Comparison of the CytoRich system with conventional cervical cytology. Preliminary data on 2,032 cases from a clinical trial site.

OBJECTIVE

To compare the CytoRich system with conventional cervical cytology in a university medical center hospital laboratory.

STUDY

DESIGN

The CytoRich system combines liquid preservation, selective reduction of blood/inflammation, thin-layer preparation and discrete staining. Two thousand thirty-two parallel conventional and CytoRich samples were examined as part of a multicenter trial of the CytoRich/AutoCyte systems. Same-patient conventional and CytoRich slides were submitted to separate cytotechnologists blindly. The results were compared, and all nonmatching sample pairs were reviewed again. A consensus diagnosis was derived for all cases. The initial readings of the CytoRich and conventional smears were compared with each other and with the consensus diagnosis.

RESULTS

Of the 148 squamous intraepithelial lesions (SILs) found by either method, 85% were found by CytoRich, while only 58.5% were found by conventional smear. As compared with the consensus diagnosis, CytoRich slides had 86.7% sensitivity for SIL and 99.1% specificity, while the conventional slides had 63.6% sensitivity and 99.7% specificity. Consensus review resulted in upgrading to SIL in 1.8% of conventional slides and 1.4% of CytoRich slides. The biopsy correlation results were similar for the two methods.

CONCLUSION

The CytoRich system affords excellent cellular presentations and superior sensitivity for SILs when compared to the conventional technique.