Tag: HPV Test

Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses

hrHPV testing with an appropriate assay offers a promising new strategy that could increase population coverage substantially

What is already known on this topic

  • Tests performed on self samples are less sensitive and less specific than tests performed on clinician samples when using a high-risk human papillomavirus (hrHPV) assay based on signal amplification
  • Response rates for hrHPV testing are higher for self sampling kits than for conventional invitations

What this study adds

  • Tests performed on self samples are similarly sensitive and slightly less specific than tests performed on clinician samples when using a hrHPV assay based on polymerase chain reaction
  • Response rates for hrHPV testing continue to be higher for self sampling kits than for conventional invitations

2018 Study Abstract

Objective
To evaluate the diagnostic accuracy of high-risk human papillomavirus (hrHPV) assays on self samples and the efficacy of self sampling strategies to reach underscreened women.

Design
Updated meta-analysis.

Data sources
Medline (PubMed), Embase, and CENTRAL from 1 January 2013 to 15 April 2018 (accuracy review), and 1 January 2014 to 15 April 2018 (participation review).

Review methods
Accuracy review: hrHPV assay on a vaginal self sample and a clinician sample; and verification of the presence of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) by colposcopy and biopsy in all enrolled women or in women with positive tests. Participation review: study population included women who were irregularly or never screened; women in the self sampling arm (intervention arm) were invited to collect a self sample for hrHPV testing; women in the control arm were invited or reminded to undergo a screening test on a clinician sample; participation in both arms was documented; and a population minimum of 400 women.

Results
56 accuracy studies and 25 participation trials were included. hrHPV assays based on polymerase chain reaction were as sensitive on self samples as on clinician samples to detect CIN2+ or CIN3+ (pooled ratio 0.99, 95% confidence interval 0.97 to 1.02). However, hrHPV assays based on signal amplification were less sensitive on self samples (pooled ratio 0.85, 95% confidence interval 0.80 to 0.89). The specificity to exclude CIN2+ was 2% or 4% lower on self samples than on clinician samples, for hrHPV assays based on polymerase chain reaction or signal amplification, respectively. Mailing self sample kits to the woman’s home address generated higher response rates to have a sample taken by a clinician than invitation or reminder letters (pooled relative participation in intention-to-treat-analysis of 2.33, 95% confidence interval 1.86 to 2.91). Opt-in strategies where women had to request a self sampling kit were generally not more effective than invitation letters (relative participation of 1.22, 95% confidence interval 0.93 to 1.61). Direct offer of self sampling devices to women in communities that were underscreened generated high participation rates (>75%). Substantial interstudy heterogeneity was noted (I2>95%).

Conclusions
When used with hrHPV assays based on polymerase chain reaction, testing on self samples was similarly accurate as on clinician samples. Offering self sampling kits generally is more effective in reaching underscreened women than sending invitations. However, since response rates are highly variable among settings, pilots should be set up before regional or national roll out of self sampling strategies.

Whereas accuracy of new combinations of assays and self sampling devices can be evaluated in a diagnostic setting, acceptance and participation should be shown locally in a screening setting before general roll out.

Screening for Cervical Cancer – US Preventive Services Task Force Recommendation Statement

New Cervical Cancer Screening Guidelines: What You Need to Know

Some women have a new option for cervical cancer screening — and it doesn’t necessarily involve a Pap test — according to updated guidelines from a government-appointed panel of experts, livescience reports.

Key Points

  • Women under age 21 should not be screened for cervical cancer.
  • Women ages 21 to 29 should undergo screening every three years using a Pap test, also called “cervical cytology.” (HPV testing isn’t recommended for women ages 21 to 29 because, in this age group, HPV infection is common and is often cleared by the immune system.)
  • Women over age 65 do not need to be screened for cervical cancer if they are up to date on their screening, their tests in the previous 10 years were negative and they don’t have other risk factors for cervical cancer.

Abstract

Importance
The number of deaths from cervical cancer in the United States has decreased substantially since the implementation of widespread cervical cancer screening and has declined from 2.8 to 2.3 deaths per 100 000 women from 2000 to 2015.

