Clinical trials of the CytoRich specimen-preparation device for cervical cytology. Preliminary results.

OBJECTIVE

To obtain preliminary data on the Roche CytoRich thin-layer system for the preparation of gynecologic cytology specimens, derived from a preclinical startup evaluation of the instrument and comparing the CytoRich method to conventional smears.

STUDY DESIGN

At six different clinical sites, 286 pairs of conventional and CytoRich slides derived from the same patient sample were compared for the following: final Bethesda classification diagnosis, specimen adequacy and presence of microorganisms.

RESULTS

The study showed agreement between the methods for an exact Bethesda diagnosis in 78% and agreement within one Bethesda diagnosis category in 95%. The CytoRich method diagnosed more cases of squamous intraepithelial lesion (SIL) than did the conventional method, and the differences in SIL detection were statistically significant. The CytoRich method identified similar numbers of cases with microorganisms as did the conventional smears, and the CytoRich system improved overall specimen adequacy as compared to the conventional method, with fewer cases of unsatisfactory and less-than-optimal smears.

CONCLUSION

The CytoRich method may improve the overall sensitivity and specificity of the cervical cytology procedure. Clinical trials to verify these preliminary data are ongoing.