Evidence map›Paper›PMID 33824232›Full record

ArticleAnnals of laboratory medicine2021

Internal Quality Control Data of Urine Reagent Strip Tests and Derivation of Control Rules Based on Sigma Metrics.

Haeil Park, Younsuk Ko

Abstract read
In one paragraph

Article in Annals of laboratory 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.

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0citing papers in PubMed
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1 · What the graph read from it

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2 · The registry

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3 · Its place in the literature

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0 citing papers in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

2 authors.

Haeil ParkDepartment of Laboratory Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.ORCID https://orcid.org/0000-0002-1092-0607
Younsuk KoDepartment of Laboratory Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.ORCID https://orcid.org/0000-0002-0120-8941

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUrine reagent strip test (URST) results are semi-quantitative; therefore, the precision of URSTs is evaluated as the proportion of categorical results from repeated measurements of a sample that are concordant with an expected result. However, URSTs have quantitative readout values before ordinal results challenging statistical monitoring for internal quality control (IQC) with control rules. This study aimed to determine the sigma metric of URSTs and derive appropriate control rules for IQC.

methodsThe URiSCAN Super Plus fully automated urine analyzer (YD Diagnostics, Yongin, Korea) was used for URSTs. Change in reflectance rate (change %R) data from IQC for URSTs performed between November 2018 and May 2020 were analyzed. Red blood cells, bilirubin, urobilinogen, ketones, protein, glucose, leukocytes, and pH were measured from 2-3 levels of control materials. The total allowable error (TE

resultsSeven out of the eight analytes had a sigma metric >4 in the control materials with a negative grade (-), which were closer to the cut-offs. Corresponding control rules ranged from 1

conclusionsAlthough the URST is a semi-quantitative test, statistical IQC can be performed using the readout values. According to the sigma metric, control rules recommended for URST IQC in routine clinical practice are 1

Indexed as

Reagent StripsTotal Quality ManagementUrinalysisIndicators and ReagentsQuality ControlSoftwareIndicators and ReagentsReagent StripsControl ruleInternal quality controlSigma metricUrine reagent strip test

Identifiers

PMID33824232
PMCPMC8041599

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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.