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First Published Study of New HPV Test for Developing Countries Shows High Accuracy in Predicting Cervical Disease
Date:9/21/2008

very affordable price."

The first published study of patient outcomes with careHPV involved more than 2,500 women age 30-54 in mostly rural areas of China. In developed regions with established public health budgets and programs, Pap testing (cytology) is the standard screen for cervical disease, supplemented by HPV testing in women over the age of 30 (who are most at risk). However, both the Pap and the current HPV test require "a level of infrastructure unattainable in most of the developing world," write the paper's authors. Thus, the most common cervical cancer screening tool in low-resource regions of China and similar countries has been visual inspection with acetic acid (VIA) -- a procedure in which a woman's cervix is painted with vinegar to highlight any abnormal areas present, then visually examined by a doctor or nurse. However, VIA misses a significant number of women with cervical disease who need treatment: In the study published in Lancet Oncology, the "sensitivity" of VIA (its ability to identify women who have moderate or severe cervical disease, also called CIN2+) was 41 percent. In contrast, the sensitivity of careHPV was 90 percent when samples of cervical cells collected by healthcare workers were used, and 81 percent when women used a vaginal "self-sampling" device. In this study, careHPV was more sensitive even than the newer, liquid-based Pap testing, for which the sensitivity was 85 percent when the sample was collected in the doctor's office. Pap testing, which requires trained technicians to interpret, is the primary screening tool in many countries.

The careHPV test can be conducted by workers with minimal healthcare training and education. Once collected, samples of vaginal or cervical cells are prepared for analysis using a kit of reagents that contains its own water supply. The testing itself is conducted on easily portable equipment and will run on batteries.

"In countries with scarce resources, women often live
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