Evidence map›Paper›PMID 35708142›Full record

ArticleJournal of clinical laboratory analysis2022

Performance evaluation of a laboratory-developed light-initiated chemiluminescence assay for quantification of egg white-specific IgE.

Xin Tan, Bei Zhang, Lisheng Zheng, Hongbin Shi, Dandan Liu, Yuanmin Sun, Xue Li, Huiqiang Li

Open access · goldAbstract read
In one paragraph

Article in Journal of clinical laboratory analysis, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.7field-weighted citation impact, top 34% 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

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. Article
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

8 authors at 3 institutions in 1 country.

Xin TanSchool of Medical Laboratory, Tianjin Medical University, Tianjin, China.ORCID https://orcid.org/0000-0002-9941-5331
Bei ZhangSchool of Medical Laboratory, Tianjin Medical University, Tianjin, China.
Lisheng ZhengDepartment of Clinical Laboratory, Tianjin Children's Hospital, Tianjin University, Tianjin, China.
Hongbin ShiPrecision Medicine Center, Tianjin Medical University General Hospital, Tianjin, China.
Dandan LiuSchool of Medical Laboratory, Tianjin Medical University, Tianjin, China.
Yuanmin SunSchool of Medical Laboratory, Tianjin Medical University, Tianjin, China.
Xue LiSchool of Medical Laboratory, Tianjin Medical University, Tianjin, China.ORCID https://orcid.org/0000-0002-0077-8328
Huiqiang LiSchool of Medical Laboratory, Tianjin Medical University, Tianjin, China.ORCID https://orcid.org/0000-0003-1632-4598
Tianjin Medical University · CNTianjin Medical University General Hospital · CNTianjin University · CN

Funding

National Natural Science Foundation of China 81772259Tianjin Municipal Education Commission 2019KJ180
6 · The paper itself

Abstract

backgroundSpecific IgE (sIgE) testing has become one of the most important tools for diagnosing IgE-mediated food allergy. Enzyme-linked immunosorbent assay (ELISA) and dot-enzyme-linked immunosorbent assay (Dot-ELISA) have been used to measure sIgE in clinical widely. Light-initiated chemiluminescence assay (LICA) is a new method for measuring allergen-sIgE. We aimed to establish a LICA method for quantitative detection of egg white-sIgE and evaluate its performances.

methodsThe best chemibeads coupling method in detecting egg white-sIgE was selected, and a LICA method for quantitative detection of egg white-sIgE was established. The precision study was performed according to Clinical and Laboratory Standards Institute (CLSI) EP5-A2. Detection capability which contains limit of blank (LoB), limit of detection (LoD), and limit of quantitation (LoQ) was evaluated according to National Health Commission of the People's Republic of China (NHC) WS/T 514-2017. Linear range was evaluated according to CLSI EP6-A. All data were analyzed using SPSS software.

resultsPrecision contains repeatability and intermediate precision. The CV of repeatability ranged from 2.72% to 7.29%, and the CV of intermediate precision ranged from 4.93% to 8.64%. The LoB, LoD, and LoQ of the assay were 0.000 kUA/L, 0.053 kUA/L, and 0.076 kUA/L. The assay linear range was 0.076-34.125 kU

conclusionThis laboratory-developed LICA method can detect egg white-sIgE, and performance meets clinical requirements. This method shows rapid turnaround cycles and high sensitivity. It can be used as an alternative method for clinical detection of egg white-sIgE.

Indexed as

AllergensFood HypersensitivityEgg WhiteHumansImmunoglobulin ELuminescenceAllergensImmunoglobulin Eegg white-specific IgEevaluationlight-initiated chemiluminescent assayperformancequantification

Identifiers

PMID35708142
PMCPMC9279973
OpenAlexW4282969924

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

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.