ArticleJournal of clinical laboratory analysis2018
Evaluation of the highly sensitive chemiluminescent enzyme immunoassay "Lumipulse HBsAg-HQ" for hepatitis B virus screening.
Article in Journal of clinical laboratory analysis, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
18 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Diagnostic accuracy of LAMP assay for HBV infection.Journal of clinical laboratory analysis · 2020Pooled it
- Identification and characteristics of mutations promoting occult HBV infection by ultrasensitive HBsAg assay.Journal of clinical microbiology · 2025Article
- Transfusion-transmitted occult hepatitis B virus infection: current understanding, challenges, and its implication in blood safety.Frontiers in immunology · 2025Review
- Review
- Impact of preS1 Evaluation in the Management of Chronic Hepatitis B Virus Infection.Medicina (Kaunas, Lithuania) · 2024Article
- [Expert consensus on the clinical application of the markers of hepatitis B virus].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2023Article
- Accuracy Validation of the Elecsys HBsAg II Quant Assay and Its Utility in Resolving Equivocal Qualitative HBsAg Results.Medicina (Kaunas, Lithuania) · 2023Article
- Control of occult hepatitis B virus infection.Advances in laboratory medicine · 2022Article
- A roadmap for serum biomarkers for hepatitis B virus: current status and future outlook.Nature reviews. Gastroenterology & hepatology · 2022Review
- Circulating immune complexes and mutations of HBsAg are associated with the undetectable HBsAg in anti-HBs and HBeAg positive occult hepatitis B virus infection.Frontiers in microbiology · 2022Article
- Analytical Performance of the Sysmex HISCL HBsAg Assay and Comparison with the Roche Elecsys HBsAg II Quant Assay in the Quantification of Hepatitis B Surface Antigen.Medicina (Kaunas, Lithuania) · 2021Article
- Hepatitis B Virus Reactivation upon Immunosuppression: Is There a Role for Hepatitis B Core-Related Antigen in Patients with Immune-Escape Mutants? A Case Report.Diagnostics (Basel, Switzerland) · 2021Article
- Novel Biomarkers of Hepatitis B Virus and Their Use in Chronic Hepatitis B Patient Management.Viruses · 2021Review
- Analysis of hepatitis B and C virus infections amongst members of the Dental National Health Insurance Society in the Oita Prefecture.Biomedical reports · 2021Article
- The evolution and clinical impact of hepatitis B virus genome diversity.Nature reviews. Gastroenterology & hepatology · 2020Review
- Insignificant interference of Elevit in pregnant women serum samples with HBsAg immunoassay on Sysmex.Journal of clinical laboratory analysis · 2019Article
- Evaluation of the highly sensitive chemiluminescent enzyme immunoassay "Lumipulse HBsAg-HQ" for hepatitis B virus screening.Journal of clinical laboratory analysis · 2018Article
- Hepatitis B Virus Blood Screening: Need for Reappraisal of Blood Safety Measures?Frontiers in medicine · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOngoing efforts in the development of HBsAg detection kits are focused on improving sensitivity and specificity. The purpose of this study was to evaluate an improved, highly sensitive quantitative assay, "Lumipulse HBsAg-HQ", a chemiluminescent enzyme immunoassay designed for a fully automated instrument, the "Lumipulse G1200".
methodsSerum samples for reproducibility, dilution, correlation, sensitivity, and specificity studies were obtained from patients at the Osaka University Hospital. Seroconversion and sensitivity panels were purchased from a commercial vender. Subtype, sensitivity panels, and HBsAg recombinant proteins with one or two amino acid substitutions were prepared in-house.
resultsThe coefficients of variation for the low, medium, and high concentration samples ranged from 1.93 to 2.55%. The HBsAg-HQ reagent for dilution testing showed good linearity in the 0.005-150 HBsAg IU/mL range and no prozone phenomenon. All 102 HBV carrier samples were positive by HBsAg-HQ, while other commercial reagents showed one or more to be negative. In the seroconversion panel, the 14-day blood sample was positive. The sensitivity against HBsAg-HQ "ad" and "ay" subtypes was 0.025 ng/mL. Comparisons among the HBsAg-HQ, HISCL, and Architect HBsAg reagents were performed using the Bland-Altman plot. Specificity for 1000 seronegative individuals was 99.7%. HBsAg-HQ detected 29 positive serum among 12 231 routinely obtained serum samples, which showed concentrations of 0.005-0.05 HBsAg IU/mL.
conclusionsAccording to these results, the Lumipulse HBsAg-HQ assay, with a highly sensitive limit of detection of 0.005 IU/mL, may facilitate the development of a better management strategy for a considerable proportion of infected patients.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.