癌抗原72-4自动化化学发光免疫分析方法的建立及其分析性能评价

Development of an automated chemiluminescent immunoassay for cancer antigen 72-4 and the evaluation of its analytical performance.

作者信息

Yanagihara Fusamitsu, Okura Hideaki, Ichikawa Hisashi, Shirakawa Takuma, Pan You, Tu Bailin, Lin Zhihong, Bonn Ryan, Kurella Sridevi, Schodin Beth, Yoshimura Toru

机构信息

Research and Development, Core Diagnostics, Abbott Japan, Chiba, Japan.

Research and Development, Core Diagnostics, Abbott Laboratories, Lake County, IL, USA.

出版信息

Pract Lab Med. 2023 Jan 14;34:e00308. doi: 10.1016/j.plabm.2023.e00308. eCollection 2023 Mar.

DOI:10.1016/j.plabm.2023.e00308

PMID:36713933

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9879778/

Abstract

OBJECTIVES

Cancer antigen (CA) 72-4 assay is widely used for monitoring gastric and ovarian cancers. The antigen is a mucin-like, tumor-associated glycoprotein known as TAG-72. It has been identified and characterized using two different monoclonal antibodies, CC49 and B72.3, which recognize its glycochain epitopes, Galβ(1-3) sialyl-Tn and sialyl-Tn antigens, respectively. This study describes the quantitative analytical performance of a newly developed CA 72-4 assay, ARCHITECT CA 72-4.

DESIGN

and Methods: The ARCHITECT CA 72-4 assay was developed using the ARCHITECT i2000SRs and three ARCHITECT i1000SRs. The assay performance was evaluated based on guidance from CLSI (Clinical and Laboratory Standards Institute) and correlation against Elecsys CA 72-4.

RESULTS

In the total precision study, the minimum coefficient of variation (CV) for Control/Panel samples over 4 U/mL was 1.1%. The measuring interval was from 0.95 to 200 U/mL with good linearity; and limits of blank (LoB), detection (LoD), and quantitation (LoQ) were 0.09, 0.18, and 0.95 U/mL, respectively. High dose hook effect; differences among specimen tube types; and interference of common drugs, potential cross-reactants, and endogenous substances were not observed. Significantly, this assay has high biotin tolerance at 4875 mg/mL and correlates well with the Elecys CA 72-4 assay (correlation coefficient: 0.95).

CONCLUSIONS

ARCHITECT CA 72-4 is a highly sensitive and precise assay for CA 72-4 measurement in human sera and plasma.

摘要

目的

癌抗原（CA）72-4检测广泛用于监测胃癌和卵巢癌。该抗原是一种黏蛋白样、肿瘤相关糖蛋白，称为TAG-72。它已通过两种不同的单克隆抗体CC49和B72.3进行鉴定和表征，这两种抗体分别识别其糖链表位Galβ(1-3)唾液酸化-Tn和唾液酸化-Tn抗原。本研究描述了新开发的CA 72-4检测方法ARCHITECT CA 72-4的定量分析性能。

设计与方法

使用ARCHITECT i2000SRs和三台ARCHITECT i1000SRs开发了ARCHITECT CA 72-4检测方法。根据临床和实验室标准协会（CLSI）的指导对检测性能进行评估，并与罗氏电化学发光免疫分析法CA 72-4进行相关性分析。

结果

在总精密度研究中，浓度超过4 U/mL的对照/检测组合样本的最小变异系数（CV）为1.1%。测量区间为0.95至200 U/mL，线性良好；空白限（LoB）、检测限（LoD）和定量限（LoQ）分别为0.09、0.18和0.95 U/mL。未观察到高剂量钩状效应、标本管类型之间的差异以及常见药物、潜在交叉反应物和内源性物质的干扰。值得注意的是，该检测方法在4875 mg/mL时具有高生物素耐受性，并且与罗氏电化学发光免疫分析法CA 72-4检测方法相关性良好（相关系数：0.95）。