Please share your oppinion:

请分享你的观点

Recently I noticed this topic in another cytology website in China. Let us have a discussion here.

最近我在另一个中国的细胞学网站中注意到这个主题。让我们一起在这里讨论。

1. Are all cervical carcinoma related to HPV infection?

所有的宫颈癌都是由HPV导致的吗？

2. When the women or who should have high risk HPV (hrHPV) testing?

那些女性需要或者什么时候做高危HPV检测呢？

3. What methods to detect hrHPV do you used in your hospitals?

你们医院用的是那种方法检测高危HPV？

4. What should the women do if she has positive hrHPV result?

如果她的高危HPV的结果是阳性的，她们该怎么办？

5. hrHPV testing should be performed for women with AGC?

细胞学结果为AGC的女性应该进行高危的HPV检测吗？

6. Any question, experience or oppinion you have, please share or discuss.

所有以上问题，就你个人的观点或经验来分享和讨论吧。

We as pathologists should know some basic information about HPV even though HPV testing might not be oerformed in your hospital, or the patients might not be able to pay for the test.

 即使HPV检测在你们医院没有开展或病人没有经济能力支付这项检测。我们做为病理学医生应该知道一些关于HPV的基本知识。 

good thought

USA FDA approved Roche HPV test can be used as the primary screening for the women 25 years and older. FDA approved it based on the clinial trial. But currently no clinical data demonstrate the safity of the approach.

巴山夜雨涨秋池: Good point. Thanks. Still is there no one in the web knowing you in person?

 请教在中国现在有否用HPV 检查做为唯一的宫颈癌筛查方法？

HPV test as a primary test is a big news in cervical cancer screening. It needs time for people to accept the concept and also it needs more clinical data to support the new screening way.

In April 2014 US FDA approved cobas HPV test can be used as a primary screening test for women 25 and older.

Currently there are three optios for cervical cancer screening in the USA:

1. Pap test for women 21 or older, every three years

2. Cotesting (Pap+HPV) for women 30 and older, every five years

3. cobas HPV test for women 25 and older.

FDA NEWS RELEASE

For Immediate Release: April 24, 2014
Media Inquiries: Susan Laine, 301-796-5349, susan.laine@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves first human papillomavirus test for primary cervical cancer screening 

The U.S. Food and Drug Administration today approved the first FDA-approved HPV DNA test for women 25 and older that can be used alone to help a health care professional assess the need for a woman to undergo additional diagnostic testing for cervical cancer. The test also can provide information about the patient’s risk for developing cervical cancer in the future.

Using a sample of cervical cells, the cobas HPV Test detects DNA from 14 high-risk HPV types. The test specifically identifies HPV 16 and HPV 18, while concurrently detecting 12 other types of high-risk HPVs. 

Based on results of the cobas HPV Test, women who test positive for HPV 16 or HPV 18 should have a colposcopy, an exam using a device that illuminates and magnifies the cervix so a physician can directly observe the cervical cells. Women testing positive for one or more of the 12 other high-risk HPV types should have a Pap test to determine the need for a colposcopy. Health care professionals should use the cobas HPV Test results together with other information, such as the patient screening history and risk factors, and current professional guidelines.    

“Today’s approval offers women and physicians a new option for cervical cancer screening,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health. “Roche Diagnostics conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness when used as a primary screening tool for cervical cancer.”

The FDA first approved the test, called the cobas HPV Test in 2011 for use in conjunction with or as a follow-up to a Pap test (cell cytology), which examines cervical cells for changes that might become cervical cancer.

Today’s approval expands the use of the test to include use as either a co-test or as a primary cervical cancer screening test, however; it does not change current medical practice guidelines for cervical cancer screening. These guidelines are developed, reviewed and modified by groups other than the FDA.

Genital HPVs are a group of more than 40 related viruses and, according to the Centers for Disease Control and Prevention (CDC), are the most common sexually transmitted infections. Approximately 14 “high-risk” HPV types are associated with cervical cancer. 

