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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