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学科主题: 临床医学
题名:
Evaluation of four commercial biuret reagent kits of serum total protein by the American Association for Clinical Chemistry reference measurement procedure
作者: He, Meilin; Zhang, Jie
关键词: biuret reaction ; method evaluation ; reference measurement procedure ; serum total protein
刊名: CLINICAL CHEMISTRY AND LABORATORY MEDICINE
发表日期: 2011-06-01
DOI: 10.1515/CCLM.2011.153
卷: 49, 期:6, 页:989-992
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Medical Laboratory Technology
研究领域[WOS]: Medical Laboratory Technology
英文摘要:

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.

语种: 英语
所属项目编号: 2007BAI05B09
项目资助者: National Key Technology RD Program
WOS记录号: WOS:000291429500008
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/59009
Appears in Collections:北京大学第三临床医学院_期刊论文

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作者单位: Peking Univ, Hosp 3, Dept Lab Med, Beijing 100191, Peoples R China

Recommended Citation:
He, Meilin,Zhang, Jie. Evaluation of four commercial biuret reagent kits of serum total protein by the American Association for Clinical Chemistry reference measurement procedure[J]. CLINICAL CHEMISTRY AND LABORATORY MEDICINE,2011,49(6):989-992.
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