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

A 2003 comparison of the ThinPrep Pap Test vs. the conventional pap smear showed a 233% increase in HSIL detection.1

Diaz-Rosario 1999: 102% increase in HSIL detection2

A 1999 comparison of the ThinPrep Pap Test vs. the conventional pap smear found a 102% increase in HSIL detection.2

Learn more about the body of evidence

Read the Limaye abstract

Read the Diaz-Rosario abstract

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

A comparison of disease detection with the ThinPrep Imaging System vs. manually reviewed ThinPrep Pap Test slides reported a 37% increase in LSIL detection and a 42% increase in HSIL detection with the ThinPrep Imaging System.1,2

Learn more about the benefits of Dual Review

Read the Miller abstract

References

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.

See a list of key studies involving the ThinPrep
Pap Test and the ThinPrep Imaging System.

Get bibliography

See clinical guidelines on pap testing, HPV testing, and imaging technology.

Learn more

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