Wilson J F, Marshall R W, Williams J, Richens A
Ther Drug Monit. 1984;6(2):243-50. doi: 10.1097/00007691-198406000-00020.
The accuracy and precision of gas-liquid chromatography with and without derivatization (GLC + D, GLC-ND), high-pressure liquid chromatography (HPLC), and enzyme multiplied immunoassay (EMIT) for the measurement of serum levels of theophylline were compared below, within, and above the therapeutic range (55-110 mumol/L) using data from 63 samples from the Heathcontrol quality assurance scheme. Within the therapeutic range, the methods did not differ in either precision or accuracy. Coefficients of variation (CV) of measurements were between 12 and 16%, and measurements did not differ from spiked values. Below the therapeutic range, the methods differed significantly. The GLC methods had the lowest precision (CV 23-25%), while the CV for HPLC was 19% and for EMIT 14%. GLC + D and HPLC also overestimated drug level by 11 and 8%, respectively. Above the therapeutic range, the precision of the methods did not differ (CV 10-13%), although both EMIT and HPLC underestimated theophylline level by 5-6%. In a comparison of individual laboratories based on a ranking of overall precision, laboratories employing GLC commonly exhibited less precise rank positions than laboratories using EMIT. Laboratories making HPLC measurements showed a bimodal distribution but no methodological differences were identified to explain this difference in precision.
利用来自健康控制质量保证计划的63个样本的数据，对气相色谱法（无论是否衍生化，即气相色谱 + 衍生化法、非衍生化气相色谱法）、高压液相色谱法（HPLC）以及酶放大免疫分析技术（EMIT）在测定血清中茶碱水平时，于治疗范围（55 - 110 μmol/L）以下、范围内及以上的准确性和精密度进行了比较。在治疗范围内，这些方法在精密度或准确性方面并无差异。测量的变异系数（CV）在12%至16%之间，且测量值与加标值无差异。在治疗范围以下，这些方法存在显著差异。气相色谱法的精密度最低（CV为23% - 25%），而HPLC的CV为19%，EMIT的CV为14%。气相色谱 + 衍生化法和HPLC分别将药物水平高估了11%和8%。在治疗范围以上，这些方法的精密度并无差异（CV为10% - 13%），不过EMIT和HPLC均将茶碱水平低估了5% - 6%。在基于总体精密度排名对各实验室进行的比较中，采用气相色谱法的实验室通常比使用EMIT的实验室表现出更低的精密度排名。进行HPLC测量的实验室呈现出双峰分布，但未发现方法学差异来解释这种精密度差异。