Objective
To update the US Preventive Services Task Force (USPSTF) 2012 recommendation on screening for cervical cancer.

Evidence Review
The USPSTF reviewed the evidence on screening for cervical cancer, with a focus on clinical trials and cohort studies that evaluated screening with high-risk human papillomavirus (hrHPV) testing alone or hrHPV and cytology together (cotesting) compared with cervical cytology alone. The USPSTF also commissioned a decision analysis model to evaluate the age at which to begin and end screening, the optimal interval for screening, the effectiveness of different screening strategies, and related benefits and harms of different screening strategies.

Findings
Screening with cervical cytology alone, primary hrHPV testing alone, or cotesting can detect high-grade precancerous cervical lesions and cervical cancer. Screening women aged 21 to 65 years substantially reduces cervical cancer incidence and mortality. The harms of screening for cervical cancer in women aged 30 to 65 years are moderate. The USPSTF concludes with high certainty that the benefits of screening every 3 years with cytology alone in women aged 21 to 29 years substantially outweigh the harms. The USPSTF concludes with high certainty that the benefits of screening every 3 years with cytology alone, every 5 years with hrHPV testing alone, or every 5 years with both tests (cotesting) in women aged 30 to 65 years outweigh the harms. Screening women older than 65 years who have had adequate prior screening and women younger than 21 years does not provide significant benefit. Screening women who have had a hysterectomy with removal of the cervix for indications other than a high-grade precancerous lesion or cervical cancer provides no benefit. The USPSTF concludes with moderate to high certainty that screening women older than 65 years who have had adequate prior screening and are not otherwise at high risk for cervical cancer, screening women younger than 21 years, and screening women who have had a hysterectomy with removal of the cervix for indications other than a high-grade precancerous lesion or cervical cancer does not result in a positive net benefit.

Conclusions and Recommendation
The USPSTF recommends screening for cervical cancer every 3 years with cervical cytology alone in women aged 21 to 29 years. (A recommendation) The USPSTF recommends screening every 3 years with cervical cytology alone, every 5 years with hrHPV testing alone, or every 5 years with hrHPV testing in combination with cytology (cotesting) in women aged 30 to 65 years. (A recommendation) The USPSTF recommends against screening for cervical cancer in women younger than 21 years. (D recommendation) The USPSTF recommends against screening for cervical cancer in women older than 65 years who have had adequate prior screening and are not otherwise at high risk for cervical cancer. (D recommendation) The USPSTF recommends against screening for cervical cancer in women who have had a hysterectomy with removal of the cervix and do not have a history of a high-grade precancerous lesion or cervical cancer.

Recommendations of Others

… “Women at increased risk of cervical cancer (ie, women with a history of cervical cancer, a compromised immune system, or diethylstilbestrol exposure) may need to be screened more often.” …

Reference. US Preventive Services Task Force, August 21, 2018.

USPSTF Draft Recommendation Statement Cervical Cancer : Screening

The US Preventive Services Task Force has New Draft Guidance for Cervical Cancer Screening

These recommendations do NOT apply to women with in utero exposure to diethylstilbestrol or women who have a compromised immune system (e.g., women living with HIV).

The major change from the US Preventive Services Task Force (USPSTF) 2012 recommendation is that testing for high-risk strains of human papillomavirus (hrHPV) alone is now recommended as an alternative to cytology or Papanicolaou (Pap) screening alone beginning at age 30 years; cotesting is no longer recommended.

As in the 2012 recommendation, the USPSTF continues to recommend that women aged 21 to 29 years undergo Pap screening every 3 years.

The USPSTF recommend against screening in women younger than age 21 years because there is adequate evidence that regardless of sexual history, screening younger women does not reduce cervical cancer incidence or mortality.

The USPSTF also continues to give a thumbs down to screening in women older than age 65 years who have had adequate prior screening and are not otherwise at high risk for cervical cancer, as well as in women who have had a hysterectomy and their cervix removed and do not have a history of a high-grade precancerous lesions or cervical cancer.

