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Appendix B. Automated Rescreening of Pap Smear Slides

As of December 1997, the U.S. Food and Drug Administration (FDA) had approved two techniques for automated computer-assisted evaluation of cervical cytology smears. These instruments are marketed as PAPNET Testing System (Neuromedical Systems, Inc., Suffern, NY) and AutoPap 300 QC System (Neopath, Inc., Redmond, WA). Neither is approved for use in initial interpretation of Pap smears; the FDA limits use of these instruments to rescreening of smears previously interpreted as negative. These automated screening methods, intended for quality control and adjunctive testing, could reduce laboratory false negatives due to human error, but they will not eliminate false negatives. Their drawbacks are limited availability, higher cost, and operators' limited experience using them in clinical settings. A laboratory that uses these instruments is not necessarily less likely to have a serious problem, since laboratory personnel still provide interpretation of Pap smear specimens. If computer-assisted methods are being considered for rescreening slides when a laboratory is closed, public health officials should obtain current FDA labeling of the equipment, current HCFA policies, and the views of relevant professional organizations regarding use of the equipment.



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