Comparison of the Ames, Randox and Roche methods with the Synermed method for the determination of serum iron concentrations on nondialysis and dialysis specimens.

OBJECTIVES

To evaluate the Ames, Randox, Roche, and Synermed methods for the measurement of serum iron and to investigate patterns of possibly discrepant results in dialysis patients.

METHODS

Assays were performed on the Cobas Fara II analyzer. Precision and accuracy studies were conducted; recovery studies were done by adding pooled serum from dialysis patients to an assayed human serum-based control. Patient comparisons included over 150 nondialysis patients and 30 dialysis patients.

RESULTS

For the Ames, Randox, Roche and Synermed methods, the between-run precision was less than 2.80% with the normal aqueous iron standard; 2.00, 2.70, 0.80, and 2.00% for the four methods with the high serum iron control, respectively, and less than 2.30% with the serum pool. Using a pooled serum from dialysis patients, between-run precision was higher with all four methods. With an abnormal assayed human serum-based control, accuracy was over 98% for the four methods. Recoveries were 121% for the Ames and Randox methods and 104-105% for the Roche and Synermed methods. Accuracy as assessed with Murex EQAS specimens ranged from 71 to 80%, 71 to 96%, 98 to 99.5%, and 42 to 50% for the four methods, respectively. For comparisons of the Ames, Randox, and Roche methods with the Synermed method, difference analyses revealed biases (SD) for nondialysis patients of 1.9 (2.7), 1.5 (3.3), and 1.8 (2.2) mumol/L, respectively; and for dialysis patients of 8.2 (13.3), 5.1 (5.4), and 1.4 (1.7) mumol/L. Standard linear regression analyses and correlation coefficients are also provided.

CONCLUSIONS

The Roche method was slightly more precise than the other methods. Using an abnormal assayed serum-based control, all methods showed good accuracy. Recovery studies with pooled serum from dialysis patients showed interferences with the Ames and Randox methods and good recovery with the Roche and Synermed methods. With the bovine serum-based Murex samples, all but the Roche method yielded some low results; the Synermed method has been reported to suffer from matrix problems with bovine serum albumin. Based on recovery studies and difference analyses, the Ames and Randox methods revealed discrepancies in iron results for samples from dialysis patients. The Roche and Synermed methods appeared to be suitable for measurement of serum iron in dialysis patients.