A. Weyer et al., INTERPRETATION OF LABORATORY ASSAYS - CRI TERIA TO BE DEFINED FOR RESEARCH OBJECTIVES OR FOR CLINICAL-DIAGNOSIS - APPLICATIONS IN ALLERGOLOGY, Revue francaise d'allergologie et d'immunologie clinique, 37(7), 1997, pp. 819-826
Based on the experimental results obtained in allergology, the authors
define the experimental strategy to be used when studying a possible
relationship between clinical symptoms and a measurable laboratory par
ameter (laboratory test), or when evaluating whether this laboratory t
est can be performed for diagnostic purposes. In the first case, compa
risons of the mean values corresponding to various groups of individua
ls provide answers to questions concerning the relationship between a
type of disease and the experimental value of the parameters measured;
these analyses can then be completed by correlation studies. In the s
econd case, the criteria considered to be essential to validate a labo
ratory test in relation to a clinical diagnosis are defined, especiall
y sensitivity and specificity. On the basis of these two criteria, est
ablished by the study of clearly defined populations (patients and con
trols), the negative and positive predictive values can be calculated
by taking into account the prevalence of the disease. The result of a
laboratory test for an individual belonging to a representative patien
t sample can then be interpreted as being normal or pathological accor
ding to its situation in relation of these reference normal values.