In most cases, a high-risk HPV infection goes away on its own and does not cause any health problems. However, about 10 percent of women infected with high-risk HPV develop a persistent infection which may put them at risk of cancer. Virtually all cervical cancers are caused by HPV infections, with just two types, HPV 16 and HPV 18, responsible for approximately 70 percent of cervical cancers.

Data supporting the use of the cobas HPV Test as a primary screening test for cervical cancer included a study of more than 40,000 women 25 years and older undergoing routine cervical exams. Women who had a positive Pap test or whose cervical cells screened positive for HPV, as well as a subset of women whose Pap and HPV tests were both negative, underwent a colposcopy and cervical tissue biopsy. All biopsy results were compared to the Pap and cobas HPV Test results. Data from this study, which included three years of follow-up on women who went to colposcopy, showed that the cobas HPV Test is safe and effective for the new indication for use. 

The cobas HPV Test is manufactured by Roche Molecular Systems, Incorporated, Pleasanton, Calif.

You did right thing

Interesting. It is easy for clinicians to get the money. ha

30岁以下如可见挖空细胞的也会建议做HPV检测.

can you tell why? where did you learn this?

About discussion and analysis are very good and reasonable. thanks,

 recently above short paper "commentary statment on HPV DNA test utilization" was published in several main pathology journals authourity guideline in the USA.  I pasted the main points above for your reference. Basically the statement just repeat ed and highlighted the ASCCP guideline about HPV test. However they did not include some new study data. Many recent study results indicated that HPV DNA testing may be useful for women with ASC-H and AGC Pap. 以上是最近刊登在美国几家主要病理学杂志指导原则性的“关于HPV-DNA检测的应用的解释和说明”简报。我摘录主要内容供大家参考。基本上是基于ASCCP的指导原则上的重复声明。但是他们没有包括最新的研究数据。许多最新的研究是关于HPV-DNA检测在ASC-H和AGC的意义。

掌心0164译

Commentary Statement on human papillomavirus DNA test utilization

关于HPV-DNA检测应用的解释和说明

Diane Solomon, Jacalyn L. Papillo, Diane D. Davey, for the Cytopathology Education and Technology Consortium (CETC)  来源细胞病理学教育和技术协会（CETC）

*Correspondence to Diane Solomon, Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Executive Plaza North, Room 2130, 6130 Executive Blvd., Rockville, MD 20852 

This article is being published jointly in 2009 in Cancer Cytopathology (online: May 4, 2009; print: June 25), Journal of Lower Genital Tract Disease, Diagnostic Cytopathology, Acta Cytologica (print: May/June), American Journal of Clinical Pathology, and Archives of Pathology and Laboratory Medicine. 本文发表在2009年联合出版的《癌症细胞病理学》（在线：2009年5月4日；印刷：6月25日）、《下生殖道疾病杂志》、《诊断细胞病理学》、《兽类细胞学》（印刷：5月/6月）、《美国临床病理学杂志》和《病理学和实验医学档案》

1 High-risk (oncogenic) HPV DNA testing is appropriate in the following circumstances: 高危（致癌）HPV-DNA检测适用以下情况：

1.1 Routine cervical cancer screening in conjunction with cervical cytology (dual testing or co-testing) for women aged 30 years:

1.1：例行与细胞学（双测试或联合测试）联合进行宫颈癌筛查的30岁及以上女性。

1.1.1 For women who are cytology negative but HPV positive, repeat both tests in 12 months (As of March 2009, the US Food and Drug Administration approved an HPV type 16/18 genotyping test; as per ASCCP guidelines, HPV 16/18-positive women aged 30 years are referred directly for colposcopy.) 对于细胞学阴性而HPV阳性的女性，在12月内重复细胞学和HPV检测（截止2009年3月，美国FDA批准了16/18型基因分型检测；按ASCCP指导原则，HPV16/18阳性的30岁及以上的女性应直接阴道镜检查）

1.1.2 For women who are both cytology and HPV negative, repeat both tests only after a 3-year interval. 对于细胞学和HPV都是阴性的女性，仅需每3年进行细胞学和HPV的筛查。

