Evaluation of the HISCL™ KL-6 Reagent for use on a Fully Automated Immunoassay Analyzer HISCL™

• Evaluation of the HISCL™ KL-6 Reagent for use on a Fully Automated Immunoassay Analyzer HISCL™

AUTHOR(S)

Yuji HORIUCHI*^１, Mayumi IKEDA*^１, Shinji OIKAWA*^１, Kenji ABE*^２ and Akira HISHINUMA*^１,３

*1 Department of Clinical Laboratory, Dokkyo Medical University Hospital
*2 Clinical Research Department, EDIA Co., Ltd.
*3 Department of Infection Control and Clinical Laboratory Medicine, Dokkyo Medical University

SUMMARY

Sialylated carbohydrate antigen KL-6 (hereinafter referred to as "KL-6"), an MUC-1 molecule recognized by the anti-KL-6 monoclonal antibody established by Kohno, et al., is a transmembrane glycoprotein expressed on the surface of type 2 alveolar epithelial cells. KL-6 is highly specific to interstitial pneumonia, particularly to the active form rather than inactive interstitial pneumonia, and is therefore widely used as a marker for the diagnosis of interstitial pneumonia and as an indicator of disease activity. In this paper, we report the results of a fundamental study of the fully automated immunoassay analyzer HISCL™ (Sysmex Corporation), which employs a chemiluminescent enzyme immunoassay (CLEIA) detection method, and its HISCL™ KL-6 Reagent. In this study, we evaluated their basic performance and usefulness in routine testing. We also compared the reagent with PicoLumi KL-6, a reagent used in conjunction with the electrochemiluminescence immunoassay device PicoLumi.

KEY WORDS

KL-6, CLEIA Method, Interstitial Pneumonia

NOTE(S)

This article is translated and republished from Japanese Journal of Medicine and Pharmaceutical Science Vol.73 No.4, 2016. (issued in Japan) (Acceptable secondary publication)