Analytical Performance Evaluation of ADVIA Chemistry Carbamazepine_2 Assay: Minimal Cross-Reactivity With Carbamazepine 10, 11-Epoxide and None With Hydroxyzine or Cetirizine

作者：Dasgupta Amitava^*; Reyes Meredith A; Davis Barbara G; Marlow Anne M; Johnson Myrtle

来源：Journal of Clinical Laboratory Analysis, 2010, 24(4): 278-282.

DOI：10.1002/jcla.20400

• carbamazepine
• immunoassays
• carbamazepine 10, 11-epoxide
• interference

Carbamazepine is an anticonvulsant requiring routine therapeutic drug monitoring. Recently, Siemens Healthcare Diagnostic Division released a new carbamazepine assay: ADVIA Chemistry Carbamazepine_2 (Carbamazepine_2) for application on ADVIA analyzers. We evaluated the analytical performance of this assay as well as its potential cross-reactivities with carbamazepine 10, 11-epoxide, hydroxyzine, and cetirizine. The within-run and between-run precisions of the Carbamzepine-2 assay were <6% and limit of detection was 0.5 mu g/ml using ADVIA 1800 analyzer. The assay was linear up to a carbamazepine concentration of 20.0 mu g/ml. The new method compared well with a widely used carbamazepine EMIT 2000 assay on the Hitachi 917 analyzer. Using 75 patients' specimens (where carbamazepine concentrations varied from 0.5 to 21.7 mu g/ml) and carbamazepine EMIT 2000 as the reference method (x-axis), we observed the following regression equation: y=1.04 x+0.32 (r=0.99). The new carbazepine_2 method was not affected by a hemoglobin concentration of 1,000 mg/dl, conjugated or unconjugated bilirubin concentration of 60 mg/dl, and triglyceride concentration of 1,000 mg/dl. In addition, this assay showed no cross-reactivity with hydroxyzine or cetirizine and demonstrated minimal cross-reactivity with carbamazepine 10, 11-epoxide. We conclude that the ADVIA Chemistry carbamazepine_2 assay has adequate precision and accuracy for routine therapeutic drug monitoring of carbamazepine in clinical laboratories. J. Clin. Lab. Anal. 24:278-282, 2010.

• 出版日期2010