Quick, accurate HPV test for developing countries

Medical Tribune November 2008 SFXIX
Seah Yee Mey and David Brill

A new rapid screening test for the human papilloma virus (HPV), created specifically for use in developing countries, is 90 percent accurate in detecting precancerous cervical disease, a study has shown.

careHPV is a signal-amplification assay adapted from the hybrid capture test, which is widely regarded as the gold standard in HPV DNA screening. Fourteen high-risk types of carcinogenic HPV can be detected using careHPV in about 2.5 hours.

The test takes up only a small area of clean bench-top space, with no need for mains electricity or running water supply. The short assay time allows for testing and clinical follow-up the same day.

careHPV can be operated by non-technical support staff with just 1 or 2 days of training.

The prototype was tested on 2,530 women aged 30 to 54 years in Shanxi province, eastern China, with complete data available for 2,388 women. careHPV correctly indentified precancerous cells in 90 percent of cervical specimens, while 84.2 percent of those without precancerous disease were identified as negative.

The recent publication of the findings online in The Lancet Oncology represents the culmination of a 5-year collaboration between the Program for Appropriate Technology in Health (PATH), a US-based nonprofit organization, and QIAGEN, who manufacture the test.

PATH, who receive funding for the project from the Bill and Melinda Gates Foundation, will now oversee a further 5 years of operational research in public health clinics in India, Uganda and Nicaragua.

The test still needs to be commercialized and undergo registration studies before it will be widely available, said Professor John Sellors, corresponding author of the study.

It is hoped that the 3 test countries will serve as examples for their respective regions, he added, noting that the generation of operational data will enable PATH to work alongside policy makers in other countries and help them to implement their own projects in future.

“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,” said Sellors, a professor of family medicine at McMaster University in Canada.

“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.”

The cost of careHPV is yet to be confirmed and will be negotiated on an individual basis with each government or organization.

careHPV was designed by Attila Lorincz, professor of molecular epidemiology at Barts and the London School of Medicine and Dentistry, UK. The prototype study in China was led by Professor You-Lin Qiao of the Cancer Institute, Chinese Academy of Medical Sciences, Beijing.

Cervical cancer is the second most common cancer in women, with some 500,000 new cases and 300,000 deaths worldwide every year. Carcinogenic HPV causes almost 100 percent of the cancers.