Van Helden Josef, Hermsen Derek, Von Ahsen Nicholas, Bidlingmaier Martin
Clin Lab. 2014;60(10):1641-51. doi: 10.7754/clin.lab.2014.131020.
The aim of the present study was to evaluate the technical performance of a new immunoassay for the detection of human growth hormone.
The Elecsys growth hormone (GH) Immunoassay which is composed of two hGH specific antibodies, one biotinylated monoclonal Ab and one polyclonal Ab coupled with a ruthenium complex, was compared with three currently available automated GH immunoassays.
The performance evaluation resulted in an interassay and total imprecision CV between 0.6-1.7% and 1.7-4.1%, respectively. Using the 20% CV criteria, the functional sensitivity was found at 0.05 μg/L. Pearson's coefficients of correlation were > 0.98 for method comparison to three established automated GH reagents (A-C). Linear regression according to Passing and Bablok showed larger deviations to reagent A (slopes 1.36-1.44), while closer agreement was obtained with reagent B and C. Diagnostic results obtained with the Elecsys® hGH assay in various stimulation and suppression tests of patients with growth hormone deficiency and acromegaly compared to healthy controls were in close agreement to established reagents demonstrating high sensitivity and specificity for the diagnosis of growth hormone disorders.
The evaluation of the GH immunoassay generated homogeneous performance data but the comparison with three established full automated hGH assays demonstrated a considerable degree of variability suggesting assay specific interpretation in the provocation testing of growth hormone disorders. Obviously, such discrepancies limit the applicability of consensus guidelines. Nevertheless, because of its excellent reproducibility, robustness and the short assay time, the new automated hGH assay represents a major improvement in endocrine diagnosis and treatment in clinical practice.
本研究的目的是评估一种用于检测人生长激素的新型免疫测定法的技术性能。
将由两种生长激素特异性抗体（一种生物素化单克隆抗体和一种与钌复合物偶联的多克隆抗体）组成的电化学发光法生长激素（GH）免疫测定法与三种现有的自动化GH免疫测定法进行比较。
性能评估得出批间精密度和总不精密度的变异系数（CV）分别在0.6 - 1.7%和1.7 - 4.1%之间。使用20% CV标准，功能灵敏度为0.05μg/L。与三种已确立的自动化GH试剂（A - C）进行方法比较时，皮尔逊相关系数> 0.98。根据帕欣和巴布洛克法进行的线性回归显示，与试剂A的偏差较大（斜率为1.36 - 1.44），而与试剂B和C的一致性更高。在生长激素缺乏症和肢端肥大症患者的各种刺激和抑制试验中，与健康对照相比，使用电化学发光法hGH测定法获得的诊断结果与已确立的试剂密切一致，表明对生长激素紊乱的诊断具有高灵敏度和特异性。
GH免疫测定法的评估产生了均匀的性能数据，但与三种已确立的全自动hGH测定法的比较显示出相当程度的变异性，这表明在生长激素紊乱的激发试验中需要进行特定分析。显然，这种差异限制了共识指南的适用性。尽管如此，由于其出色的重现性、稳健性和较短的测定时间，这种新型自动化hGH测定法代表了临床实践中内分泌诊断和治疗的重大改进。
