Ann Lab Med.  2019 May;39(3):245-251. 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

Affiliations
  • 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.
  • 3Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. wkmin@amc.seoul.kr
  • 4Department of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
  • 5Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.

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.

Keyword

ELISA; High-resolution computed tomography; Interstitial lung diseases; Krebs von den Lungen 6; Performance evaluation; Pulmonary function test

MeSH Terms

Enzyme-Linked Immunosorbent Assay
Humans
Lung
Lung Diseases, Interstitial*
Prognosis
Respiratory Function Tests
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