An evaluation of an enzyme immunoassay method for immunoreactive trypsin in dried blood spots.

A novel monoclonal antibody based enzyme immunoassay (EIA) method for the measurement of the human cationic trypsinogen (NeoScreen, AGEN Biomedical Ltd., Acacia Ridge, Australia) in dried blood spots for the neonatal screening of cystic fibrosis was evaluated. The calibration standards provided as dried blood spots by AGEN are highly unstable and must be replaced with user prepared materials. Reference values from control individuals were obtained by parametric methods. A preliminary comparison with a polyclonal antibody based RIA method (Trypsik, SORIN Biomedica, Saluggia, Italy) was performed. Regression analysis between the RIA and the EIA methods gave a coefficient of correlation of 0.58 for RIA values less than 40 micrograms/L and of 0.77 for RIA values greater than or equal to 40 micrograms/L. Average CV of the within-run imprecision for the EIA method was 19.6% and for the RIA method 28.8%. CVs of the between-run imprecision at low, intermediate and high values for the EIA method were 23.7%, 15.8%, 15.6% and for the RIA method 20.6%, 14.4%, 11.2%. The diagnostic accuracy analyzed by a Receiver Operating Characteristics (ROC) curve of the RIA method gave a maximum accuracy of 190.9 while that of a simulated ROC curve for the EIA method was 193.0. We found that the precision and the diagnostic accuracy of the EIA method (AGEN) are equal to or better than those of one of the RIA methods.