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First data on the biological variation and quality specifications for plasma ammonia concentrations in healthy subjects

  • Fatma Ucar EMAIL logo , Gonul Erden , Seyda Ozdemir , Nurgul Ozcan , Erdem Bulut and Alpaslan Ozturk
Published/Copyright: October 14, 2015
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 54 Issue 5

Abstract

Background:

Most of the factors causing preanalytical and analytical variation in ammonia measurement have been identified. Biological variation data for ammonia is still lacking. We therefore estimated the components of biological variation (within-subject=CVI and between-subject=CVG), reference change value (RCV) and quality specifications for ammonia in a group of healthy individuals using fresh and frozen plasma samples.

Methods:

Blood samples from 20 healthy subjects were collected in K2EDTA tubes daily over a period of 4 consecutive days from each subject. Each plasma sample was split into two aliquots; one was immediately analyzed as the samples were collected and the other was stored –80 °C until testing at the end of the collection period and analyzed at once in one analytical run. All samples were analyzed in duplicate. Estimations were calculated according to Fraser and Harris methods.

Results:

CVI value for fresh samples (13.78%) was significantly lower than that in frozen samples (18.91%) (p<0.001). However, there was no statistically significant difference in CVG values between fresh (16.91%) and frozen (18.43%) samples (p=0.570). The index of individuality did not exceed 1.4 for fresh and frozen samples. The estimated RCVs were high for both fresh and frozen samples (43.37% and 56.85%, respectively). Quality specifications were established.

Conclusions:

The present study for the first time described the components of biological variation for ammonia in healthy individuals. These data regarding biological variation of ammonia could be useful for a better evaluation of ammonia test results in clinical interpretation and for determining quality specifications based on biological variation.

Keywords: ammonia; between-subject biological variation; reference change value; within-subject biological variation
Corresponding author: Fatma Ucar, Department of Clinical Biochemistry, Diskapi Yildirim Beyazit Training and Research Hospital, Ankara 06110, Turkey, E-mail:

  1. Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Research funding: None declared.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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Received: 2015-6-24
Accepted: 2015-9-1
Published Online: 2015-10-14
Published in Print: 2016-5-1

©2016 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2015-0591
Keywords for this article
ammonia; between-subject biological variation; reference change value; within-subject biological variation

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Protein S100B: from cancer diagnostics to the evaluation of mild traumatic brain injury
  4. Reviews
  5. Capillary electrophoresis based on nucleic acid detection for diagnosing human infectious disease
  6. Oxidative damage and the pathogenesis of menopause related disturbances and diseases
  7. Opinion Paper
  8. EFLM WG-Preanalytical phase opinion paper: local validation of blood collection tubes in clinical laboratories
  9. Genetics and Molecular Diagnostics
  10. Effective quality management practices in routine clinical next-generation sequencing
  11. Analysis of PMP22 duplication and deletion using a panel of six dinucleotide tandem repeats
  12. A novel exonuclease (TaqMan) assay for rapid haptoglobin genotyping
  13. General Clinical Chemistry and Laboratory Medicine
  14. Heparinate but not serum tubes are susceptible to hemolysis by pneumatic tube transportation
  15. Criteria of adequacy for vitamin D testing and prevalence of deficiency in clinical practice
  16. A simple clot based assay for detection of procoagulant cell-derived microparticles
  17. Measurement of factor XIII (FXIII) activity by an automatic ammonia release assay using iodoacetamide blank-procedure: no more overestimation in the low activity range and better detection of severe FXIII deficiencies
  18. Immunoassay or LC-MS/MS for the measurement of salivary cortisol in children?
  19. Head to head evaluation of the analytical performance of two commercial methotrexate immunoassays and comparison with liquid chromatography-mass spectrometry and the former fluorescence polarization immunoassay
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