Evidence map›Paper›PMID 42200146›Full record

ArticlePractical laboratory medicine2026

Performance validation and clinical concordance of a novel fully automated immunoassay system for five tumor markers: A comparative study with an international reference platform.

Ruobing Wang, Jianmin Liu, Ting Cao, Xiaohan Qiao, Xinyu Deng, Tianhuan Xiong, Yaoyao Yang, Junge Zhang, Min Li, Wei Liang

Abstract read
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In one paragraph

Article in Practical laboratory medicine, 2026. 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

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

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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

Who cites it

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4 · The record

Corrections and comments

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5 · Who and what money

Authors and funding

10 authors.

Ruobing WangDepartment of Laboratory Medicine, The First Affiliated Hospital of Ningbo University, Ningbo, 315000, China.
Jianmin LiuHealth BioMed Co., Ltd., Ningbo, 315000, China.
Ting CaoDepartment of Laboratory Medicine, The First Affiliated Hospital of Ningbo University, Ningbo, 315000, China.
Xiaohan QiaoDepartment of Laboratory Medicine, The First Affiliated Hospital of Ningbo University, Ningbo, 315000, China.
Xinyu DengDepartment of Laboratory Medicine, The First Affiliated Hospital of Ningbo University, Ningbo, 315000, China.
Tianhuan XiongDepartment of Laboratory Medicine, The First Affiliated Hospital of Ningbo University, Ningbo, 315000, China.
Yaoyao YangDepartment of Laboratory Medicine, The First Affiliated Hospital of Ningbo University, Ningbo, 315000, China.
Junge ZhangDepartment of Laboratory Medicine, The First Affiliated Hospital of Ningbo University, Ningbo, 315000, China.
Min LiSchool of Laboratory Medicine, Wenzhou Medical University, Wenzhou, 325000, China.
Wei LiangDepartment of Laboratory Medicine, The First Affiliated Hospital of Ningbo University, Ningbo, 315000, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: The high cost of imported platforms limits widespread lung cancer risk stratification in resource-limited settings. Based on CLSI guidelines, this study aimed to conduct a preliminary analytical verification of a novel automated chemiluminescence immunoassay system (Health) for five tumor markers (SCC, CEA, CYFRA21-1, Pro-GRP, and NSE), and to compare it with established reference systems. Methods: Analytical precision and method comparison with Roche, Abbott, and Beckman platforms were verified referencing CLSI EP recommendations. A total of 180 patients with lung cancer and 77 healthy controls were enrolled. Receiver operating characteristic (ROC) curve analysis was performed to evaluate the diagnostic performance of individual tumor markers and their combined use. Results: The evaluated system demonstrated good precision across all analytes, with within-run and total coefficients of variation below 6.8%. Deming regression demonstrated high quantitative ( Conclusion: Following preliminary verification, the system showed acceptable analytical performance and satisfactory reference concordance. While offering a cost-effective adjunctive tool for preliminary risk assessment, its clinical use requires external validation.

Indexed as

Chemiluminescence immunoassayDiagnostic performanceLung cancerMethod comparisonTumor markers

Identifiers

PMID42200146
PMCPMC13200117

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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.