Lindemans J, Hoefkens P, van Kessel A L, Bonnay M, Külpmann W R, van Suijlen J D
Department of Clinical Chemistry, University Hospital Rotterdam, 3000 CA Rotterdam, The
Clin Chem. 1999 Jan;45(1):111-7.
A recently introduced blood gas/electrolyte analyzer (SenDx 100((R)), renamed ABL70) intended for point-of-care, near-patient, or stat laboratory use was evaluated simultaneously in four different institutions and compared with three different laboratory bench analyzers with respect to imprecision, inaccuracy (assessed by tonometry), and patient-sample analyses. The analyzer is equipped with a sensor cassette and a reagent cartridge for 50, 100, or 200 analyses and 100 or more traditional quality-control measurements. One analysis requires 170 microL of whole blood and takes <90 s. Statistically, the instrument performed somewhat better (lower CVs) for PO2 and potassium and somewhat worse for pH, PCO2, and ionized calcium than the respective comparison analyzers. However, the overall performance (in terms of CV and accuracy) was satisfactory in terms of clinical (e.g., CLIA '88) goals in all institutions. The mean difference and the CV of that difference in some 400 patient-sample comparisons were as follows: 0.010 (+/- 0.002%) for pH, -0.65 mmHg (+/- 4%) for PCO2, -0.49 mmHg (+/- 6%) for Po2, 0.44 mmol/L (+/- 1.2%) for sodium, -0.013 mmol/L (+/- 2.9%) for potassium, -0.016 mmol/L (+/- 2.6%) for ionized calcium, and -0.016 L/L (+/- 7. 1%) for the hematocrit. Its acceptable analytical performance and ease of operation make the SenDx 100 suitable for the analysis of blood gases and electrolytes.
一种最近推出的用于即时检测、床旁检测或急诊实验室检测的血气/电解质分析仪(SenDx 100((R)),后更名为ABL70)在四个不同机构同时进行了评估,并与三种不同的实验室台式分析仪在精密度、不准确性(通过压力计评估)和患者样本分析方面进行了比较。该分析仪配备了一个传感器盒和一个试剂盒,可进行50次、100次或200次分析以及100次或更多传统质量控制测量。一次分析需要170微升全血,耗时不到90秒。从统计学角度来看,与各自的比较分析仪相比,该仪器在测定氧分压(PO2)和钾时表现稍好(变异系数较低),而在测定pH值、二氧化碳分压(PCO2)和离子钙时表现稍差。然而,就所有机构的临床(如1988年临床实验室改进修正案(CLIA '88))目标而言,其总体性能(就变异系数和准确性而言)是令人满意的。在约400次患者样本比较中,平均差异及其变异系数如下:pH值为0.010(±0.002%),PCO2为 -0.65毫米汞柱(±4%),PO2为 -0.49毫米汞柱(±6%),钠为0.44毫摩尔/升(±1.2%),钾为 -0.013毫摩尔/升(±2.9%),离子钙为 -0.016毫摩尔/升(±2.6%),血细胞比容为 -0.016升/升(±7.1%)。其可接受的分析性能和操作简便性使SenDx 100适用于血气和电解质分析。