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Original Article

SPAPLUS 분석기의 혈청 IgD 정량검사 성능평가 및 한국인에서 IgD의 참고구간 설정

Performance Evaluation of Serum IgD Quantification by the SPAPLUS Turbidimetric Analyzer and Determination of a Reference Interval of IgD in the Korean Population

조은혜1·박현경2·박형두1

1성균관대학교 의과대학 삼성서울병원 진단검사의학과
2서울의과학연구소

Eun Hye Cho, M.D.1, Hyun-Kyung Park, M.D.2, Hyung-Doo Park, M.D. 1

1Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
2Seoul Clinical Laboratories, Seoul, Korea

Correspondence to:
Hyung-Doo Park, M.D., Ph.D.
https://orcid.org/0000-0003-1798-773X
Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, Korea
Tel: +82-2-3410-0290, Fax: +82-2-3410-2719, E-mail: nayadoo@hanmail.net
Received: March 19, 2019; Revised: October 8, 2019; Accepted: October 10, 2019

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Lab Med Online 2020; 10(3): 197-201

Published July 1, 2020 https://doi.org/10.3343/lmo.2020.10.3.197

Copyright © The Korean Society for Laboratory Medicine.

Abstract

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배경: IgD는 혈청 총 면역글로불린의 1% 미만을 차지하는데, 특정한 임상 상황에서 농도 변화가 나타날 수 있다. 이 연구에서는 혼탁면역법을 이용하는 SPAPLUS 분석기(The Binding Site, UK)의 혈청 IgD 정량에 대한 성능 평가 및 한국인에서 IgD의 참고구간을 설정하였다.
방법: CLSI (Clinical and Laboratory Standards Institute) 가이드라인에 따라 정밀도와 직선성을 평가하였으며 참고구간 설정을 진행하였다. 또한 BNII (Siemens Healthineers, Germany) 장비와의 비교 분석을 함께 진행하였다.
결과: 세 가지 농도 검체에 대하여 반복정밀도(%CV)는 0.78-2.14%, 검사실 내 정밀도(%CV)는 4.10-5.40%의 결과를 보였으며, 분석측정범위 내에서 직선성을 유지하였다(R2=0.9996). SPAPLUS와 BNII 장비 간 IgD 측정값은 다음과 같은 상관관계를 보였다(y=0.890x- 1.852, r=0.984). 하지만 100 mg/L 이상의 농도에서는 SPAPLUS가 BNII보다 낮은 농도를 보이는 경향이 있었다. 설정된 참고구간의 상한치는 53.6 mg/L이었다.
결론: SPAPLUS 장비는 혈청 IgD 정량에 대해서 우수한 검사 수행능을 보여주었다.
Background: IgD is an immunoglobulin isotype that accounts for <1% of the total serum immunoglobulin, and IgD level changes can be observed in specific clinical situations. Herein, we evaluated the analytical performances of serum IgD quantification by the SPAPLUS turbidimetric analyzer (The Binding Site, UK), and determined a reference interval of IgD in the Korean population.
Methods: Precision, linearity and comparison with BNII (Siemens Healthineers, Germany) were assessed, and a reference interval was established according to the Clinical and Laboratory Standards Institute guidelines.
Results: Repeatability ranged from 0.78% to 2.14%, and the within-laboratory precision ranged from 4.10% to 5.40% for three concentrations. The coefficient of determination (R2) was 0.9996 for the analytical measurement range. The IgD concentration showed a correlation between SPAPLUS and BNII (y=0.890x-1.852, r=0.984). However, IgD concentrations tended to be lower in SPAPLUS compared to those in BNII at concentrations >100 mg/L. The established upper limit of the reference interval was 53.6 mg/L.
Conclusions: The SPAPLUS shows good analytical performance for serum IgD quantification.

Keywords

Analytical performance, IgD, Monoclonal gammopathy, Reference interval, Turbidimetry

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