Biedler A, Risch A, Mertzlufft F
Klinik für Anaesthesiologie und Intensivmedizin, Universitätskliniken des Saarlandes.
Anaesthesist. 1998 Dec;47(12):968-74. doi: 10.1007/s001010050653.
The introduction of biosensor technology for near bedside measurement of plasma lactate concentrations has been a promising step for critical care profiling. However, methodological drawbacks and relevant inaccuracy have been reported. With the advent of a new biosensor (Chiron Diagnostics) and a revised NOVA Biomedical device, accuracy was expected to be improved. The goal of the present investigation was to evaluate the accuracy of both methods.
Two devices (System 860, Chiron Diagnostics; StatProfile 9, NOVA Biomedical) were simultaneously analysed using 9 biosensors in both fresh frozen plasma and citrated whole blood. The results were compared with an established photometric method (Lactat PAP, Analyticon). Measurements were performed as duplicates (n = 1120) before and after the addition of 1 molar sodium lactate solution (2-24 mmol/L). For the estimation of between-day precision commercially available aqueous and serum-based quality controls were analysed daily over a period of 60 days.
Reproducibility in blood was 2.6 +/- 2.8% (Chiron), 4.1 +/- 4.0% (NOVA) and 1.5 +/- 2.1% (Analyticon), in plasma respectively 2.1 +/- 2.4%, 2.1 +/- 2.9% and 1.0 +/- 1.1%. Mean inaccuracy in plasma presented to be -0.2 +/- 16.4% (plasma) and +7.2 +/- 13.1% (blood) for Chiron, +9.4 +/- 18.4% and +18.7 +/- 16.7% for NOVA, and -37.8 +/- 18.2% and -27.5 +/- 17.6% for Analyticon. Calculated between-day-precision (variation coefficients mean values) was 11.5 +/- 4.9% (Chiron) and 14.0 +/- 5.9% (NOVA).
Although accuracy of lactate concentrations obtained with biosensor technology has improved (mean 0-18%), the variability of the results still poses a problem (mean 13-18%). Therefore, from the methodological point of view, interpretation of a single lactate value requires caution when applying to the critically ill, particularly with view to threshold values, and should be considered vis-à-vis other options.
用于床旁测量血浆乳酸浓度的生物传感器技术的引入，是危重症病情分析中很有前景的一步。然而，已有报道指出该方法存在缺陷和相关不准确之处。随着新型生物传感器（Chiron诊断公司）和经修订的诺华生物医学设备的出现，预计准确性会有所提高。本研究的目的是评估这两种方法的准确性。
使用9个生物传感器，在新鲜冷冻血浆和枸橼酸盐抗凝全血中同时分析两种设备（860系统，Chiron诊断公司；StatProfile 9，诺华生物医学）。将结果与既定的光度法（Lactat PAP，Analyticon）进行比较。在添加1摩尔乳酸钠溶液（2 - 24 mmol/L）之前和之后，测量重复进行（n = 1120）。为评估日间精密度，在60天内每天分析市售的水性和血清基质质量控制品。
血液中的重现性分别为2.6 ± 2.8%（Chiron）、4.1 ± 4.0%（诺华）和1.5 ± 2.1%（Analyticon），血浆中分别为2.1 ± 2.4%、2.1 ± 2.9%和1.0 ± 1.1%。Chiron在血浆中的平均误差为 -0.2 ± 16.4%（血浆）和 +7.2 ± 13.1%（血液），诺华为 +9.4 ± 18.4%和 +18.7 ± 16.7%，Analyticon为 -37.8 ± 18.2%和 -27.5 ± 17.6%。计算得出的日间精密度（变异系数平均值）为11.5 ± 4.9%（Chiron）和14.0 ± 5.9%（诺华）。
尽管生物传感器技术获得的乳酸浓度准确性有所提高（平均0 - 18%），但结果的变异性仍然是个问题（平均13 - 18%）。因此，从方法学角度来看，在应用于危重症患者时，对单个乳酸值的解读需要谨慎，尤其是对于阈值，并且应与其他方法进行对比考虑。
