Evidence map›Paper›PMID 28594875›Full record

ArticlePloS one2017

Analytical evaluation of three enzymatic assays for measuring total bile acids in plasma using a fully-automated clinical chemistry platform.

Elisa Danese, Gian Luca Salvagno, Davide Negrini, Giorgio Brocco, Martina Montagnana, Giuseppe Lippi

Open access · goldAbstract readEvaluation Study
In one paragraph

Article in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.3field-weighted citation impact, top 18% 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

12 citing papers in PubMed, 33 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Application of AI on cholangiocarcinoma.Frontiers in oncology · 2024
    Review
  6. A simple and reliable bile acid assay in human serum by LC-MS/MS.Journal of clinical laboratory analysis · 2022
    Article
  7. Analytical performance and method comparison of a quantitative point-of-care immunoassay for measurement of bile acids in cats and dogs.Journal of veterinary diagnostic investigation : official publication of the American Association of Veterinary Laboratory Diagnosticians, Inc · 2021
    Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. A review of analytical platforms for accurate bile acid measurement.Analytical and bioanalytical chemistry · 2019
    Review
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

6 authors at 1 institution in 1 country.

Elisa DaneseSection of Clinical Biochemistry, University of Verona, Verona, Italy.ORCID http://orcid.org/0000-0002-2454-0410
Gian Luca SalvagnoSection of Clinical Biochemistry, University of Verona, Verona, Italy.
Davide NegriniSection of Clinical Biochemistry, University of Verona, Verona, Italy.
Giorgio BroccoSection of Clinical Biochemistry, University of Verona, Verona, Italy.
Martina MontagnanaSection of Clinical Biochemistry, University of Verona, Verona, Italy.
Giuseppe LippiSection of Clinical Biochemistry, University of Verona, Verona, Italy.
University of Verona · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough the clinical significance of measuring bile acids concentration in plasma or serum has been recognized for long in patients with hepatobiliary disease and/or bile acid malabsorption, the reference separation techniques are expensive and mostly unsuitable for early diagnosis and for measuring large volumes of samples. Therefore, this study was aimed to evaluate the analytical performance of three commercial enzymatic techniques for measuring total bile acids in plasma using a fully-automated clinical chemistry platform.

methodsThree commercial enzymatic assays (from Diazyme, Randox and Sentinel) were adapted for use on a Cobas Roche c501. We performed imprecision and linearity studies, and we compared results with those obtained using a reference liquid chromatography-mass spectrometry (LC-MS) technique on an identical set of lithium-heparin plasma samples.

resultsTotal imprecision was optimal, always equal or lower than 3%. All assays had optimal linearity between 3-138 μmol/L. The comparison studies showed good correlation with LC-MS data (Spearman's correlation coefficients always >0.92), but all plasma samples values were significantly underestimated using the commercial enzymatic assays (-44% for Diazyme, -16% for Randox and -12% for Sentinel). The agreement at the 10 and 40 μmol/L diagnostic thresholds of total bile acids in plasma ranged between 86-92%. This discrepancy was found to be mainly attributable to a heterogeneous composition in terms of bile acids content of the three assay calibrators.

conclusionsThis study suggests that the analytical performance of the three commercial enzymatic assays is excellent, thus confirming that automation of this important test by means of enzymatic assessment may be feasible, practical, reliable and supposedly cheap. Nevertheless, the underestimation of values compared to the reference LC-MS also suggests that the local definition and validation of reference ranges according to the combination between the specific enzymatic assay and the different clinical chemistry platforms may be advisable.

Indexed as

AutomationBile Acids and SaltsCalibrationChemistry, ClinicalChromatography, LiquidEnzyme AssaysHumansMass SpectrometryReagent Kits, DiagnosticStatistics, NonparametricBile Acids and SaltsReagent Kits, Diagnostic

Identifiers

PMID28594875
PMCPMC5464614
OpenAlexW2622176663

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LicenceCC BY
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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.