More Information

2016 Changes to Cervical Cancer Screening in the UK

Screening samples will now be tested for human papilloma virus (HPV) first

In the United Kingdom, women aged 25 to 49 are invited for cervical screening every 3 years and from 50 to 64 every 5 years.

The process of cervical screening is to be changed to allow women to benefit from more accurate tests. After a successful pilot programme and a recommendation by the UK National Screening Committee, screening samples will be tested for human papilloma virus (HPV) first. This will be rolled out across England as the primary screening test for cervical disease.

Current testing process

At the moment, cervical screening samples are first tested using the cytology test. The sample is examined for abnormal cells that could go on to develop into cancer. However, the cytology test leaves room for abnormal cells to be missed, as they sometimes look similar to normal cells. Normal cells can also be misdiagnosed as abnormal.

Testing for (HPV is used as a secondary measure for samples needing further investigation. Women with mild or borderline cytology results are tested for HPV and if negative are returned to the routine screening programme. Women who are HPV positive are referred for a colposcopy, a medical examination of the cervix.

New testing process

In the new process, the sample will be tested for HPV first.

The majority (99.7%) of cervical cancers are caused by persistent HPVinfection, which causes changes to the cervical cells. If HPV is found it is a useful guide as to whether abnormal cells are present. Women can then be monitored more closely and any developing abnormal cells found sooner. If no HPV is present the test also minimises over-treatment and anxiety for women.

” These changes are a breakthrough in the way we test women for cervical disease. The new test is more accurate, more personal and will reduce anxiety among women.
Cervical screening currently saves 4,500 lives a year, and this new test will ensure the early signs are spotted and treated earlier. “

said Jane Ellison, Public Health Minister.

The new testing process could prevent around 600 cancers a year, according to Cancer Research UK.

” It’s a huge step forward that the government is now introducing the HPVtest to improve cervical screening. Testing first for the human papilloma virus will help prevent more cervical cancers, as it can pick up the cancer-causing infection before any abnormalities can develop in the cells.

The need for improvements to the cervical screening programme was set out in the cancer strategy for England last year, so it’s good to see progress being made. “

said Sir Harpal Kumar, Cancer Research UK’s chief executive.

Original news story by Gov.UK Department of Health, 6 July 2016.

Cervical Cancer Screening with the HPV test and Pap Test

When to Get Tested and How to Make Sense of Your Test Results

Cervical-Cancer-Screening cover image
When to Get Tested and How to Make Sense of Your Test Results.

Sources and more information

On Flickr®

Preventing Cervical Cancer Infographic

Prevent Cervical Cancer with the Right Test at the Right Time

prevent-cervical-cancer infographic
Prevent Cervical Cancer with the Right Test at the Right Time.
Watch @DES_Journal diaporama and infographics album on Flickr. Image via @CDC_Cancer.

On Flickr®

Cervical Cancer: an overview of the NCI fact sheet on Pap and HPV testing

Pap and HPV Testing fact sheet, National Cancer Institute

Pap-and-HPV-Testing image
Screening for cervical cancer is in the news. Below is an overview of @theNCI fact sheet on Pap and HPV testing.

Key Points

  • Cervical cancer screening, which includes the Pap test and HPV testing, is an essential part of a woman’s routine health care because it can detect cancer or abnormalities that may lead to cancer of the cervix.
  • Current guidelines recommend that women should have a Pap test every 3 years beginning at age 21. These guidelines further recommend that women ages 30 to 65 should have HPV and Pap cotesting every 5 years or a Pap test alone every 3 years. Women with certain risk factors may need to have more frequent screening or to continue screening beyond age 65.
  • Women who have received the HPV vaccine still need regular cervical screening.

Questions

  • What causes cervical cancer?
  • What is cervical cancer screening?
  • How is cervical cancer screening done?
  • When should a woman begin cervical cancer screening, and how often should she be screened?
  • What are the benefits of Pap and HPV cotesting?
  • Can HPV testing be used alone for cervical cancer screening?
  • How are the results of cervical cancer screening tests reported?
  • What follow-up tests are done if cervical cancer screening results are abnormal?
  • How are cervical abnormalities treated?
  • Do women who have been vaccinated against HPV still need to be screened for cervical cancer?
  • What are the limitations of cervical cancer screening?

