Evidence map›Paper›PMID 32063730›Full record

ArticleBiochemia medica2020

Test validation, method comparison and reference range for the measurement of β-hydroxybutyrate in peripheral blood samples.

Frank Bernhard Kraus, Marija Kocijancic, Alexander Kluttig, Beatrice Ludwig-Kraus

Open access · diamondAbstract readComparative StudyValidation Study
In one paragraph

Article in Biochemia medica, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.7field-weighted citation impact, top 31% 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

7 citing papers in PubMed, 12 citations in OpenAlex.

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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

4 authors at 2 institutions in 1 country.

Frank Bernhard KrausCentral Laboratory, University Hospital Halle, Halle (Saale), Germany.
Marija KocijancicCentral Laboratory, University Hospital Halle, Halle (Saale), Germany.
Alexander KluttigInstitute of Medical Epidemiology, Biostatistics and Informatics, Martin-Luther- University Halle-Wittenberg, Halle (Saale), Germany.
Beatrice Ludwig-KrausCentral Laboratory, University Hospital Halle, Halle (Saale), Germany.
Martin Luther University Halle-Wittenberg · DEUniversity Hospital in Halle · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe measurement of β-hydroxybutyrate (βOHB) concentrations is a corner stone of the diagnosis of diabetic ketoacidosis and other ketonic states. The aim of this study was to perform a validation of a peripheral blood βOHB assay (Randox) on a Roche cobas c502 analyser and to establish a βOHB reference range for the validated assay. MATERIALS AND

methodsPrecision, linearity and limit of detection and blank (LoD, LoB) were determined according to Clinical and Laboratory Standards Institute (CLSI) EP05-A3, EP 06-A and EP17-A2 guidelines, using commercial control material and residual patient sample pools. As method comparison, for 190 semi-quantitative measurements of urine ketones we determined the corresponding βOHB blood concentration. The reference range was based on the CLSI C28-A3 guideline, using 304 randomly selected serum samples from population based German National Cohort (GNC) study.

resultsCoefficients of variation for the validated assay ranged from 1.5% for high concentrations (3.1 mmol/L) to 6.5% for low concentrations (0.1 mmol/L). Detection capacity was LoB = 0.011 mmol/L and LoD = 0.037 mmol/L. Linearity of the assay ranged from 0.10 to 3.95 mmol/L. The agreement between the semi-quantitative urine ketone test and the βOHB blood test was moderate (Kappa = 0.66). The obtained 95% serum reference range was estimated as 0.02 to 0.28 mmol/l βOHB.

conclusionsThe Ranbut βOHB assay showed good precision and analytical performance. Our results confirm that βOHB measurement in peripheral blood is indeed a preferable alternative to the semi-quantitative measurement of urine ketones.

Indexed as

3-Hydroxybutyric AcidBlood Chemical AnalysisDiabetic KetoacidosisHumansReference Values3-Hydroxybutyric Acidketoacidosismethod validationreference rangeurine ketonesβ-hydroxybutyrate

Identifiers

PMID32063730
PMCPMC6999181
OpenAlexW3006531009

What OpenQuestion holds

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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.