1.2 Initial triage management of women aged 21 years with a cytologic result of atypical squamous cells of undetermined significance (ASC-US). 对于细胞学结果为ASCUS的21岁及以下的女性进行初步分流管理。

1.3 Initial triage management of postmenopausal women with a cytologic result of low-grade squamous intraepithelial lesion (LSIL). 对于细胞学结果为LSIL的绝经之后的女性进行初步分流管理。

1.4 Postcolposcopy management of women of any age with an initial cytologic result of atypical glandular cells (AGC) or atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion (ASC-H) (when the initial workup does not identify a high-grade lesion). 对于初始细胞学结果为AGC或ASC-H（当初始不能确定为高度病变）任何年龄的女性进行阴道镜后的管理。

1.5 Postcolposcopy management of women aged 21 years with initial cytologic results of ASC-US or LSIL (when the initial colposcopy does not identify a high-grade lesion). 对于初始细胞学结果为ASCUS或LSIL（当初始阴道镜不能确定为高度病变）年龄在21岁及以下的女性进行阴道镜后的管理。

1.6 Post-treatment surveillance. 治疗后监测。 

2 High-risk (oncogenic) HPV DNA testing is generally not appropriate in the following situations: 高危（致癌）HPV-DNA检测一般不适用以下情况：

2.1 Routine cervical cancer screening in women aged <30 years. 例行宫颈癌筛查的30岁及以下女性。

2.2 Routine screening with HPV testing and cervical cytology more often than every 3 years for women aged 30 years whose tests were negative at the time of last screening (see 1.1.2 above). 最近一次结果为阴性而每3年例行HPV检测和细胞学筛查的30岁及以上女性（参考1.1.2）。

2.3 Initial triage or management of adolescents (aged  20 years) with any abnormal cytologic result. Furthermore, if HPV testing is inadvertently performed, the results should not be used to influence patient management. 初步分流或管理任何细胞学结异常果的青少年（20岁及以下）。此外，如果HPV检测是在无意中执行的，结果不应该被用来对病人进行管理。

2.4 Initial triage of LSIL (except for postmenopausal women; see 1.3 above).

初步分流细胞学结果为LSIL的女性（除外绝经后女性，参考1.3）。

2.5 Initial triage of ASC-H, high-grade squamous intraepithelial lesion (HSIL), or AGC/adenocarcinoma in situ (AIS) in women of any age. 初步分流细胞学结果为ASC-H、HSIL、AGC/AIS的任何年龄女性。

3 Repeat high-risk (oncogenic) HPV DNA testing should generally not be performed within <12 months: 一般不在12个月内重复高危（致癌）HPV-DNA检测。

3.1 Exceptions include as a follow-up to AGC, not otherwise specified (AGC NOS) when no pathology is found at the time of the initial workup and as follow-up after treatment for cervical intraepithelial neoplasia grades 2 and 3 (CIN 2,3). See the ASCCP guidelines for specific recommendations concerning testing intervals作为在开始病理结果未发现异常而随访中诊断CIN2和CIN3的AGC-NOS随访除外。具体的检测间隔时间参考ASCCP指导原则。

4 Testing for low-risk (nononcogenic) HPV types has no role in routine cervical cancer screening or for the evaluation of women with abnormal cervical cytology. 对于宫颈癌的筛查或异常宫颈细胞学的评估进行低危（非致癌）HPV检测没有意义。

 Wish our Chinese pathologists can know some large pictures about this Pap screening issue. Relative high percentage of cervical cancer patients  are in China. We all Chinese pathologists should have some responsibilites to reduce the rate of cervical cancer in China.

I can mail you the full papers if you are interested and cannot fine the full papers.My eamil zhaoc@upmc.edu

cz

希望我们中国病理学家们知道一些关于巴氏筛查相关问题的大型资料。在中国有相对高比例的宫颈癌患者。我们所有的中国病理学家们应该出一份力来降低中国宫颈癌的比率。
如果你有兴趣而没有找到全文；我可以发送给您。My eamil ：zhaoc@upmc.edu

 Pasted this abstract again.

