Evidence map›Paper›PMID 33274497›Full record

ArticleJournal of clinical laboratory analysis2021

Research and discussion on the evaluation scheme of reagent lot-to-lot differences in 16 chemiluminescence analytes, established by the EP26-A guidelines of the CLSI.

Ran Tao, Chenli Zhang, Min Liu, Miao Yang, Wenying Gao, Jianbo Chen, Nanxun Mo, Yating Cheng, Jun He, Qin Xie

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical laboratory analysis, 2021. 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
–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

2 citing papers in PubMed.

  1. Review
  2. 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

10 authors.

Ran TaoLaboratory Diagnosis Department, Guangzhou Kingmed Center for Clinical Laboratory, Guangzhou, China.ORCID https://orcid.org/0000-0003-1126-6050
Chenli ZhangLaboratory Diagnosis Department, Taiyuan Kingmed Center for Clinical Laboratory, Taiyuan, China.
Min LiuLaboratory Diagnosis Department, Taiyuan Kingmed Center for Clinical Laboratory, Taiyuan, China.
Miao YangLaboratory Diagnosis Department, Taiyuan Kingmed Center for Clinical Laboratory, Taiyuan, China.
Wenying GaoLaboratory Diagnosis Department, Taiyuan Kingmed Center for Clinical Laboratory, Taiyuan, China.
Jianbo ChenLaboratory Diagnosis Department, Guangzhou Kingmed Center for Clinical Laboratory, Guangzhou, China.
Nanxun MoLaboratory Diagnosis Department, Guangzhou Kingmed Center for Clinical Laboratory, Guangzhou, China.
Yating ChengLaboratory Diagnosis Department, Guangzhou Kingmed Center for Clinical Laboratory, Guangzhou, China.
Jun HeLaboratory Diagnosis Department, Guangzhou Kingmed Center for Clinical Laboratory, Guangzhou, China.
Qin XieLaboratory Diagnosis Department, Changsha Kingmed Center for Clinical Laboratory, Changsha, China.

Funding

Guangdong Medical Science and Technology Research Fund A2020597
6 · The paper itself

Abstract

backgroundVerification of new reagent lots is a part of the crucial tasks in clinical laboratories. The Clinical and Laboratory Standards Institute (CLSI) EP26-A guideline provides laboratories with an evaluation method for reagent verification. The purpose of this study was to compare the performance of EP26-A with our laboratory reagent lot verification protocol and get the final scheme.

method16 chemiluminescence analytes including estradiol (E2), progesterone (P), ferritin (FER), cortisol (COR),carbohydrate antigen 153 (CA153), and free prostate-specific antigen (FPSA). were prospectively evaluated in two reagent lots. The laboratory's lot verification process included evaluating 5 patient samples with the current and new lots and acceptability according to a predefined criteria. For EP26-A, method imprecision data and critical differences at medical decision points were important factors affecting the sample size requirements and rejection limits.

resultThe number of samples required for EP26-A was 3 to 12, of which P, CA153, and FPSA had increased by more than 5 samples compared with the current protocol. Of the 16 chemiluminescence analytes, 11 had higher rejection limits when using EP26-A than the current laboratory scheme. Our current protocol and EP26-A were in agreement in 32 of the 32 (100%) paired verifications.

conclusionThe EP26-A protocol is an important tool to find the differences between reagent lots, and it makes up for the loopholes in the statistical efficiency, sample concentration and quantity, and the selection of rejection limits in the current protocol.

Indexed as

Antigens, NeoplasmBlood Chemical AnalysisClinical Laboratory ServicesEstradiolFerritinsGuidelines as TopicHumansHydrocortisoneIndicators and ReagentsLuminescent MeasurementsProgesteroneQuality ControlAntigens, NeoplasmCA153 protein, humanEstradiolFerritinsHydrocortisoneIndicators and ReagentsProgesteronechemiluminescence analyteCLSI EP26-Alot verification

Identifiers

PMID33274497
PMCPMC7957972

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.