PMID- 31730813
OWN - NLM
STAT- MEDLINE
DCOM- 20200729
LR  - 20200729
IS  - 1873-3492 (Electronic)
IS  - 0009-8981 (Linking)
VI  - 501
DP  - 2020 Feb
TI  - Evaluation of a novel serum IgG4 assay and determination of reference interval 
      for the Japanese population.
PG  - 136-141
LID - S0009-8981(19)32097-2 [pii]
LID - 10.1016/j.cca.2019.10.032 [doi]
AB  - BACKGROUND: IgG4-related disease (IgG4-RD) is a new syndrome characterized by 
      elevated serum IgG4 concentration and tissue infiltration of IgG4-positive plasma 
      cells. Here, we evaluated the analytical performance of a new IgG4 assay reagent 
      featuring a wide dynamic range, highly specific monoclonal antibody, and the 
      reversed passive latex agglutination assay and determined the IgG4 reference 
      interval (RI) for the Japanese population. METHODS: Performance evaluations were 
      conducted on precision, linearity, sensitivity, interference, and method 
      comparison with The Binding Site (TBS) and Siemens reagents. The RI was derived 
      by the parametric method from 619 apparently healthy Japanese 18 to 65 years of 
      age. RESULTS: Between-day precisions ranged from 1.99 to 5.52 CV%. Linearity was 
      confirmed up to 5.0 g/l. The limit of quantitation was 0.085 g/l. Interfering 
      substances did not significantly influence values. Method comparison among the 3 
      reagents yielded correlation coefficients between 0.973 and 0.988. Values for the 
      new reagent matched those of TBS reagent except at a higher concentration range, 
      where reactivity dissociated. The RI was 0.11-1.21 g/l without distinction by sex 
      and age. CONCLUSION: The novel IgG4 assay reagent demonstrated satisfactory 
      analytical performance for clinical use. Because of matched value with TBS 
      reagent at low concentrations, it is possible to use the IgG4-RD cut-off value 
      determined by TBS reagent.
CI  - Copyright (c) 2019 The Authors. Published by Elsevier B.V. All rights reserved.
FAU - Usami, Yoko
AU  - Usami Y
AD  - Department of Laboratory Medicine, Shinshu University School of Medicine, 
      Matsumoto, Japan.
FAU - Ichihara, Kiyoshi
AU  - Ichihara K
AD  - Department of Clinical Laboratory Sciences, Faculty of Health Sciences, Yamaguchi 
      University Graduate School of Medicine, Ube, Japan.
FAU - Uehara, Takeshi
AU  - Uehara T
AD  - Department of Laboratory Medicine, Shinshu University School of Medicine, 
      Matsumoto, Japan. Electronic address: tuehara@shinshu-u.ac.jp.
FAU - Sugano, Mitsutoshi
AU  - Sugano M
AD  - Department of Laboratory Medicine, Shinshu University School of Medicine, 
      Matsumoto, Japan.
FAU - Ishimine, Nau
AU  - Ishimine N
AD  - Department of Laboratory Medicine, Shinshu University School of Medicine, 
      Matsumoto, Japan.
FAU - Kawasaki, Kenji
AU  - Kawasaki K
AD  - Division of Laboratory Medicine, Chiba University School of Medicine, Chiba, 
      Japan.
FAU - Yamauchi, Kazuyoshi
AU  - Yamauchi K
AD  - Department of Laboratory Medicine, Faculty of Medicine, University of Tsukuba, 
      Tsukuba, Japan.
FAU - Hamano, Hideaki
AU  - Hamano H
AD  - Department of Gastroenterology, Shinshu University School of Medicine, Matsumoto, 
      Japan.
FAU - Honda, Takayuki
AU  - Honda T
AD  - Department of Laboratory Medicine, Shinshu University School of Medicine, 
      Matsumoto, Japan.
LA  - eng
PT  - Evaluation Study
PT  - Journal Article
DEP - 20191112
PL  - Netherlands
TA  - Clin Chim Acta
JT  - Clinica chimica acta; international journal of clinical chemistry
JID - 1302422
RN  - 0 (Immunoglobulin G)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Autoimmune Diseases/*blood/diagnosis/immunology
MH  - Female
MH  - Healthy Volunteers
MH  - Humans
MH  - Immunoglobulin G/*blood/immunology
MH  - Immunologic Tests/*standards
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Reference Values
MH  - Young Adult
OTO - NOTNLM
OT  - IgG4-related disease
OT  - Latent abnormal values exclusion method
OT  - Monoclonal antibody
OT  - Multiple regression analysis
OT  - Reversed passive latex agglutination assay
EDAT- 2019/11/16 06:00
MHDA- 2020/07/30 06:00
CRDT- 2019/11/16 06:00
PHST- 2019/04/16 00:00 [received]
PHST- 2019/10/16 00:00 [revised]
PHST- 2019/10/23 00:00 [accepted]
PHST- 2019/11/16 06:00 [pubmed]
PHST- 2020/07/30 06:00 [medline]
PHST- 2019/11/16 06:00 [entrez]
AID - S0009-8981(19)32097-2 [pii]
AID - 10.1016/j.cca.2019.10.032 [doi]
PST - ppublish
SO  - Clin Chim Acta. 2020 Feb;501:136-141. doi: 10.1016/j.cca.2019.10.032. Epub 2019 
      Nov 12.