CYTORICH LIQUID-BASED CERVICAL CYTOLOGIC TEST - SCREENING RESULTS IN A ROUTINE CYTOPATHOLOGY SERVICE

OBJECTIVE: To eliminate the disadvantages and inherent bias of split-s ample studies by evaluating the relative performance of monolayers and conventional cervical cytologic smears in a single laboratory through evaluation of two large and similar, randomly derived patient groups from the same geographical and demographically similar population. STU DY DESIGN: Two randomly created large patient groups from the same pop ulation were evaluated using conventional microscopic screening. One g roup was testing using the conventional smear. The other was evaluated using only the new liquid-preservative-based CytoRich preparation (Au toCyte, Inc., Elon College, North Carolina, U.S.A.) with the intended direct-to-vial cell collection method. Results were then compared stat istically as to disease detection and sample adequacy. RESULTS: Age co mparisons between the two groups demonstrated equivalency. Specimen ad equacy was greatly improved in the group tested with the CytoRich mono layer preparation. The monolayer group also demonstrated a significant reduction in ambiguous atypical squamous cells of undetermined signif icance/atypical glandular cells of undetermined significance diagnoses and a threefold increase in the detection of squamous intraepithelial lesion and cancer. CONCLUSION: Routine use of homogeneous monolayer p reparations as a total replacement for the conventional smear can be e xpected to dramatically improve specimen adequacy and sensitivity of t he conventional smear alone. Direct-to-vial use of the new monolayer p reparation generated significantly better results than those shown in any of the earlier split-sample trials.