Ann Lab Med 2019; 39(3): 245-251  https://doi.org/10.3343/alm.2019.39.3.245
Analytical and Clinical Performance of the Nanopia Krebs von den Lungen 6 Assay in Korean Patients With Interstitial Lung Diseases
Eun-Jung Cho, M.D., Ph.D.1,2, Kyoung-Jin Park, M.D., Ph.D.3, Dae-Hyun Ko, M.D., Ph.D.3, Hyun Jung Koo, M.D., Ph.D.4, Sang Min Lee, M.D., Ph.D.4, Jin Woo Song, M.D., Ph.D.5, Woochang Lee, M.D., Ph.D.3, Hae Kyung Lee, M.D., Ph.D.1, Kyung-Hyun Do, M.D., Ph.D.4, Sail Chun, M.D., Ph.D.3, and Won-Ki Min , M.D., Ph.D.3
1Department of Laboratory Medicine, The Catholic University of Korea, Uijeongbu St. Mary’s Hospital, Seoul, Korea; 2Department of Laboratory Medicine, Hallym University College of Medicine, Hwaseong, Korea; Departments of 3Laboratory Medicine, 4Radiology, and 5Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Corresponding author: Won-Ki Min, M.D. https://orcid.org/0000-0002-5158-2130
Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea
Tel: +82-2-3010-4503
Fax: +82-2-478-0884
E-mail: wkmin@amc.seoul.kr
Received: February 5, 2018; Revised: June 26, 2018; Accepted: December 13, 2018; Published online: May 1, 2019.
© Korean Society for Laboratory Medicine. All rights reserved.

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Abstract
Background: 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.
Methods: 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.
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 (r=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.
Conclusions: 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.
Keywords: ELISA, High-resolution computed tomography, Interstitial lung diseases, Krebs von den Lungen 6, Performance evaluation, Pulmonary function test



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