Sachs C, Finetti P, Rabouine P, Abdoulaye F
Département de physiologie, CHU Necker-Enfants malades et Hôpital Laennec, Paris.
Ann Biol Clin (Paris). 2002 Jul-Aug;60(4):411-20.
Aware of some limitations on blood gas results, we performed an extensive evaluation before introducing i-STATs in our hospitals. Three i-STATs were tested in parallel with an ABL-520, on three types of cartridges (EG7, EG6 and EG3), using tonometered whole blood (9 gas levels, n = 720) and aqueous QC solutions (3 levels, n = 600). Reference systems were the theoretical calculated values from gas composition used for tonometry and results given by the ABL-520, respectively. On aqueous controls dispersion intervals reached 10-20 mmHg for both analytes for inter-lot as well as intra-lot data. PO2 values on blood showed marked dispersion: 5 mmHg (CV = 2 to 7%) at clinically critical levels. PCO2 showed several (10%) major outliers: mV recording of the PCO2 electrode allowed to incriminate a pre-humidification problem (due to incorrect shipping conditions). Once outliers have been discarted, there still was a 5 mmHg non negligible residual dispersion (CV = 3 to 5%). i-STAT analytical performances for blood gases which are the analytes whose determination at the bed-side is potentially the most useful, do not match capabilities of classical laboratory instruments. Thus even though the i-STAT approach represents a seducive solution for the STAT problem, for the moment, it's use cannot be recommended in a hospital environment where classical instruments can be made available.
鉴于血气分析结果存在一些局限性,我们在医院引入i-STAT分析仪之前进行了广泛评估。使用校准过的全血(9种气体水平,n = 720)和水性质量控制溶液(3种水平,n = 600),在三种类型的试剂盒(EG7、EG6和EG3)上,将三台i-STAT分析仪与一台ABL-520分析仪进行平行测试。参考系统分别是用于校准的气体成分的理论计算值和ABL-520给出的结果。在水性对照中,批间和批内数据的两种分析物的离散区间均达到10 - 20 mmHg。血液中的PO2值显示出明显的离散:在临床临界水平时为5 mmHg(CV = 2%至7%)。PCO2显示有几个(10%)主要异常值:PCO2电极的mV记录显示存在预加湿问题(由于运输条件不正确)。一旦剔除异常值,仍存在5 mmHg的不可忽略的残余离散(CV = 3%至5%)。对于血气分析(其在床边的测定可能是最有用的分析物),i-STAT分析仪的分析性能与传统实验室仪器的能力不匹配。因此,尽管i-STAT方法对于即时检验问题是一种诱人的解决方案,但目前,在可以使用传统仪器的医院环境中,不建议使用它。