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Performance Evaluation of LUMIPULSE G1200 Autoimmunoanalyzer for the Detection of Serum Hepatitis B Virus Markers

Authors
 Seung Jun Choi  ;  Yongjung Park  ;  Eun Young Lee  ;  Sinyoung Kim  ;  Hyon-Suk Kim 
Citation
 JOURNAL OF CLINICAL LABORATORY ANALYSIS, Vol.27(3) : 204-206, 2013 
Journal Title
 JOURNAL OF CLINICAL LABORATORY ANALYSIS 
ISSN
 0887-8013 
Issue Date
2013
MeSH
Biomarkers/blood ; Hepatitis B/diagnosis ; Hepatitis B/immunology ; Hepatitis B Antibodies/blood* ; Hepatitis B Surface Antigens/blood* ; Humans ; Immunoassay/instrumentation* ; Immunoassay/methods ; Immunologic Tests/instrumentation* ; Immunologic Tests/methods ; Reproducibility of Results
Keywords
hepatitis B virus marker ; automated analyzer ; hepatitis B ; LUMIPULSE G1200 ; immunoassay
Abstract
BACKGROUND: We evaluated recently introduced automated immunoassay analyzer LUMIPULSE G1200 (Fujirebio, Inc., Tokyo, Japan) for detecting serologic hepatitis B virus (HBV) markers by comparison with the results by ARCHITECT i4000SR (Abbott, Abbott Park, IL). METHODS: Precision performance was evaluated over 20 days. HBV surface antigen (HBsAg), HBV e antigen (HBeAg), antibodies to HBV core antigen (anti-HBc), antibodies to HBeAg (anti-HBe), and antibodies to HBsAg (anti-HBs) in a total of 1,000 serum samples were assessed by the two analyzers. Discrepant results were retested by COBAS e411 (Roche Diagnostics, Mannheim, Germany). RESULTS: LUMIPULSE showed excellent precision performance of total imprecision less than 3.5% coefficient of variation. The qualitative results between the two analyzers were agreed with each other in 92.0-99.8% of the specimens according to the different HBV markers. The degrees of reactions for HBeAg were moderately correlated between the two analyzers (r = 0.60), and those of other HBV markers were well correlated (r = 0.80 or greater). However, there were 183 discrepancies among 1,000 cases, and most of them showed degree of reaction around the cutoff values. CONCLUSIONS: LUMIPULSE G1200 showed well-concordant results with ARCITHECT for hepatitis B serologic tests. However, results near the cutoff values would need to be retested with other immunoassay or molecular methods, when the serological profiles of HBV markers are unusual or are not correlated to the clinical conditions of the patient, due to discrepancies between the immunoassay analyzers.
Full Text
http://onlinelibrary.wiley.com/doi/10.1002/jcla.21584/abstract
DOI
10.1002/jcla.21584
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Laboratory Medicine (진단검사의학교실) > 1. Journal Papers
Yonsei Authors
Kim, Sin Young(김신영) ORCID logo https://orcid.org/0000-0002-2609-8945
Kim, Hyon Suk(김현숙) ORCID logo https://orcid.org/0000-0001-5662-7740
Park, Yong Jung(박용정)
Lee, Eun Young(이은영)
Choi, Seung Jun(최승준) ORCID logo https://orcid.org/0000-0003-0736-1055
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/88580
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