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Analytical validation of the Roche 25-OH Vitamin D Total assay

  • Cindy Soendersoe Knudsen EMAIL logo , Ebba Nexo , Carsten Schriver Højskov und Lene Heickendorff
Veröffentlicht/Copyright: 27. Juli 2012
Clinical Chemistry and Laboratory Medicine (CCLM)
Aus der Zeitschrift Clinical Chemistry and Laboratory Medicine (CCLM) Band 50 Heft 11

Abstract

Background: Vitamin D deficiency is considered a major health issue and therefore there is a need for reliable routine tests for measurement of the vitamin in blood samples. Here we present a validation of the recently released Roche 25-OH Vitamin D Total assay (Vitamin D Total).

Methods: We analyzed control materials (2 levels) and patient serum pools (3 levels) ranging from 34 to 123 nmol/L 84 times over a period of 21 days, and we analyzed five serum pools in 10 separate runs to verify the limit of quantification. We also analyzed 53 paired samples of serum and Li-heparin plasma. We evaluated the 25-OH Vitamin D Total assay in comparison to our in-house liquid chromatography tandem mass spectrometry (LC-MS/MS) method [194 patient samples without 25-hydroxy vitamin D2 (25OHD2) and 23 patient samples containing 25OHD2].

Results: At concentrations of 34 and 56 nmol/L within-run CVs were 4.8% and 1.9% and total CVs were 8.3% and 6.1%. We verified that the limit of quantification was 22.5 nmol/L, as stated by the manufacturer. No significant difference was observed between serum and plasma samples (Li-heparin). Comparison with LC-MS/MS using 194 samples containing 25OHD3 only (no 25OHD2) showed Vitamin D Total nmol/L=1.07×(LC-MS/MS) nmol/L+4.7 nmol/L, whereas comparison of 25OHD2 using 23 patient samples showed Vitamin D Total nmol/L=0.55×(LC-MS/MS) nmol/L–2.38 nmol/L (Demings regression).

Conclusions: The Roche Vitamin D Total assay is judged suitable for measurement of 25OHD in serum and Li-heparin plasma. Results for 25OHD3 are comparable to those obtained by LC-MS/MS, while results for 25OHD2 are around half of those obtained by LC-MS/MS.

Keywords: assay precision; assay validation; 25-hydroxyvitamin D; method comparison
Corresponding author: Cindy Soendersoe Knudsen, Department of Clinical Biochemistry, Aarhus University Hospital, Norrebrogade 44, 8000 Aarhus C, Denmark Phone: +45 7846 3077, Fax: +45 7846 3060
Received: 2011-12-30
Accepted: 2012-06-13
Published Online: 2012-07-27
Published in Print: 2012-11-01

©2012 by Walter de Gruyter Berlin Boston

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  34. Letters to the Editor
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https://doi.org/10.1515/cclm-2011-0964
Schlagwörter für diesen Artikel
assay precision; assay validation; 25-hydroxyvitamin D; method comparison

Artikel in diesem Heft

  1. Congress Abstracts
  2. 44th National Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology
  3. Masthead
  4. Masthead
  5. Editorials
  6. Tumor biomarkers: PSA and beyond
  7. Error reporting in transfusion medicine: an important tool to improve patient safety
  8. The measurement of 25-hydroxy vitamin D – an analytical challenge
  9. Reviews
  10. Kallikrein-related peptidases (KLKs): a gene family of novel cancer biomarkers
  11. Exhaled breath analysis for early cancer detection: principle and progress in direct mass spectrometry techniques
  12. γ′ Fibrinogen as a novel marker of thrombotic disease
  13. Mini Review
  14. Revaluating serum ferritin as a marker of body iron stores in the traceability era
  15. Genetics and Molecular Diagnostics
  16. Association of PBEF gene polymorphisms with acute lung injury, sepsis, and pneumonia in a northeastern Chinese population
  17. General Clinical Chemistry and Laboratory Medicine
  18. Brazilian laboratory indicators program
  19. Error reporting in transfusion medicine at a tertiary care centre: a patient safety initiative
  20. Application of mathematical models of system uncertainty to evaluate the utility of assay calibration protocols
  21. 25-Hydroxyvitamin D testing: challenging the performance of current automated immunoassays
  22. Analytical validation of the Roche 25-OH Vitamin D Total assay
  23. The new Roche Vitamin D Total assay: fit for its purpose?
  24. Improvement of a prenatal screening program for trisomy 18 in the first trimester of gestation
  25. Stability of osteopontin in plasma and serum
  26. Is there a suitable point-of-care glucose meter for tight glycemic control? Evaluation of one home-use and four hospital-use meters in an intensive care unit
  27. Cancer Diagnostics
  28. Rapid elimination kinetics of free PSA or human kallikrein-related peptidase 2 after initiation of gonadotropin-releasing hormone-antagonist treatment of prostate cancer: potential for rapid monitoring of treatment responses
  29. Detection of frequent ABCB1 polymorphisms by high-resolution melting curve analysis and their effect on breast carcinoma prognosis
  30. Cardiovascular Diseases
  31. The combined use of neutrophil gelatinase-associated lipocalin and brain natriuretic peptide improves risk stratification in pediatric cardiac surgery
  32. Association of the atherogenic index of plasma and oxidative stress status with weight gain during non-complicated pregnancy
  33. The high-sensitivity cardiac troponin T assay is superior to its previous assay generation for prediction of 90-day clinical outcome in ischemic stroke
  34. Letters to the Editor
  35. Evaluation of the cross-reactivity of 25-hydroxyvitamin D2 on seven commercial immunoassays on native samples
  36. Measurement of 25-hydroxyvitamin vitamin D by liquid chromatography tandem-mass spectrometry with comparison to automated immunoassays
  37. Analytical evaluation of a new automated protein binding assay to determine 25-hydroxyvitamin D concentrations
  38. Mindray BS-800M1: a new clinical chemistry system with a flexible technology meeting quality performances
  39. Association of urinary albumin and serum high molecular weight-adiponectin with metabolic syndrome in patients with essential hypertension
  40. Measurement of nitrite in plasma and serum: still a challenging analytical task
  41. Association between serum γ-glutamyltransferase and pulmonary dysfunction
  42. Serum ferritin concentrations predict incidence of metabolic syndrome in rural Korean adults
  43. Homocysteine, folic acid and vitamin B12 levels in females with severe acne vulgaris
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