Evidence map›Paper›PMID 23130341›Full record

ArticleAnnals of laboratory medicine2012

Elecsys hepatitis B surface antigen quantitative assay: performance evaluation and correlation with hepatitis B virus DNA during 96 weeks of follow-up in chronic hepatitis B patients.

Hyun Ji Lee, Shine Young Kim, Sun Min Lee, Jeong Heo, Hyung Hoi Kim, Chulhun L Chang, Eun Yup Lee, Han Chul Son

Open access · hybridAbstract readEvaluation Study
In one paragraph

Article in Annals of laboratory medicine, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.6field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 14 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

Hyun Ji LeeDepartment of Laboratory Medicine, Pusan National University School of Medicine, Busan, Korea.
Shine Young Kim
Sun Min Lee
Jeong Heo
Hyung Hoi Kim
Chulhun L Chang
Eun Yup Lee
Han Chul Son
Pusan National University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTreatment for chronic hepatitis B aims to suppress virus replication and virus sequestration in hepatocytes. Covalently closed circular (ccc) DNA is the template for transcription of viral genes and is responsible for viral persistence. However, limited data are available for quantification of hepatitis B surface antigen (HBsAg) in Korea.

methodsWe evaluated the Elecsys HBsAg II quant assay (Roche Diagnostics, USA) for within-run, between-run, and between-day precisions, linearity, carryover, and clinical specificity. In total, 156 serum samples were evaluated for correlation between HBsAg and hepatitis B virus (HBV) DNA. Serial samples were obtained from 10 patients at 0, 12, 24, 48, 72, and 96 weeks during follow-up.

resultsThe assay detected HBsAg in a linear range of 0.5-48,696 IU/mL. Within-run, between-run, and between-day CVs were 2.9-4.1%, 0-1.5%, and 1.5-4.9%, respectively. Cross-reactivity between potentially interfering substances was absent, and the carryover rate was 0.00002%. The correlation of measurements between the Elecsys assay and HBV DNA PCR was weak (r=0.438, P=0.002). For predicting virologic response, cutoff values of 10,275 IU/mL and 3,846 IU/mL at 12 and 24 weeks after treatment initiation showed positive predictive values of 77.1% and 85% and negative predictive values of 84.6% and 50%, respectively.

conclusionsThe Elecsys HBsAg II quant assay showed good performance for precision, linearity, carryover rate, and specificity. HBsAg level at baseline, 12 weeks, and 24 weeks after treatment initiation can predict virologic response, and the assay can be used for HBsAg quantification in clinical practice.

Indexed as

Analysis of VarianceAntiviral AgentsDNA, ViralFollow-Up StudiesHepatitis B, ChronicHepatitis B Surface AntigensHepatitis B virusHumansPolymerase Chain ReactionReagent Kits, DiagnosticROC CurveTime FactorsAntiviral AgentsDNA, ViralHepatitis B Surface AntigensReagent Kits, DiagnosticChronic hepatitis BHBsAgHepatitis B virusQuantification

Identifiers

PMID23130341
PMCPMC3486936
OpenAlexW2159782527

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.