No 09+10/2003 » Abstract

More on the Reliability of the Microparticle Enzyme Imrnunoassay (MEIA) forTherapeutic Tacrolimus Monitoring

by Jesus Hermida and J. Carlos Tutor

Recently, the validity of determining tacrolimus concentrations in blood samples using Abbott’s microparticle enzyme immunoassay (MEIA) has been seriously questioned. This communication presents the results obtained in our laboratory using the MEIA for 31 pooled blood samples from kidney and liver transplant patients (Tacrolimus International Proficiency Testing Scheme). A good correlation was found with regard to the average of the MEIA method (r=0.950) without reaching clinical significance for the difference between the means (9.54 ng/ml vs 9.74 ng/ml), although the standard error of the estimate (Syx= 0.66 ng/ml) was clinically significant. With regard to the average values for HPLC-methods, a lower correlation coefficient was found (r=0.819), with a difference between the means (9.54 ng/ml vs 8.91 ng/ml) slightly greater than the clinically acceptable value, and a clinically significant standard error of the estimate (Syx=1.22 ng/ml). In the case of the correlation between the average values for the MEIA and HPLC methods, a higher correlation coefficient was found (r=0.918), with a difference between the means (9.74 ng/ml vs 8.91 ng/ml) and a standard error of the estimate (Syx=0.75 ng/ml) being clinically significant. However, these differences were lesser than 15% of HPLC results in accordance with the American Association of Pharmaceutical Scientists acceptance criteria for analytical methods employed for quantification of drugs and their metabolites.

Clin. Lab. 2003;49(9-10):471.

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