Sphere Medical Limited, Harston Mill, Cambridge, CB22 7GG, UK.
J Clin Monit Comput. 2012 Feb;26(1):29-36. doi: 10.1007/s10877-011-9330-0. Epub 2012 Jan 1.
The authors evaluated an analyser for the determination of propofol concentrations in whole blood. The Pelorus 1000 (Sphere Medical) measures propofol concentrations in around 5 min without the requirement for sample preparation. The performance of the analyser was characterised with respect to linearity, precision in control solutions and whole blood and method comparison to an HPLC based reference method. In addition, the effects of substances considered to potentially affect the assay method were investigated. The analyser was found to be linear up to 12 μg/ml (R2 = 0.9993), with a lower limit of quantification of 0.75 μg/ml. Total within device imprecision in control solutions was 0.11 μg/ml at 5.32 μg/ml and 0.17 μg/ml at 10.3 μg/ml. Within run precision in whole blood was 0.04 μg/ml at 2.84 μg/ml and 0.08 μg/ml at 6.68 μg/ml and for the reference method was 0.06 μg/ml and 0.12 μg/ml respectively. In comparison to the reference method, the overall bias of the Pelorus 1000 system over the range is estimated to be 0.15 μg/ml (95% confidence interval -0.11-0.41 μg/ml). The only cross interference of note is to a highly elevated level of conjugated bilirubin, while low haematocrit levels lead to a 0.13 μg/ml under reading with respect to the HPLC reference. The system fulfils the requirements for measurement of propofol concentrations in whole blood samples with precision and accuracy suitable for elucidating propofol pharmacokinetics at clinically relevant concentrations. With no requirement for sample preparation and a fast time to results, the analyser opens up the possibility of studies to measure and respond to blood propofol concentrations in patients in close to real time.
作者评估了一种用于测定全血中丙泊酚浓度的分析仪。Pelorus 1000（Sphere Medical）可在无需样品制备的情况下，在大约 5 分钟内测量丙泊酚浓度。该分析仪的性能通过线性、在控制溶液和全血中的精密度以及与基于 HPLC 的参考方法的方法比较来进行评估。此外，还研究了可能影响测定方法的物质的影响。该分析仪在线性范围内的上限为 12 μg/ml（R2 = 0.9993），定量下限为 0.75 μg/ml。在 5.32 μg/ml 和 10.3 μg/ml 时，控制溶液中的总仪器内精密度为 0.11 μg/ml；在 2.84 μg/ml 和 6.68 μg/ml 时，全血中的批内精密度为 0.04 μg/ml，参考方法的精密度分别为 0.06 μg/ml 和 0.12 μg/ml。与参考方法相比，Pelorus 1000 系统在整个范围内的总体偏差估计为 0.15 μg/ml（95%置信区间 -0.11-0.41 μg/ml）。唯一值得注意的交叉干扰是高度升高的结合胆红素水平，而低红细胞压积水平相对于 HPLC 参考值会导致读数低 0.13 μg/ml。该系统满足在临床相关浓度下阐明丙泊酚药代动力学所需的全血样本中丙泊酚浓度的测量精度和准确性要求。由于无需样品制备且分析速度快，该分析仪为在接近实时的情况下测量和响应患者血液丙泊酚浓度的研究开辟了可能性。
