Evidence map›Paper›PMID 42143214›Full record

ArticleBMC infectious diseases2026

Development and performance evaluation of a recombinant antigen - based ELISA and immunochromatography test for HCMV IgG detection.

Mengjiao Lin, Ni Yao, Miaomiao Li, Yushan Xu, Dawei Cui, Jue Xie

Abstract readEvaluation Study
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC infectious diseases, 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

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2 · The registry

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

6 authors.

Mengjiao Lin *Department of Blood Transfusion, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Ni Yao *Department of Blood Transfusion, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Miaomiao LiDepartment of Blood Transfusion, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Yushan XuDepartment of Blood Transfusion, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Dawei CuiDepartment of Blood Transfusion, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Jue XieDepartment of Blood Transfusion, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. zyyyxj2011@zju.edu.cn.

Funding

the National Natural Science Foundation of China 82172335the Natural Science Foundation of Zhejiang Province LZ25H200001Zhejiang Provincial Key Research and Development Program 2020C03032
6 · The paper itself

Abstract

backgroundHuman cytomegalovirus (HCMV) is a common pathogen that poses significant health risks, particularly to immunocompromised individuals. This study aims to improve diagnostic accuracy by developing a novel enzyme-linked immunosorbent assay (ELISA) and colloidal gold immunochromatography assay (GICA) utilizing recombinant HCMV proteins (fusion of pp150 and pp28), which offer improved sensitivity and specificity.

methodsA recombinant HCMV antigen was synthesized for the detection of CMV IgG antibodies in 573 serum samples collected from Hangzhou, Zhejiang Province. All samples were analyzed using two in-house developed assays (indirect ELISA and GICA), and 528 of these samples were identified as CMV IgG-positive by a commercial ELISA kit. The diagnostic performance and reliability of the two in-house assays were subsequently compared with those of this commercial ELISA kit.

resultsThe assays showed no cross-reactivity with other viruses, with a coefficient of variation of less than 10%, indicating excellent reproducibility. Compared to the commercial ELISA kit, the concordance rates of the recombinant antigen-based ELISA and GICA were 98.9% and 99.7%, respectively.

conclusionThe ELISA and GICA developed in this study demonstrate high sensitivity and specificity, making them suitable for screening CMV IgG antibodies particularly in immunocompromised individuals. These findings highlight the potential of recombinant antigen-based assays to advance in infectious disease diagnostics. CLINICAL TRIAL NUMBER: Not applicable.

Indexed as

Antibodies, ViralAntigens, ViralChromatography, AffinityCytomegalovirusCytomegalovirus InfectionsImmunoglobulin GEnzyme-Linked Immunosorbent AssayHumansRecombinant ProteinsReproducibility of ResultsSensitivity and SpecificityAntibodies, ViralAntigens, ViralImmunoglobulin GRecombinant ProteinsColloidal gold immunochromatography assayCytomegalovirusDiagnostic performanceEnzyme-linked immunosorbent assay

Identifiers

PMID42143214
PMCPMC13360036

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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.