Liqui-Prep® Versus Conventional Papanicolaou Smear to Detect Cervical Cells Abnormality by Split-Sample Technique: A Randomized Double-Blind Controlled Trial

To assess the diagnostic performances of LiquiPrep (R) (LP) to detect cervical cellular abnormality in comparison to Papanicolaou (Pap) smear in 194 women with abnormal cervical cytology who were scheduled for colposcopy at the institution between January 2008 and November 2008. The women were randomized to undergo a repeated cervical cytologic evaluation by Pap smear followed by LP, or the two methods in alternating order. The pathologist was blinded to previous cytologic diagnosis and the pair of slides assigned for each woman. Cytologic results from each method were compared to subsequent histopathology. Mean screening time for each LP and Pap slides were 4.3 +/- 1.2 minutes and 5.4 +/- 1.1 minutes, respectively (P < 0.001). From 194 cases, ASC or AGC were diagnosed in 72 cases (37.1%) from LP and 68 cases (35.1%) from Pap smear. After excluding the ASC/AGC group, the overall cytologic diagnostic agreement between the two tests were 69 of 87 cases (73.6%) while the agreements with histologic diagnoses were 39/87 cases from LP (44.8%) and 41 (47.1%) from Pap smear (P = 0.824). The accuracy of LP was not significantly different from Pap test, 43.4% (95% confidence interval [CI]: 34.8-52.1%) compared to 44.4% (95% CI: 35.7-53.1%). LP did not have superior performance over Pap test to detect high-grade lesions (>= cervical intraepithelial neoplasia II) using ASCI AGC as the threshold with the sensitivity of 70.5% (95% CI: 64.0-76.9%) versus 77.3% (95% CI: 71.4-83.2%), respectively. Diagn. Cytopathol. 2011;39:22-27. (C) 2010 Wiley-Liss, Inc.