Evidence map›Paper›PMID 37571860›Full record

ArticleJournal of clinical laboratory analysis2023

Commutability evaluation of candidate reference materials and ERM-DA470k/IFCC for immunoglobulin M using two international approaches.

Lu Sang, Chunying Wu, Huijuan Chen, Wei Liu, Dawei Huang, Xi Yang, Xinrui Guo, Ruifang Cui, Ning Wang, Rui Zhang and 6 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical laboratory analysis, 2023. 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
–field-weighted citation impact
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.

  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

16 authors.

Lu SangDepartment of Clinical Laboratory, Beijing Huairou Hospital, Beijing, China.ORCID https://orcid.org/0000-0002-0259-9593
Chunying WuDepartment of Clinical Laboratory, Beijing Luhe Hospital, Capital Medical University, Beijing, China.
Huijuan ChenDepartment of Clinical Laboratory, Beijing Huairou Hospital, Beijing, China.
Wei LiuDepartment of Clinical Laboratory, Beijing Luhe Hospital, Capital Medical University, Beijing, China.
Dawei HuangDepartment of Clinical Laboratory, Beijing Longfu Hospital, Beijing, China.
Xi YangDepartment of Clinical Laboratory, Beijing Huairou Hospital, Beijing, China.
Xinrui GuoDepartment of Respiratory and Critical Care Medicine, China-Japan Friendship Hospital, Beijing, China.
Ruifang CuiDepartment of Clinical Laboratory, Heping Hospital Affiliated to Changzhi Medical College, Changzhi, China.
Ning WangDepartment of Clinical Laboratory, Beijing Chaoyang Hospital, The Third Clinical Medical College of Capital Medical University, Beijing, China.
Rui ZhangDepartment of Clinical Laboratory, Beijing Chaoyang Hospital, Beijing Center for Clinical Laboratories, The Third Clinical Medical College of Capital Medical University, Beijing, China.ORCID https://orcid.org/0000-0001-7258-8745
Yuhong YueDepartment of Clinical Laboratory, Beijing Chaoyang Hospital, Beijing Center for Clinical Laboratories, The Third Clinical Medical College of Capital Medical University, Beijing, China.
Hong GuoDepartment of Clinical Laboratory, Heji Hospital Affiliated to Changzhi Medical College, Changzhi, China.
Minghao WangDepartment of Clinical Laboratory, Beijing Chaoyang Hospital, The Third Clinical Medical College of Capital Medical University, Beijing, China.ORCID https://orcid.org/0000-0001-9099-5627
Yutong MiaoDepartment of Clinical Laboratory, Beijing Chaoyang Hospital, The Third Clinical Medical College of Capital Medical University, Beijing, China.
Qingtao WangDepartment of Clinical Laboratory, Beijing Chaoyang Hospital, Beijing Center for Clinical Laboratories, The Third Clinical Medical College of Capital Medical University, Beijing, China.ORCID https://orcid.org/0000-0001-5291-585X
Shunli ZhangDepartment of Clinical Laboratory, Beijing Chaoyang Hospital, Beijing Center for Clinical Laboratories, The Third Clinical Medical College of Capital Medical University, Beijing, China.ORCID https://orcid.org/0000-0003-0527-4388

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study aimed to assess the commutability of frozen pooled human serum (PHS), high concentration of Immunoglobulin M (IgM) pure diluted materials (HPDM), commercialized pure materials (CPM), and dilutions of ERM-DA470k/IFCC in IgM detection using the CLSI and IFCC approaches, to support standardization or harmonization of IgM measurement.

methodsTwenty-four serum samples, relevant reference materials (PHS, HPDM, CPM), and different ERM-DA470k/IFCC dilutions were analyzed in triplicate using six routine methods. The commutability of the relevant reference materials was carried out following CLSI EP30-A and IFCC bias analysis.

resultsAccording to the CLSI approach, low, medium, and high concentrations of PHS, HPDM, and CPM were commutable on 10, 13, 15, 13, and 8 of 15 assay combinations, respectively. Using the IFCC approach, low, medium, and high concentrations of PHS, HPDM, and CPM were commutable on 10, 11, 9, 15, and 10 of 15 assay combinations, respectively. The ERM-DA470k/IFCC dilutions with D-PBS and RPMI-1640 Medium were commutable on 13 of 15 assay combinations according to CLSI and were commutable on all 15 assay combinations using IFCC approach.

conclusionsHigh concentration of PHS were commutable on all six detection systems using the CLSI approach. Low and medium concentration of PHS showed unsatisfied commutability. HPDM, not CPM have good commutability, has the potential to become reference materials. ERM-DA470k/IFCC diluted with different medium showed different commutability.

Indexed as

SerumBlood Coagulation TestsHumansImmunoglobulin MIndicator Dilution TechniquesReference StandardsImmunoglobulin Mcandidate reference materialscommutabilityERM-DA470k/IFCCfrozen pooled human serumIgM

Identifiers

PMID37571860
PMCPMC10492453

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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.