J Natl Cancer Inst. 2009 Jan 21;101(2):88-99. Epub 2009 Jan 13.

 Above are recent four large clinical cervical cancer screening trials. All these papers were published in very high level medical journals.以上是最近四个大型宫颈癌筛查的临床试验。所有这些论文已刊登在非常高水平的医学期刊中。

We can see clearly their conclusions are different.我们可以清楚地看到他们得出了不同的结论。

1.  

Lancet Oncol.柳叶刀肿瘤学 2009 Jul;10(7):672-82. Epub 2009 Jun 17.

HPV testing in combination with liquid-based cytology in primary cervical screening (ARTISTIC): a randomised controlled trial.

Conclusion: LBC combined with HPV testing resulted in a significantly lower detection rate of CIN3+ in the second round of screening compared with LBC screening alone, but the effect was small. Over the two screening rounds combined, co-testing did not detect a higher rate of CIN3+ or CIN2+ than LBC alone. Potential changes in screening methodology should be assessed over at least two screening rounds.

结论： 液基细胞学结合HPV检测同单用液基细胞检测比较应该在第二轮的筛查中大大降低CIN3+检出率，但是影响不大。在两轮筛查相结合，共同检测并没有发现率较高CIN3+或CIN2+比单独的液基细胞学。潜在的变化，在评估筛选方法至少应该进行两轮筛查。 

2.

N Engl J Med. 2009 Apr 2;360(14):1385-94.

HPV screening for cervical cancer in rural India. 在印度农村地区进行HPV筛查宫颈癌

A new HPV-DNA test for cervical-cancer screening in developing regions: a cross-sectional study of clinical accuracy in rural China.

Cancer Institute, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China.

BACKGROUND: A new test (careHPV; QIAGEN, Gaithersburg, MD, USA) has been developed to detect 14 high-risk types of carcinogenic human papillomavirus (HPV) in about 2.5 h, to screen women in developing regions for cervical intraepithelial neoplasia (CIN). We did a cross-sectional study to assess the clinical accuracy of careHPV as a rapid screening test in two county hospitals in rural China. METHODS: From May 10 to June 15, 2007, the careHPV test was done locally by use of self-obtained vaginal and provider-obtained cervical specimens from a screening population-based set of 2530 women aged 30 to 54 years in Shanxi province, China. All women were assessed by visual inspection with acetic acid (VIA), Digene High-Risk HPV HC2 DNA Test (HC2), liquid-based cytology, and colposcopy with directed biopsy and endocervical curettage as necessary. In 2388 women with complete data, 441 women with negative colposcopy, but unsatisfactory or abnormal cytology or who were positive on HC2 or the new careHPV test, were recalled for a second colposcopy, four-quadrant cervical biopsies, and endocervical curettage. An absence of independence between the tests was not adjusted for and the Bonferroni correction was used for multiple comparisons. FINDINGS: Complete data were available for 2388 (94.4%) women. 70 women had CIN2+ (moderate or severe CIN or cancer), of whom 23 had CIN3+. By use of CIN2+ as the reference standard and area-under-the-curve analysis with a two-sided alpha error level of 0.0083, the sensitivities and specificities of the careHPV test for a cut-off ratio cut-point of 0.5 relative light units, were 90.0% (95% CI 83.0-97.0) and 84.2% (82.7-85.7), respectively, on cervical specimens, and 81.4% (72.3-90.5) and 82.4% (80.8-83.9), respectively, on vaginal specimens (areas under the curve not significantly different, p=0.0596), compared with 41.4% (29.9-53.0) and 94.5% (93.6-95.4) for VIA (areas under the curve significantly different, p=0.0001 and p=0.0031, for cervical and vaginal-specimen comparisons for the careHPV test, respectively). The sensitivity and specificity of HC2 for cervical specimens were 97.1% (93.2-100) and 85.6% (84.2-87.1), respectively (areas under the curve not significantly different from the careHPV test on cervical specimens, p=0.0163). INTERPRETATION: The careHPV test is promising as a primary screening method for cervical-cancer prevention in low-resource regions.