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

Seung Jun Choi, Yongjung Park, Eun Young Lee, Sinyoung Kim, Hyonsuk Kim

Research output: Contribution to journalArticle

7 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)204-206
Number of pages3
JournalJournal of Clinical Laboratory Analysis
Volume27
Issue number3
DOIs
Publication statusPublished - 2013 May 1

Fingerprint

Viruses
Hepatitis B virus
Hepatitis B e Antigens
Serum
Immunoassay
Antibodies
Hepatitis B Core Antigens
Tokyo
Serologic Tests
Surface Antigens
Hepatitis B Surface Antigens
Hepatitis B
Germany
Japan
Antigens

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Hematology
  • Public Health, Environmental and Occupational Health
  • Clinical Biochemistry
  • Medical Laboratory Technology
  • Biochemistry, medical
  • Microbiology (medical)

Cite this

Choi, Seung Jun ; Park, Yongjung ; Lee, Eun Young ; Kim, Sinyoung ; Kim, Hyonsuk. / Performance Evaluation of LUMIPULSE G1200 Autoimmunoanalyzer for the Detection of Serum Hepatitis B Virus Markers. In: Journal of Clinical Laboratory Analysis. 2013 ; Vol. 27, No. 3. pp. 204-206.
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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.",
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Performance Evaluation of LUMIPULSE G1200 Autoimmunoanalyzer for the Detection of Serum Hepatitis B Virus Markers. / Choi, Seung Jun; Park, Yongjung; Lee, Eun Young; Kim, Sinyoung; Kim, Hyonsuk.

In: Journal of Clinical Laboratory Analysis, Vol. 27, No. 3, 01.05.2013, p. 204-206.

Research output: Contribution to journalArticle

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AU - Kim, Hyonsuk

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