About the ThinPrep Imaging System

Benefits of the ThinPrep Imaging System with Dual Review

Dual Review screening means that every ThinPrep Pap Test gets two different reviews: one full review from the ThinPrep Imager, and then another from an experienced cytotechnologist. This Dual Review screening, which is available with the ThinPrep Pap Test and the ThinPrep Imaging System, has been proven to further reduce false negative rates — allowing for greater confidence in the results. There are several benefits of Dual Review screening compared to manually reviewed ThinPrep Pap Test slides.

Increased sensitivity and specificity over manually reviewed ThinPrep Pap Test slides1

After the vial leaves the physician's office, the screening process at the lab plays a key role in accuracy. The ThinPrep Imaging System utilizes advanced screening technology. The ThinPrep Imager scans every cell and cell cluster on the slide, measuring DNA content. It then identifies the largest and darkest nuclei, highlighting cells of interest for cytotechnologists' review.

Improved disease detection with the ThinPrep Imaging System1

Biopsy-confirmed data from independent studies showed improved disease detection with the ThinPrep Imaging System compared to manually reviewed ThinPrep Pap Test slides.2 In 2007, Miller and colleages reported a 37% increase in LSIL and a 42% increase in HSIL detection with the ThinPrep Imaging System compared to manually reviewed ThinPrep Pap Test slides.1,2

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

Reduced false-negative fraction

Only the ThinPrep Imaging System employs the Dual Review method in assessing every slide. Miller and colleagues showed that the ThinPrep Imaging System was found to have a 50% reduction in false negative fraction vs. manually reviewed ThinPrep Pap Test slides.2

Comparison of false negative fraction with the ThinPrep Imaging System vs. manually reviewed ThinPrep Pap Test slides2

In one study, use of the ThinPrep Imaging System with Dual Review resulted in a 50% reduction in false negative fraction over manually reviewed ThinPrep Pap Test slides.1,2

Decreases in unsatisfactory and ASC-US rates

Additionally, Miller and colleages found decreases in the unsatisfactory and ASC-US rates compared to manually reviewed ThinPrep Pap Test slides.2

Comparison of unsatisfactory and ASC-US rates with the ThinPrep Imaging System vs. manually reviewed ThinPrep Pap Test slides

The ThinPrep Imaging System showed a 67% decrease in unsatisfactory and a 15% decrease in ASC-US rates compared to manually reviewed ThinPrep Pap Test slides.

References

1. 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.

2. Miller FS, Nagel LE, Kenny-Moynihan MB. Implementation of the ThinPrep Imaging System in a high volume metropolitan laboratory. Diag Cytopath. 2007;35:213-7.

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