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Home-based Self-collected Vaginal Specimens Detect More Cervical Lesions and Cancers Than Cytology
Date:11/1/2011

a conical-shaped brush, to take the sample. The study used the digene® HPV test based on Hybrid Capture 2, which is considered the gold standard for HPV testing and already has been clinically validated in trials including more than one million women worldwide. The primary endpoint was CIN2 or worse, detected by colposcopy. Any woman having a positive result for either of the tests was referred to colposcopy.

The participation rate was higher in women randomized to the HPV group (9,202 of 9,371, 98%) than in the cytology group (11,054 of 12,731, 87%). Importantly, in the HPV group more invasive cancers were detected than with cytology (28 vs. 8). With a lower positive predictive value for HPV testing (PPV CIN2 or worse 12.2% vs. 90.5%) the identification of appropriate triage methods is crucial. The study adds: "Because women at these sites will be screened only a few times in their lives, the high sensitivity of a HPV screen is of paramount importance."

Based on data from several national trials including Hybrid Capture technology, Mexico is the first country to implement frontline HPV testing with cytology triage as a national cervical cancer prevention program. Dr. Nubia Munoz, Colombian Cancer Institute, Bogota, Colombia, and Dr. Rolando Herrero, Prevention and Implementation Group, International Agency for Research on Cancer, Lyon, France, conclude in an accompanying editorial in the Lancet: "The experience shows what can be achieved when scientific judgment guides public health policy."

"The value of HPV DNA testing in cervical cancer screening and disease detection has been proven again and again for both the developed and developing worlds. Self-collection for HPV DNA testing could become an important way for national cervical cancer prevention programs worldwide to increase coverage rates," said Dr. Helge Lubenow, Head of the Molecular Diagnostic Business at QIAGEN. "Our digene HPV testing solutions
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SOURCE QIAGEN N.V.
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