The ThinPrep Difference
Diagnostic Superiority of
the ThinPrep Pap Test
Clinical studies have confirmed that the ThinPrep Pap Test is significantly more effective than the conventional pap smear. This, combined with advanced technology of the ThinPrep Imaging System with Dual Review, is helping to bring standards in cervical disease detection to new levels.
Increased HSIL detection
Several large, independent studies have confirmed increased HSIL detection with the ThinPrep Pap Test compared to the conventional pap smear. A 2003 study by Limaye and colleagues performed at the nation’s largest laboratory found a 233% increase in HSIL detection.1 An earlier large study in 1999 by Diaz-Rosario and colleagues showed a 102% increase in HSIL detection with the ThinPrep Pap Test vs. the conventional pap smear.2 Both studies also found increases in LSIL detection as well.1,2
Limaye, 2003: 233% increase in HSIL detection1
Diaz-Rosario 1999: 102% increase in HSIL detection2
Dual Review: additional disease detection over manually reviewed ThinPrep Pap Test slides
Clinical studies have also shown that the ThinPrep Imaging System with Dual Review provides additional disease detection over manually reviewed ThinPrep Pap Test slides. A 2007 study by Miller and colleagues found a 42% increase in HSIL detection and a 37% increase in LSIL detection compared to manually reviewed ThinPrep Pap Test slides.3 Other improvements were also reported, including a reduced false-negative fraction and decreases in the unsatisfactory and ASC-US rates.3
Miller, et al. 2007: improved LSIL and HSIL detection with the ThinPrep Imaging System1
1. Limaye A, Connor AJ, Huang X, Luff R. Comparative analysis of conventional papanicolaou tests and a fluid-based thin-layer method. Arch Pathol Lab Med. 2003;127:200-4. *Data reported from Period 2. In Period 1, ThinPrep demonstrated a 160% increase in SIL; LSIL and HSIL detection were not broken out. In the Direct-to-vial HSIL+ study, a 59.7% increase in HSIL+ lesions was shown over the conventional Pap.
2. Diaz-Rosario L, Kabawat S. Performance of a fluid-based, thin-layer papanicolaou smear method in the clinical setting of an independent laboratory and an outpatient screening population in New England. Arch Pathol Lab Med. 1999;123:817-21.
3. Miller, et al. Implementation of the ThinPrep Imaging System in a High Volume Metropolitan Laboratory. Diag Cytopath. 2007;35:213-7.
4. The Imager clinical trial results showed a statistically significant increase in ASCUS+ sensitivity of 6.4% [95% CI: 2.6-10.0], a statistically significant increase in HSIL+ specificity of 0.2% [95% CI: 0.06-0.4], and a reduction in false negative fraction of 39% (based on ASCUS+ sensitivity). The unsatisfactory rate was not evaluated for statistical significance, but a decrease was observed.