The molecular test utilizes in vitro nucleic acid hybridization and signal amplification in a chemiluminescent microplate format for qualitative detection of 13 types of high-risk HPV DNA. This test was compared with the traditional Pap smear cytology of cervical specimens to ascertain the presence of malignancies.

A study of over 50,000 Mexican women, aged 20 to 70 years, underwent routine cytology and high risk (HR) HPV DNA testing. A second cervical specimen was collected for HR-HPV testing, using a conical cytobrush (Qiagen Inc., Gaithersburg, MD, USA), that was preserved in a specimen transport media test tube. All those who tested positive through cytology were referred to colposcopy, while the HPV DNA positive women were followed by repeat HPV DNA testing with colposcopy if they were repeat positive in one year. The study was carried out under the auspicies of the National Institute of Public Health of Mexico (INSP; Morelos, Mexico).

In women who were both cytology and HPV DNA positive the rate of precancer or cancer was 19.7 %, whereas the corresponding rate in women who were positive by cytology alone was only 3%. In women who were positive twice for HR HPV DNA (regarded as HPV persistent), the rate of precancer and/or cancers was 11.7 %. Overall, the sensitivity of HPV DNA testing for precancers and cervical cancers was 93.3% compared to only 40% for cytology testing.

Attila Lorincz, Ph.D., a professor at the Wolfson Institute of Preventive Medicine, (Barts and The London School of Medicine and Dentistry, London, UK), said, "The advantage of this new cervical cancer screening approach is that women who are HPV DNA positive can be quickly referred to colposcopy (within one year), thus catching the vast majority of the precancers and cancers. In contrast women who are HPV DNA negative can be safely made subject to much longer screening intervals saving considerable costs for the Mexican health system." The study was published in July 2010 in Cancer Causes & Control .

Related Links:
Qiagen Inc.
National Institute of Public Health of Mexico
Wolfson Institute of Preventive Medicine