The ThinPrep Difference

The HSIL+ Clinical Outcomes Study

Study objective

To evaluate the ThinPrep Pap Test and the conventional pap smear for the detection of High Grade Squamous Intraepithelial and more severe lesions (HSIL+).

Study design*

  • A multi-site, prospective, historically-controlled, direct-to-vial study
  • Study sites consisted of ten leading academic hospitals in major metropolitan areas throughout the United States
  • From each site, patients were representative of a routine pap testing population and a referral population enrolled at the time of colposcopic examination
  • 10,226 ThinPrep Pap Test specimens were collected prospectively and were compared against an historical control cohort of 20,917 conventional pap smears
  • Conventional pap smears were collected sequentially from patients seen immediately prior to the initiation of the study by the same clinics and clinicians (as available) used to collect the ThinPrep Pap Test specimens

*Samples processed with the ThinPrep 2000 Processor

Study conclusion

The ThinPrep Pap Test increased HSIL+ detection by 59.7%, compared to the conventional pap smear in a multi-site, historically-controlled study of routine pap testing and referral patient populations at ten leading academic institutions.1

Percent change (%) = ((TP HSIL+/TP Total)/(CP HSIL+/CP Total))-1 x 100

References

1. ThinPrep Pap Test Package Insert "The results from this study showed a detection rate of 511/20,917 for the conventional Pap smear versus 399/10,226 for the ThinPrep slides. For these clinical sites and these study populations, this indicates a 59.7% increase in detection of HSIL+ lesions for the ThinPrep specimens."

2. ThinPrep Pap Test Package Insert.

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