Salvagno Gian Luca, Ferrari Anna, Gelati Matteo, Brocco Giorgio, Lippi Giuseppe
Section of Clinical Biochemistry, University of Verona, Verona, Italy.
Laboratory of Clinical Chemistry and Hematology, University Hospital of Verona, Verona, Italy.
Pract Lab Med. 2017 Apr 27;8:60-64. doi: 10.1016/j.plabm.2017.04.006. eCollection 2017 Aug.
This study was designed to validate the analytical performance of the new Gentian particle-enhanced enhanced turbidimetric immunoassay (PETIA) for measuring neutrophil gelatinase-associated lipocalin (NGAL) in serum samples.
Analytical validation of the Gentian NGAL assay was carried out on a Roche Cobas c501 and was based on assessment of limit of blank (LOB), limit of detection (LOD), functional sensitivity, imprecision, linearity and concordance with the BioPorto NGAL test.
The LOB and LOD of Gentian NGAL were found to be 3.8 ng/mL and 6.3 ng/mL, respectively. An analytical coefficient of variation (CV) of 20% corresponded to a NGAL value of 10 ng/mL. The intra-assay and inter-assay imprecision (CV) was between 0.4 and 5.2% and 0.6 and 7.1% and the total imprecision (CV) was 3.7%. The linearity was optimal at NGAL concentrations between 37 and 1420 ng/mL (r=1.00; p<0.001). An excellent correlation was observed between values measured with Gentian NGAL and BioPorto NGAL in 74 routine serum samples (r=0.993). The mean percentage bias of the Gentian assay versus the Bioporto assay was +3.1% (95% CI, +1.6% to +4.5%).
These results show that Gentian NGAL may be a viable option to other commercial immunoassays for both routine and urgent assessment of serum NGAL.
本研究旨在验证新型龙胆紫颗粒增强比浊免疫分析法（PETIA）检测血清样本中中性粒细胞明胶酶相关脂质运载蛋白（NGAL）的分析性能。
在罗氏Cobas c501上对龙胆紫NGAL检测法进行分析验证，基于空白限（LOB）、检测限（LOD）、功能灵敏度、不精密度、线性以及与BioPorto NGAL检测法的一致性评估。
龙胆紫NGAL的LOB和LOD分别为3.8 ng/mL和6.3 ng/mL。分析变异系数（CV）为20%时对应的NGAL值为10 ng/mL。批内和批间不精密度（CV）分别在0.4%至5.2%和0.6%至7.1%之间，总不精密度（CV）为3.7%。在NGAL浓度为37至1420 ng/mL之间线性最佳（r = 1.00；p < 0.001）。在74份常规血清样本中，龙胆紫NGAL和BioPorto NGAL测得的值之间观察到极好的相关性（r = 0.993）。龙胆紫检测法相对于Bioporto检测法的平均偏差百分比为 +3.1%（95% CI，+1.6%至 +4.5%）。
这些结果表明，对于血清NGAL的常规和紧急评估，龙胆紫NGAL可能是其他商业免疫分析法的可行选择。
