Objective evaluation of data in screening for disease.
BACKGROUND
In order to decide on the feasibility of screening for disease by laboratory testing, a number of assessments need to be made. The necessary procedures and statistical calculations are required for an objective evaluation of the diagnostic accuracy of a laboratory test and of the potential for screening and of the data obtained from the screening.


METHODS
The determination of reference intervals, is an essential first step in the evaluation of the performance of a laboratory test. The procedures and calculations are necessary for the determination of the sensitivity, specificity, diagnostic predictive value and receiver-operating characteristic curve of a test and their respective applications in laboratory screening for disease. The additional statistical tools include odds ratios and likelihood ratios for assessing the performance of a laboratory test.


CONCLUSIONS
These tools are used in the development of an appropriate clinical decision limit in a defined population of subjects and under defined conditions for acceptable screening.
Sasse
Edward A
EA
Clement J. Zablocki VA Medical Center, 5000 W. National Avenue, Milwaukee, WI 53295, USA. esasse@wi.rr.com
D019411:Clinical Laboratory Techniques; D003657:Decision Making; D006801:Humans; D009098:Multiphasic Screening / Q000379:methods* / Q000639:trends; D016017:Odds Ratio; D011237:Predictive Value of Tests; D012372:ROC Curve; D012016:Reference Values; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity