Does the ThinPrep® Pap Test detect more abnormals than the conventional Pap smear?
FDA approval of the ThinPrep Pap Test as a replacement for the conventional Pap smear and the claim that the ThinPrep Pap Test is “significantly more effective” was based on extensive data submitted from a multi-site clinical trial. This study of 6747 women was conducted using a multi-site, double-blinded protocol. Performance based on initial screening was validated by independent pathologist review. The results of this study indicate that the ThinPrep Pap Test significantly increases the detection of low-grade or more severe lesions by 65% in screening populations and 6% for high risk populations when compared with the conventional Pap smear.
