Evidence map›Paper›PMID 40092163›Full record

ArticleBiochemistry and biophysics reports2025

Development and analytical performance of a new research use only (RUO) GP73 automated immunoassay.

Shaohua Ning, Enfu Liu, Fanju Meng, Fei Chen, James Hartnett, Zhihong Lin, Bailin Tu, David J Hawksworth, Bryan C Tieman, De Yu Mao and 4 more

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In one paragraph

Article in Biochemistry and biophysics reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

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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

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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

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0 citing papers in PubMed.

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4 · The record

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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

14 authors.

Shaohua NingDiagnostics Discovery Research & Development, Abbott Diagnostics, Shanghai, China.
Enfu LiuDiagnostics Discovery Research & Development, Abbott Diagnostics, Shanghai, China.
Fanju MengDiagnostics Discovery Research & Development, Abbott Diagnostics, Shanghai, China.
Fei ChenDiagnostics Discovery Research & Development, Abbott Diagnostics, Shanghai, China.
James HartnettDiagnostics Discovery Research & Development, Abbott Diagnostics, Abbott Park, IL, USA.
Zhihong LinDiagnostics Discovery Research & Development, Abbott Diagnostics, Abbott Park, IL, USA.
Bailin TuDiagnostics Discovery Research & Development, Abbott Diagnostics, Abbott Park, IL, USA.
David J HawksworthDiagnostics Discovery Research & Development, Abbott Diagnostics, Abbott Park, IL, USA.
Bryan C TiemanDiagnostics Discovery Research & Development, Abbott Diagnostics, Abbott Park, IL, USA.
De Yu MaoDiagnostics Discovery Research & Development, Abbott Diagnostics, Abbott Park, IL, USA.
Ryan PiktelDiagnostics Discovery Research & Development, Abbott Diagnostics, Abbott Park, IL, USA.
Amit KumarDiagnostics Discovery Research & Development, Abbott Diagnostics, Abbott Park, IL, USA.
You PanDiagnostics Discovery Research & Development, Abbott Diagnostics, Abbott Park, IL, USA.
Philip M HemkenDiagnostics Discovery Research & Development, Abbott Diagnostics, Abbott Park, IL, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Golgi protein 73 (GP73) is a serum marker with potential applications in the assessment of chronic liver disease progression. We developed a research use only (RUO) GP73 immunoassay to detect serum GP73 concentration. A pair of internal antibodies that most effectively capture and detect GP73 were used to develop a prototype assay. An internal recombinant GP73 standard was used to prepare the assay calibrator and controls. The stability performance of the antibodies and GP73 calibrator were evaluated. We analyzed assay performance on the automated Alinity i system, including precision, sensitivity, linearity, endogenous interference, and HAMA/RF interference. The RUO Alinity i GP73 immunoassay showed good stability when the reagent kit was stored on board the instrument for more than 30 days without recalibration. The internal GP73 calibrator was stable at 2-8 °C for 28 days. Total %CV for 20 days was ≤3 %. The limit of quantitation (LoQ) at 20 % CV was 0.20 ng/mL or lower. Dilution analysis yielded a linear result within the range of 2.1 ng/mL - 1000.0 ng/mL. No interference was observed from common endogenous interferents at each test interference level. These findings support the reliability and robustness of the RUO Alinity i GP73 immunoassay for measuring serum GP73 concentration.

Indexed as

Automated immunoassayBiomarkerGP73HepatitisLiver disease

Identifiers

PMID40092163
PMCPMC11910086

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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.