Accuracy of in vivo and in vitro tests

Any new diagnostic test should be validated by standard procedures, and must be validated by the outcome of double-blind, placebo-controlled food challenges (DBPCFC), except in infants, with strict adherence to the EAACI guidelines. Available data should include calculations on sensitivity, specificity, predictive values, and concordance and must be calculated on the basis of patients in whom the diagnosis has been established by DBPCFC. Furthermore, data on possible cross-reacting foods and their clinical relevance should be available. (C) Munksgaard 1998.