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

IF 2.3 Q3 BIOCHEMISTRY & MOLECULAR BIOLOGY

Biochemistry and Biophysics Reports Pub Date : 2025-02-25 DOI:10.1016/j.bbrep.2025.101961

Shaohua Ning , Enfu Liu , Fanju Meng , Fei Chen , James Hartnett , Zhihong Lin , Bailin Tu , David J. Hawksworth , Bryan C. Tieman , De Yu Mao , Ryan Piktel , Amit Kumar , You Pan , Philip M. Hemken

{"title":"Development and analytical performance of a new research use only (RUO) GP73 automated immunoassay","authors":"Shaohua Ning , Enfu Liu , Fanju Meng , Fei Chen , James Hartnett , Zhihong Lin , Bailin Tu , David J. Hawksworth , Bryan C. Tieman , De Yu Mao , Ryan Piktel , Amit Kumar , You Pan , Philip M. Hemken","doi":"10.1016/j.bbrep.2025.101961","DOIUrl":null,"url":null,"abstract":"<div><div>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.</div></div>","PeriodicalId":8771,"journal":{"name":"Biochemistry and Biophysics Reports","volume":"41 ","pages":"Article 101961"},"PeriodicalIF":2.3000,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Biochemistry and Biophysics Reports","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2405580825000482","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"BIOCHEMISTRY & MOLECULAR BIOLOGY","Score":null,"Total":0}

引用次数: 0

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.

查看原文本刊更多论文

求助全文

约1分钟内获得全文求助全文

来源期刊

Biochemistry and Biophysics Reports Biochemistry, Genetics and Molecular Biology-Biophysics

CiteScore

4.60

自引率

0.00%

发文量

191

审稿时长

59 days

期刊介绍： Open access, online only, peer-reviewed international journal in the Life Sciences, established in 2014 Biochemistry and Biophysics Reports (BB Reports) publishes original research in all aspects of Biochemistry, Biophysics and related areas like Molecular and Cell Biology. BB Reports welcomes solid though more preliminary, descriptive and small scale results if they have the potential to stimulate and/or contribute to future research, leading to new insights or hypothesis. Primary criteria for acceptance is that the work is original, scientifically and technically sound and provides valuable knowledge to life sciences research. We strongly believe all results deserve to be published and documented for the advancement of science. BB Reports specifically appreciates receiving reports on: Negative results, Replication studies, Reanalysis of previous datasets.