Evidence map›Paper›PMID 33847629›Full record

ArticleMedicine2021

Performance evaluation of CA242 by flow fluorescence assay.

Yanyan Hou, Yongquan Chen, Jieli Sun, Jinting Geng, Hongwei Jin, Zhongying Zhang

Open access · goldAbstract read
In one paragraph

Article in Medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 95% 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

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

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

6 authors at 1 institution in 4 countries.

Yanyan HouXiamen Key Laboratory of Biomarker Translational Medicine, Center of Clinical Laboratory, Xiamen Humanity Hospital Fujian Medical University, Xiamen, Fujian, China.ORCID 0000-0001-9386-8439
Yongquan Chen
Jieli Sun
Jinting Geng
Hongwei Jin
Zhongying Zhang
Fujian Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

abstractCarbohydrate antigen 24-2 (CA24-2) is usually used as a biomarker for the diagnosis of pancreatic cancer and colorectal cancer. Currentlly, a new quantitative assay kit for CA242 by flow fluorometry assay (FFA) was developed by Shanghai Tellgen Cooperation Co. Ltd. China. Therefore, we conducted the performance evaluation for it.According to the "Guiding principles on performance analysis of diagnostic reagents in vitro" and "American association of clinical laboratory standardization guidelines EP15-A2", the accuracy, precision, linear range, reportable range, biological reference interval verification, carry-over contamination rate, anti-interference capability and cross reaction of the assay kit used in TESMI F3999-Luminex200 automatic immunoassay system were evaluated. In addition, the assay kit was performed in parallel to CanAg kit (CanAg Diagnostics Products Beijing Co., Ltd.) to analyze the correlation between the 2 kits.The bias of accuracy of the new assay kit was less than 12.5% and the coefficient of variations (CVs) of precision were all less than 10.0%. The linear range of CA242 concentration of the testing kit was between 3.46 U/ml and 434.76 U/ml and the reportable range was 6.00 to 535.13 U/ml. The CA242 reference interval 0.00 to 20.00 U/ml was suitable for use in laboratory. The carry-over contamination rate was -0.14%. Correlation analysis showed a satisfactory relevance and consistency (r = 0.982, P < .001) between the new assay kit and CanAg kit, with a regression equation Y = 1.0012X to 0.878 (R2 = 0.9647, P < .001). No statistically significant difference between serum samples without interferences and samples containing lipemia, bilirubin and hemoglobin. And no cross reaction existed between the assay kit and the other tumor markers, such as carbohydrate antigen 125 (CA125), alpha-fetoprotein (AFP), and cytokeratin-19 soluble fragment (CYFRA21-1).The new CA242 quantitative assay kit possesses good detection performance when it is used in TESMI F3999-Luminex200 automatic immunoassay system, which can be used for the examination of CA242 in clinical practice.

Indexed as

Antigens, Tumor-Associated, CarbohydrateFluorometryHumansSensitivity and SpecificityAntigens, Tumor-Associated, Carbohydrate

Identifiers

PMID33847629
PMCPMC8052011
OpenAlexW3155489410

What OpenQuestion holds

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LicenceCC BY-NC
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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.