Effect of Hemopure® on the Performance of Ektachem and Hitachi Clinical Analyzers

Abstract

Hemopure®, an ultrapurified polymerized hemoglobin-based oxygen-carrying solution, is currently undergoing evaluation in elective surgery patients (1). This experimental drug may obscure routine clinical chemistry assays because it is naturally pigmented and circulates in the plasma (2). Because chemistry analyzers use colorimetric methods for many of their tests, the presence of Hemopure in a sample may cause interference in the assay, depending upon the instrument used, the methodology, and the reagents. To obtain accurate chemistry results for both the clinical study and for patient management, it was necessary to determine the extent of these interferences. At each clinical trial site, the chemistry analyzers were challenged with samples containing Hemopure up to 50 g/L to determine the maximum amount of Hemopure that may be present in a sample to obtain accurate results for each test. Hitachi (Boehringer Mannheim Diagnostics) and Ektachem/Vitros …