Read Pap and HPV Testing fact sheet, National Cancer Institute.

More information
  • Cervical Cancer Risk for 330,000 Women Undergoing Concurrent HPV Testing and Cervical Cytology in Routine Clinical Practice at a Large Managed Care Organization, PMC3272857, Feb 6, 2012.
  • Screening for cervical cancer: U.S. Preventive Services Task Force recommendation statement, annals 1183214, 19 June 2012 .
  • American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer, PMC3801360, Mar 14, 2012.
  • Human papillomavirus and cervical cancer, PubMed 17826171, 2007 Sep 8.
  • Human papillomavirus testing in the prevention of cervical cancer, PMC3046952, Mar 2, 2011.
  • Natural history of human papillomavirus infections, cytologic and histologic abnormalities, and cancer, PubMed 19061814, 2008 Dec.
  • Reassurance Against Future Risk of Precancer and Cancer Conferred by a Negative Human Papillomavirus Test, JNCI 106/8/dju153, May 2, 2014.

Did you take the Gardasil Cervarix HPV Vaccine Survey?

Hormones Matter has been struck by the depth and breadth of adverse events experienced by young girls and women who have been given the HPV vaccines Gardasil or Cervarix

Lucine women logo
Hormones Matter has been struck by the depth and breadth of adverse events experienced by young girls and women who have been given the HPV vaccines Gardasil or Cervarix.

” At Hormones Matter we have been struck by the depth and breadth of adverse events experienced by young girls and women who have been given the HPV vaccines Gardasil or Cervarix. Anecdotal evidence is great, but objective data are better. We must resolve this issue, our daughter’s lives depend upon it.

We need your help to gather the data to understand the real prevalence of side-effects, the range and severity of side-effects and who is most at risk for these complications. Please take this survey and share it with your friends, sisters, colleagues and anyone you know who has been given the HPV vaccine. We will need thousands of women to find the connections. That requires crowdsourcing and sharing amongst women.

The survey is anonymous.

Because of the age of some of the girls given the HPV vaccine and the severity of the adverse events that include death and severe disability, we allow parents, family members and/or friends to take the survey for the affected individual.

Finally, this is a long survey, approximately 30 minutes. We wish it were shorter, but both the depth of the information and the limitations of survey software combine to make this a longer than desired survey. Given that some girls and women are dying or suffering from life long adverse events, we felt it was more important to be thorough than short and incomplete.

We will be creating a second survey, over the coming months, to assess the adverse events in boys and men now being given the vaccine.

Thank you in advance for taking the survey. ”

Sources and more information

FDA Panel recommends Roche HPV Test as Primary Tool for Cervical Cancer Screening

Can Roche’s DNA Test Replace Pap Smear?

image of roche hpv test
The Roche cobas® HPV Test is seen as better primary tool for cervical cancer screening.

The Food and Drug Administration‘s Medical Devices Advisory Committee Microbiology Panel agreed by a vote of 13-0 that a HPV test developed by Roche should be approved by the FDA as a primary tool for cervical cancer screening.

Currently, women are tested for human papillomavirus (HPV) during a Pap test – examining a cervical sample under the microscope looking for abnormalities. – or after a Pap smear shows abnormal changes on their cervix. The new cobas® HPV test from Roche detects the DNA of human papillomavirus which causes almost all cases of cervical cancer.

Sources and More Information

Could Cervical Cancer be prevented by earlier HPV Tests?

Clinical Human Papillomavirus Detection Forecasts Cervical Cancer Risk in Women Over 18 Years of Follow-Up

Cervical Cancer could be prevented by earlier HPV Tests, Study suggests
HPV tests could prevent cervical cancer cases

Carrying out a virus test before traditional cervical screening could prevent around 600 cases of cancer a year in England, research suggests. Scientists found that more than 40% of 8,750 women with cervical cancer had received a negative screening test result within six years of their diagnosis. They then predicted how many more cases of cervical cancer would have been avoided if human papilloma virus (HPV) testing had been used ahead of screening for abnormal cells.

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