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化学1分析仪的评估

Evaluation of the Chem 1 analyzer.

作者信息

Biosca C, Antoja F, Sierra C, Aluma A, Farre J, Alsina M J, Galimany R

机构信息

Servei d'Analisis Clíniques, Hospital Germans Trías i Pujol, Barcelona, Spain.

出版信息

Ann Biol Clin (Paris). 1991;49(4):208-13.

PMID:1928836
Abstract

The selective multitest Technicon Chem 1 analyser was evaluated according to the guidelines of the 'Comisión de Instrumentación de la Sociedad Española de Química Clínica', and the protocols of the 'European Committee for Clinical Laboratory Standards' and 'Commission de validation de techniques' of the 'Société Française de Biologie Clinique'. The evaluation was performed in three steps: evaluation in routine conditions, assessment of the interferences and study of practicability. Under routine working conditions, eighteen constituents were studied. Within-run imprecision ranged from 0.6% (CV) for gamma-GT to 4.7% (CV) for AST. Between-run imprecision ranged from 1.6% (CV) for ion sodium to 5.5% (CV) for creatinine. Specimen related carry-over was not within the samples; specimen independent carry-over was found in some of the constituents studied. The relative inaccuracy is good for all the constituents assayed. Haemoglobin (290 mumol.l1) showed a positive interference with urate at three concentration levels (low, medium and high). Bilirubin (up to 300 mumol.l-1) caused a negative interference with creatinine at three concentration levels. Turbidity (trigliceride up to 4 mumol.l-1) stated a positive interference with creatinine at three concentration levels and with AST at two concentration levels (low and medium). Turbidity also caused a negative interference with urate at three concentration levels and with urea at two concentration levels (low and medium).

摘要

根据“西班牙临床化学学会仪器委员会”的指南以及“欧洲临床实验室标准委员会”和“法国临床生物学协会‘技术验证委员会’”的方案,对选择性多检测Technicon Chem 1分析仪进行了评估。评估分三个步骤进行:常规条件下的评估、干扰评估和实用性研究。在常规工作条件下,对18种成分进行了研究。批内不精密度范围为γ-谷氨酰转移酶的0.6%(变异系数)至天冬氨酸转氨酶的4.7%(变异系数)。批间不精密度范围为离子钠的1.6%(变异系数)至肌酐的5.5%(变异系数)。样本相关携带污染不在样本范围内;在一些研究的成分中发现了样本独立携带污染。所有测定成分的相对误差均良好。血红蛋白(290 μmol·l⁻¹)在三个浓度水平(低、中、高)对尿酸盐显示出正干扰。胆红素(高达300 μmol·l⁻¹)在三个浓度水平对肌酐产生负干扰。浊度(甘油三酯高达4 μmol·l⁻¹)在三个浓度水平对肌酐以及在两个浓度水平(低和中)对天冬氨酸转氨酶显示出正干扰。浊度在三个浓度水平对尿酸盐以及在两个浓度水平(低和中)对尿素也产生负干扰。

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