Laboratory implementation and efficacy assessment of the ThinPrep cervical cancer screening system.

OBJECTIVE

To assess the efficacy of a new fluid-based, automated, thin-layer system for cervical screening, in routine use in our clinical laboratory.

STUDY DESIGN

Data from 39,408 conventional cervical cytologic smears and 10,694 ThinPrep slides collected concurrently were analyzed to compare diagnostic detection rates, specimen adequacy, sensitivity and specificity.

RESULTS

The ThinPrep slides yielded a significantly higher proportion of low grade squamous intraepithelial lesions (LSILs) and high grade squamous intraepithelial lesion (HSIL) diagnoses when compared to the conventional smear. This increase was greater than twofold. The ASCUS:LSIL ratio was reduced by 55% in the ThinPrep group. Specimen adequacy was also improved: the ThinPrep method reduced the "satisfactory but limited by" (SBLB) rate by 35% and the "unsatisfactory" category by 73%. Limited biopsy results confirmed the increased sensitivity of ThinPrep.

CONCLUSION

In routine use in our laboratory, the ThinPrep method demonstrated a significant increase in the detection of LSIL and HSIL diagnoses. Specimen adequacy was also dramatically improved. The ThinPrep method significantly reduced the number of SBLB and unsatisfactory specimens.