OBJECTIVE: This study assessed the usefulness of the AutoPap 300 QC System in identifying of detection false negative(DFN) smears in a slide population previously screened as "within normal limits" and compared the rate of identification of DFN to that using 10% random selection. MATERIALS AND METHODS: From December 1996 to August 1998, we utilized the AutoPap 300 QC System at 30% selection rate to select cases for manual review. During the study period, 1,040(83.4%) among 1,247 smears and 7,848(84.0%) among 9,343 smears were screened as "within normal limits" and were included for the AutoPap 300 QC System and 10% random selection studies, respectively. RESULTS: 357(34.3%) among 1,040 were selected by the AutoPap 300 QC System at 30% QC selection rate and reviewed manually. Overall, 63 among 357 were determined to be abnormal including 47 ASCUS, 2 AGUS, and 14 LSIL. 785(10%) among 7,848 were selected by 10% random selection and reviewed manually. 96 among 785 were determined to be abnormal including 69 ASCUS, 3 AGUS, and 24 LSIL. These results represented an increase in pick up rate of DFN(detection false negative) of 5.1 and 4.4 fold for ASCUS/AGUS and LSIL, respectively and of 1.5 and 1.3 fold when accounting for the volume differences measured. CONCLUSIONS: The study demonstrated that the AutoPap 300 QC System is superior to 10% human random screening for the identification of DFN smears. Further studies are required using variable selection rates and a larger number of smears to fully assess the value of the device in quality control mode.
Humans ; Mass Screening ; Quality Control ; Vaginal Smears

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Diagnosis*

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Diagnosis*

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