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KMID : 1100720190390030251
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Annals of Laboratory Medicine
2019 Volume.39 No. 3 p.251 ~ p.257
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Analytical and Clinical Performance of the Nanopia Krebs von den Lungen 6 Assay in Korean Patients With Interstitial Lung Diseases
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Cho Eun-Jung
Park Kyoung-Jin
Ko Dae-Hyun
Koo Hyun-Jung
Lee Sang-Min
Song Jin-Woo
Lee Woo-Chang
Lee Hae-Kyung
Do Kyung-Hyun
Chun Sa-Il
Min Won-Ki
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Abstract
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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.
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KEYWORD
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ELISA, High-resolution computed tomography, Interstitial lung diseases, Krebs von den Lungen 6, Performance evaluation, Pulmonary function test
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