Specimen adequacy of ThinPrep sample preparations in a direct-to-vial study

Abstract

Objective: To assess specimen adequacy of the ThinPrep slide preparation method in routine use.

Study design: Two studies, a feasibility study of 299 women and a clinical study of 499 women, were conducted. A broom-type collection device was used and rinsed directly into Pre-servCyt vials. Slides were prepared with the ThinPrep 2000 device, screened and classified according to the Bethesda System. The proportion of ThinPrep slides described as "Satisfactory But Limited By: No Endocervical Component (SBLB:No ECC)" was then compared to the proportion of SBLB: No ECC slides found on conventional smears in a previously conducted clinical trial of over 7,000 patients.

Results: For the feasibility study the proportion of ThinPrep slides described as SBLB: No ECC was 9.36% as compared to the clinical trial combined rate of 9.4% for conventional smears. For the clinical study, 4.96% of ThinPrep slides were SBLB:No ECC as compared to the 4.4% SBLB:No ECC rate for conventional smears from the same clinical trial. The proportions were statistically equivalent for both studies.

Conclusion: It is expected that the rate of representing endocervical component will be maintained when the ThinPrep preparation method is used routinely in place of the conventional cytologic smear method.