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American Journal of Epidemiology Vol. 125, No. 4: 672-678
Copyright © 1987 by The Johns Hopkins University School of Hygiene and Public Health


research-article

COMPARING NEW AND OLD SCREENING TESTS WHEN A REFERENCE PROCEDURE CANNOT BE PERFORMED ON ALL SCREENEES

EXAMPLE OF AUTOMATED CYTOMETRY FOR EARLY DETECTION OF CERVICAL CANCER

ARTHUR SCHATZKIN, ROBERT J. CONNOR, PHILIP R. TAYLOR and BILL BUNNAG

Division of Cancer Prevention and Control, National Cancer Institute Bethesda, MD

Send reprint requests to Dr. Arthur Schatzkin, National Institutes of Health, National Cancer Institute, Blair Building, Room 6A01, 9000 Rockville Pike, Bethesda, MD 20892-4200

Direct determination of the sensitivity and specificity of a screening test requires use of a reference procedure (such as biopsy with histopathologic analysis) that provides an estimate of true disease status. The authors present a method for comparing the accuracy of a new screening test to an old one in situations when it is not feasible to apply the reference procedure to all screenees. This method requires that only those persons who test positive on old or new screening tests be further evaluated with the reference procedure. Ratios of sensitivities and specificities are derived for rapid comparison of the two screening tests. It is shown that McNemar's test can be used for significance testing of the differences in sensitivities and specificities between two screening tests. The required sample size for a study that compares the two tests is determined.

cervix neoplasms; cytological technics; flow cytometry; mass screening


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