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Study of the correlation between MEIA and ELISA methods for FK 506 determination in liver transplant recipients
E Rudant1, Y Bezie, L Bonhomme-Faivre
1Laboratoire de pharmacocinétique, Service de Pharmacie, Couturier, Villejuif, France.
Background And Objectives:
FK 506 is an immunosuppressive macrolide advocated for prevention of graft rejection. Plasma or blood FK 506 levels must be determined to strike a balance between FK 506 toxicity and graft rejection. The first aim of this study was to compare an automated microparticle enzyme immunosorbent assay (MEIA) method (on whole blood) with the reference enzyme-linked immunosorbent assay (ELISA) method (on plasma). A second aim was to compare the two methods for prediction of FK 506 nephrotoxicity.
Patients And Methods:
Forty-seven patients were studied comprising 128 samples. All were treated with FK 506 on a compassionate basis. For each patient, the concentrations of FK 506 were determined in plasma by means of ELISA and in whole blood by MEIA.
Results:
The repeatability and the reproducibility of these two methods were similar. The inter-patient correlation coefficient between MEIA and ELISA, determined on 128 samples from 47 liver recipients, was satisfactory (r = 0.82). From these 47 patients, the intra-patient correlation coefficients were calculated for 17 of them. The intra-patient correlation coefficients were between 0.63 and 0.98 for 15 patients, and between 0.26 and 0.55 in the remaining two cases. Mean creatinine plasma levels in the 55 samples below the median FK 506 value in the MEIA method and in the 55 with values above the median (120 and 134 mumol/litre, respectively) were significantly different (P < 0.05), as were those using the reference ELISA methods (115 and 139 mumol/litre, P < 0.01). In contrast, there was no significant difference between the mean creatinine plasma levels in the 55 samples with FK 506 levels below the median using both methods or between those above the median.
Conclusion:
The automated MEIA method, being simpler and more rapid than the ELISA method, should now be preferred for therapeutic monitoring of FK 506.
Insights
The automated microparticle enzyme immunosorbent assay (MEIA) is a reliable and faster method for monitoring FK 506 levels in whole blood compared to plasma enzyme-linked immunosorbent assay (ELISA). This method aids in predicting FK 506-induced nephrotoxicity.
Area of Science:
- Pharmacology
- Clinical Chemistry
- Transplantation Medicine
Background:
- FK 506 (tacrolimus) is a crucial immunosuppressant for preventing organ graft rejection.
- Therapeutic drug monitoring of FK 506 is essential to balance efficacy and toxicity.
- Accurate FK 506 quantification is needed to guide treatment decisions.
Purpose of the Study:
- To compare the performance of an automated microparticle enzyme immunosorbent assay (MEIA) using whole blood with the reference enzyme-linked immunosorbent assay (ELISA) using plasma for FK 506 measurement.
- To evaluate the utility of both MEIA and ELISA methods in predicting FK 506-associated nephrotoxicity.
Main Methods:
- A comparative study involving 128 samples from 47 patients receiving FK 506 for graft rejection prevention.
- FK 506 concentrations were determined in whole blood using MEIA and in plasma using ELISA.
- Correlation analysis and assessment of creatinine levels were performed to evaluate method agreement and predictive value for nephrotoxicity.
Main Results:
- Both MEIA and ELISA demonstrated similar repeatability and reproducibility.
- A satisfactory inter-patient correlation (r = 0.82) was observed between MEIA and ELISA.
- MEIA and ELISA methods both showed significant differences in mean creatinine levels between samples below and above the median FK 506 concentrations, indicating predictive potential for nephrotoxicity.
Conclusions:
- The automated MEIA method offers a simpler and faster alternative to ELISA for therapeutic drug monitoring of FK 506.
- MEIA is suitable for routine clinical use due to its efficiency and comparable accuracy.
- Both methods effectively correlate FK 506 levels with the risk of nephrotoxicity.