,阴性似然比为0．13。受试者工作特征（ROC）曲线分析发现,HC2诊断宫颈高度病变时曲线下面积为0．64,最佳诊断值为3．46pg／mL,此时方法的敏感性为93．30％,特异性为42．10％。结论宫颈高度病变与13种高危型HPV感染有关。HC2具有较高的敏感性和阴性预测值,但特异性和阳性预测值较低,临床上若用于宫颈高度病变的确诊,应与其他特异性较高的方法结合以提高其准确性。