Evidence map›Paper›PMID 26666630›Full record

ArticleJournal of clinical laboratory analysis2016

Detection of Human Epididymis Protein 4 (HE4) in Human Serum Samples Using a Specific Monoclonal Antibody-Based Sandwich Enzyme-Linked Immunosorbent Assay (ELISA).

Lijun Zhou, Zhiqiang Lv, Jing Shao, Ying Xu, Xiaohong Luo, Yuming Zhang, Yang Hu, Wenji Zhang, Shuhong Luo, Jianmin Fang and 3 more

Open access · bronzeAbstract read
In one paragraph

Article in Journal of clinical laboratory analysis, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.1field-weighted citation impact, top 21% of its field
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

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

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

2 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
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4 · The record

Corrections and comments

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

13 authors at 4 institutions in 2 countries.

Lijun ZhouDepartment of Clinical Laboratory, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, People's Republic of China.
Zhiqiang LvRaybiotech, Inc, Guangzhou, Guangdong Province, People's Republic of China.
Jing ShaoMedical Research Center, the Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, People's Republic of China.
Ying XuDepartment of Clinical Laboratory, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, People's Republic of China.
Xiaohong LuoDepartment of Clinical Laboratory, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, People's Republic of China.
Yuming ZhangRaybiotech, Inc, Guangzhou, Guangdong Province, People's Republic of China.
Yang HuRaybiotech, Inc, Guangzhou, Guangdong Province, People's Republic of China.
Wenji ZhangRaybiotech, Inc, Guangzhou, Guangdong Province, People's Republic of China.
Shuhong LuoRaybiotech, Inc, Guangzhou, Guangdong Province, People's Republic of China.
Jianmin FangRaybiotech, Inc, Guangzhou, Guangdong Province, People's Republic of China.
Ying WangDepartment of Clinical Laboratory, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, People's Republic of China.
Chaohui DuanDepartment of Clinical Laboratory, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, People's Republic of China. 1725012289@qq.com.
Ruopan HuangRaybiotech, Inc, Guangzhou, Guangdong Province, People's Republic of China. rhuang@raybiotech.com.
RayBiotech (China) · CNSun Yat-sen Memorial Hospital · CNRayBiotech (United States) · USSun Yat-sen University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe human epididymis protein 4 (HE4) may have high specificity in the detection of malignant diseases, making the development of an immunoassay for HE4 essential.

methodsIn our study, a fusion gene was constructed encoded with the HE4 protein. This protein was then produced in the bacterial cells (Escherichia coli) and used to immunize mice in order to eventually generate hybridomas specific to HE4. The hybridoma supernatants were then screened, and four positive anti-HE4 cell lines were selected. These cell lines produce monoclonal antibodies against HE4 epitopes, as demonstrated in the Western blot as well as by direct enzyme-linked immunosorbent assay (ELISA). Using the developed antibodies, we successfully identified several good antibody pairs from the hybridomas, which allowed for the development of a sandwich ELISA to measure HE4 levels. By using the HE4 ELISA, we measured HE4 levels of 60 clinical human serum samples.

resultsCompared with the Food and Drug Administration (FDA) approved kit (Roche), our results showed a strong positive correlation to those of the FDA-approved kit.

conclusionsIn summary, highly sensitive antibody pairs were screened against HE4, and a sandwich ELISA was developed as an accurate analytical tool for the detection of HE4 in human serum, which could be especially valuable for diagnosing ovarian carcinomas.

Indexed as

AdolescentAdultAgedAnimalsAntibodies, MonoclonalAntibody SpecificityCell Line, TumorEnzyme-Linked Immunosorbent AssayFemaleHumansMiceMiddle AgedOvarian NeoplasmsProteinsSensitivity and SpecificityWAP Four-Disulfide Core Domain Protein 2Antibodies, MonoclonalProteinsWAP Four-Disulfide Core Domain Protein 2WFDC2 protein, humanHE4immunoassaymonoclonal antibodyovarian cancersandwich ELISA

Identifiers

PMID26666630
PMCPMC6807063
OpenAlexW2283872289

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Registered trials

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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.