Biomaterial Database

Accuracy of in vivo and in vitro tests. 1998

C Bindslev-Jensen, and L K Poulsen

Department of Dermatology, Odense University Hospital, Denmark.

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.

UI	MeSH Term	Description	Entries
D007223	Infant	A child between 1 and 23 months of age.	Infants
D002986	Clinical Trials as Topic	Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.	Clinical Trial as Topic
D003429	Cross Reactions	Serological reactions in which an antiserum against one antigen reacts with a non-identical but closely related antigen.	Cross Reaction,Reaction, Cross,Reactions, Cross
D004311	Double-Blind Method	A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.	Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005512	Food Hypersensitivity	Gastrointestinal disturbances, skin eruptions, or shock due to allergic reactions to allergens in food.	Allergy, Food,Food Allergy,Hypersensitivity, Food,Allergies, Food,Food Allergies,Food Hypersensitivities,Hypersensitivities, Food
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000485	Allergens	Antigen-type substances that produce immediate hypersensitivity (HYPERSENSITIVITY, IMMEDIATE).	Allergen
D012882	Skin Tests	Epicutaneous or intradermal application of a sensitizer for demonstration of either delayed or immediate hypersensitivity. Used in diagnosis of hypersensitivity or as a test for cellular immunity.	Skin Test,Test, Skin,Tests, Skin