Rapid HPV Screening Test Evaluated in Rural China

A new human papillomavirus (HPV)-DNA test, created specifically for women in rural and low-resource settings, was evaluated in eastern China.

Called careHPV, the test was designed to be performed by personnel with minimal training. It can detect 14 high-risk types of carcinogenic HPV in around two and a half hours. Cytologic screening, which is routine 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 can be problematic.

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.

The results were reported by You-Lin Qiao of the Cancer Institute, Chinese Academy of Medical Sciences Peking Union Medical College (Peking, China) and colleagues in the September 2008 early online issue of the journal The Lancet Oncology. The investigators concluded that the test, careHPV, could provide an effective primary screening method for cervical-cancer prevention in rural and low-resource settings.

Corresponding author John Sellors, professor of family medicine, McMaster University (Hamilton, ON, Canada), director of the five-year project to develop and study the new test while at PATH (Seattle, WA, USA) stated, "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 programs would be affordable and deaths from cervical cancer would be reduced by a third.”

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.

CareHPV is being developed with Qiagen (Frankfurt, Germany) with support from PATH, a non-profit global health organization. A prototype should be ready by 2009.

Related Links:
Chinese Academy of Medical Sciences Peking Union Medical College
McMaster University
PATH
Qiagen