Evaluation of four commercial biuret reagent kits of serum total protein by the American Association for Clinical Chemistry reference measurement procedure

Meilin He; Jie Zhang

doi:10.1515/CCLM.2011.153

Article

Evaluation of four commercial biuret reagent kits of serum total protein by the American Association for Clinical Chemistry reference measurement procedure

Meilin He and Jie Zhang

Published/Copyright: March 11, 2011

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From the journal Clinical Chemistry and Laboratory Medicine Volume 49 Issue 6

Abstract

Background: In China, the traceability of clinical chemistry methods is still immature. Therefore, it is necessary to establish a reference measurement procedure and evaluate commercial reagent kits using such established procedures.

Methods: We reproduced the reference measurement procedure for serum total protein, as recommended by the American Association for Clinical Chemistry (AACC). We evaluated the performance by Clinical Laboratory Standard Institute (CLSI) guidelines EP15-A and EP6-A. Subsequently, four commercial reagent kits were evaluated by the reproduced reference procedure following CLSI guideline EP9-A2.

Results: The performance of the reproduced reference procedure was as follows: CVs ranged from 0.47% to 0.85% at medical decision levels (X_c) of 45 g/L, 60 g/L and 80 g/L. Linearity was Y=1.0022X–0.2121 (r=0.9999), and recovery ranged from 100.2% to 102.4%. The External Quality Assessment Scheme for Reference Laboratories in Laboratory Medicine (RELA) was applied, and the result was within the limit of equivalence. The linear relationships of four commercial reagent kits, Merit Choice, KHB, Leadman, and Olympus, were, respectively: Y=0.9922X+0.5776 (r=0.9961); Y=0.9936X+0.4316 (r=0.9992); Y=0.9949X+0.9129 (r=0.9987) and Y=0.9923X+0.8876 (r=0.9989). KHB showed slight negative bias, and the mean±SD was –0.03±0.60 g/L. Merit Choice, Leadman, and Olympus all showed positive bias, and the mean±SDs were 0.02±0.63 g/L, 0.55±0.77 g/L and 0.34±0.71 g/L, respectively.

Conclusions: The correlation and bias of four commercial reagent kits for serum total protein were found to be acceptable. Thus, these reagent kits can be used reliably in China.

Keywords: biuret reaction; method evaluation; reference measurement procedure; serum total protein

Corresponding author: Dr. Jie Zhang, Department of Laboratory Medicine, Peking University Third Hospital, 100191 Beijing, P.R. China Phone/Fax: +86-10-82265719

Received: 2010-11-2

Accepted: 2011-1-6

Published Online: 2011-03-11

Published in Print: 2011-06-01

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https://doi.org/10.1515/CCLM.2011.153

Keywords for this article

biuret reaction; method evaluation; reference measurement procedure; serum total protein