NIH, National Cancer Institute, Division of Cancer Treatment and Diagnosis (DCTD) NIH - National Institutes of Health National Cancer Institute DCTD - Division of Cancer Treatment and Diagnosis

Undisclosed interference in 25-OH-Vitamin D immunoassay on Liaison XL analyzer when using heparin plasma tubes.

Author(s): Jacobs J, Vanneste F, Hotton J, Miller N, Cauchie M, Brassinne L, Mairesse A

Publication: Scand J Clin Lab Invest, 2023, Vol. 83, Page 390-393

PubMed ID: 37504570 PubMed Review Paper? No

Purpose of Paper

 This paper compared vitamin D levels in case-matched serum and lithium heparin plasma specimens from randomly selected patients that were analyzed using two different auto-analyzers.

Conclusion of Paper

When analyzed using the Liaison XL analyzer, lithium heparin plasma had significantly higher vitamin D levels than case-matched serum, which resulted in a larger percentage of patients considered to have normal vitamin D levels and fewer patients characterized with vitamin D insufficiency or deficiency. In contrast, vitamin D levels were comparable among lithium heparin plasma and serum when analyzed on a Cobas e 801 analyzer and consequently lithium heparin plasma and serum specimens analyzed with a Cobas e 801 instrument generated similar percentages of patients considered to have normal vitamin D levels. Importantly, while serum levels of vitamin D were comparable when quantified on the two different analyzers, lithium heparin plasma vitamin D levels were higher when analyzed using the Liaison XL analyzer compared to the Cobas e 801.

Studies

  1. Study Purpose

    This study compared vitamin D levels in case-matched serum and lithium heparin plasma specimens that were analyzed using two different auto-analyzers. Blood was collected from 34 randomly selected patients (diagnosis not specified) into serum-gel and lithium-heparin plasma tubes. Lithium heparin plasma and serum were separated by centrifugation at 1,885 × g for 10 min, aliquoted, and stored frozen (temperature not specified) for 1 month. Vitamin D levels were quantified using an electro­chemiluminescence immunoassay on a Cobas e 801 autoanalyzer and a chemiluminescence immunoassay on a Liaison XL autoanalyzer.

    Summary of Findings:

    A larger percentage of patients were considered to have normal vitamin D levels when lithium heparin plasma was analyzed rather than serum using the Liaison XL analyzer (79% versus 64%) but not the Cobas e 801 analyzer (64% versus 67%). This corresponded to fewer patients characterized with vitamin D insufficiency or vitamin D deficiency when lithium heparin plasma was analyzed with a Liaison XL analyzer than serum (12% and 9%, respectively versus 15% and 21%, respectively). When the Cobas e 801 analyzer was used, a comparable percentage of serum and lithium heparin plasma specimens were characterized as vitamin D insufficient (12% and 15%, respectively) or vitamin D deficient (21%, both). The mean bias in the lithium heparin tubes relative to serum tubes was 57.5% (P<0.001) with the Liaison XL analyzer but only −0.2% with the Cobas e 801 analyzer.  Finally, vitamin D levels were significantly higher in lithium heparin plasma than serum when specimens were analyzed using the Liaison XL analyzer (P<0.001) and in lithium heparin plasma that was analyzed using the Liaison XL analyzer compared to lithium heparin plasma specimens that were analyzed on the Cobas e 801 analyzer (P<0.001).  However, no significant differences in vitamin D levels were found between lithium heparin plasma and serum specimens that were analyzed using Cobas e 801 analyzer or between serum analyzed using the two different analyzers.

    Biospecimens
    Preservative Types
    • Frozen
    Diagnoses:
    • Not specified
    Platform:
    AnalyteTechnology Platform
    Steroid Clinical chemistry/auto analyzer
    Pre-analytical Factors:
    ClassificationPre-analytical FactorValue(s)
    Biospecimen Acquisition Type of collection container/solution Serum-gel Vacutainer tube
    Lithium-heparin Vacutainer tube
    Clinical chemistry/auto analyzer Specific Technology platform Chemiluminescence immunoassay on a Liaison XL autoanalyzer
    Electrochemiluminescence immunoassay on a Cobas e 801 autoanalyzer
    Biospecimen Aliquots and Components Blood and blood products Plasma
    Serum

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