New HPV-DNA Test To Screen Women In Developing Countries For Cervical Precancerous Disease Has 90% Success Rate

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Cancer / Oncology
Article Date: 22 Sep 2008 - 2:00 PDT

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Results of a study to determine the accuracy of a new rapid screening test for HPV (human papillomavirus), created specifically for use in the developing world, have shown it to be 90% accurate in detecting precancerous cervical disease when tested on a group of women in Shanxi province, eastern China. The results, reported by You-lin Qiao and colleagues in an Article published early Online and in the October issue of The Lancet Oncology, conclude that the test - careHPV - could provide an effective primary screening method for cervical-cancer prevention in rural and low-resource settings.

Designed to be used in rural settings by personnel with minimal training, careHPV can detect 14 high-risk types of carcinogenic HPV in around 2•5 hours. Cytological screening - as routinely done in North America and Europe - has led to a 50-80% reduction in mortality, but it has not been possible to translate this expertise to the developing world, where taking smears properly and reading them has been problematic. Tested in collaboration with PATH (Seattle, WA, USA) and funded by the Bill & Melinda Gates Foundation, this new HPV-DNA screening test is rapid, simple, affordable, and appropriate for use in low-resource settings.

careHPV is a signal-amplification assay adapted from Hybrid Capture 2 (HC2), which is widely regarded as the gold-standard routine test for HPV DNA. It requires only a small area (approximately 25-30 cm) of clean bench-top work space, no mains electricity or running water, and can be done rapidly by non-technical support staff. The short assay time allows testing and clinical follow-up on the same day. The prototype was used in an outcomes study in Shanxi province, China, with 2388 local women aged 30-54 years. The ability of the careHPV test to detect precancerous cells was found to be 90•0%; 84•2% of the women without precancerous disease were identified as negative by the test.

Corresponding author John Sellors (Professor of Family Medicine, McMaster University, Hamilton, Canada), director of the 5-year project to develop and study the new test while at PATH, states: "From these results in China, careHPV looks very promising as a test that will allow the rapid and highly accurate screening of women in developing regions for cervical cancer. If women 30 years and older could be screened at least once in their lifetimes with such a test, and appropriate treatment administered at the same visit, public-health programmes would be affordable and deaths from cervical cancer would be reduced by a third".

Attila Lorincz (Professor of Molecular Epidemiology at Barts and The London School of Medicine and Dentistry) said: "The clinical performance of [this] new HPV test in China appears promising, it is based on decades of research, and I hope it will be employed widely to save the lives of millions of women. The new test needs to be studied in many countries to confirm its suitability for cervical cancer screening on the global stage."

Cervical cancer is the second most common cancer in women worldwide, with about 500 000 new cases and 300 000 deaths every year, over 85% occurring in the developing world. Almost all of these cancers are caused by carcinogenic types of HPV and - because it is possible to stop the infectious cycle and therefore the disease - are preventable. Vaccination against HPV shows promise for future generations and is currently being implemented in the UK, mostly in young school-aged girls. However, the current vaccine has some significant limitations because it is most effective against only two HPV types (16 and 18) that account for about 75% of cervical cancers. Additionally, the vaccine is ineffective in women who have been exposed to the virus (most women over the age of 20 years). Thus screening remains the main hope for the current generation of women aged 20 years or above and will need to be continued for at least the next 30 years.

"A new HPV-DNA test for cervical-cancer screening in developing regions: a cross-sectional study of clinical accuracy in rural China."
You-lin Qiao, John W Sellors, Paul S Eder, Yan-ping Bao, Jeanette M Lim, Fang-hui Zhao, Bernhard Weigl, Wen-hua Zhang, Roger B Peck, Ling Li, Feng Chen, Qing-jing Pan, Attila T Lorincz
The Lancet Oncology - DOI:10.1016/S1470-2045(08)70210-9
http://www.thelancet.com/journals/lanon

The Lancet Oncology