Measurement uncertainty of test kit results--the ELISA example.
The measurement uncertainty budget for a clinical test-kit--an ELISA technique based on experimental data provided in the instruction manual--is presented. The proper characterization of the calibrators, within-plate homogeneity and the trueness of ELISA test-kits are identified as being major contributors to the combined uncertainty.
Suchanek
Miloslav
M
Institute of Chemical Technology, Prague, Czech Republic. miloslav.suchanek@vscht.cz
Robouch
Piotr
P
D000465:Algorithms; D002138:Calibration; D004797:Enzyme-Linked Immunosorbent Assay / Q000592:standards*; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D035501:Uncertainty
D011933:Reagent Kits, Diagnostic