Department of Laboratory Medicine, The Catholic University of Korea, Uijeongbu St. Mary's Hospital, Seoul, Korea.
Department of Laboratory Medicine, Hallym University College of Medicine, Hwaseong, Korea.
Ann Lab Med. 2019 May;39(3):245-251. doi: 10.3343/alm.2019.39.3.245.
Krebs von den Lungen 6 (KL-6) is a sensitive marker for diagnosing, monitoring, and predicting the prognoses of interstitial lung diseases (ILDs). This study aimed to evaluate the performance of the Nanopia KL-6 assay (Sekisui Medical, Tokyo, Japan) and to test the relationship between KL-6 concentrations and clinical results.
In total, 230 patients diagnosed as having ILDs were enrolled. All underwent high-resolution computed tomography (HRCT) followed by the pulmonary function test (PFT). We also enrolled 116 disease controls and 200 healthy controls. Evaluation of the Nanopia KL-6 assay involved determination of precision, linearity, and limit of quantification (LOQ). Results from the Nanopia KL-6 assay were compared with those from ELISA and correlated with the HRCT and PFT results.
The within-laboratory precisions were <2% of CV, and linearity was acceptable between 52.2 and 4,966.5 U/mL. The LOQ was 45.2 U/mL. Nanopia and ELISA results were strongly correlated (=0.979). The average concentration of KL-6 was greater in ILD patients (711.5 U/mL) than in the disease (168.4 U/mL) and healthy (209.4 U/mL) controls. Serum KL-6 concentrations were strongly and moderately correlated with the extent of lung involvement and presence of typical HRCT abnormalities, respectively, and moderately correlated with PFT parameters.
The overall analytical and clinical performance of the Nanopia KL-6 assay was acceptable. Our study is the first to compare assay platforms and show correlations between KL-6 concentrations and HRCT or PFT results in Korean ILD patients.
肺表面活性物质相关蛋白 D（KL-6）是诊断、监测和预测间质性肺疾病（ILD）的敏感标志物。本研究旨在评估 Nanopia KL-6 检测试剂盒（日本积水医疗株式会社）的性能，并检验 KL-6 浓度与临床结果之间的关系。
共纳入 230 例经临床诊断为 ILD 的患者，所有患者均接受高分辨率计算机断层扫描（HRCT）和肺功能检查（PFT）。此外，还纳入了 116 例疾病对照组和 200 例健康对照组。对 Nanopia KL-6 检测试剂盒的评估包括精密度、线性和定量下限（LOQ）的测定。比较 Nanopia KL-6 检测试剂盒与 ELISA 法的检测结果，并与 HRCT 和 PFT 结果相关联。
室内精密度<2%CV，52.2~4966.5 U/mL 范围内线性关系良好。LOQ 为 45.2 U/mL。Nanopia 和 ELISA 检测结果高度相关（r=0.979）。ILD 患者的 KL-6 平均浓度（711.5 U/mL）高于疾病对照组（168.4 U/mL）和健康对照组（209.4 U/mL）。血清 KL-6 浓度与肺部受累程度呈强相关，与典型 HRCT 异常呈中度相关，与 PFT 参数呈中度相关。
Nanopia KL-6 检测试剂盒的总体分析和临床性能良好。本研究首次比较了不同检测平台，显示了韩国 ILD 患者 KL-6 浓度与 HRCT 或 PFT 结果之间的相关性。
