J Bone Metab.  2015 Aug;22(3):107-112. 10.11005/jbm.2015.22.3.107.

Discrepancy between Vitamin D Total Immunoassays due to Various Cross-reactivities

• Lee JH
• Choi JH
• Kweon OJ
• Park AJ

• KMID: 2170106
• DOI: http://doi.org/10.11005/jbm.2015.22.3.107

Abstract

BACKGROUND
The purpose of this study was to find out the cause of discrepancy between various automated immunoassays for 25-hydroxy-vitamin D (25-[OH]D).
METHODS
National Institute of Standards & Technology Standard Reference Material (SRM) 972a is SRM for 25-(OH)D and consists of 4 vials of frozen serum with different concentrations of 25-(OH)D. Each concentration was measured 6 times in 3 different immunoassays: ADVIA Vitamin D Total assay (Siemens Healthcare, Erlangen, Germany), ARCHITECT 25-(OH)D (Abbott Laboratories, Abbott Park, IL, USA), and COBAS Vitamin D Total assay (Roche Diagnostics, Basel, Switzerland).
RESULTS
When using the certified reference values of SRM 972a as it is, discarding the cross-reactivity of each immunoassay, for ADVIA, the coefficient of determination (R2) as a score of regression analysis was 0.8995 and maximal difference between measured value and certified reference value was 3.6 ng/mL in level 3. The R2 and maximal differences of ARCHITECT were 0.5377 and 6.9 ng/mL, respectively, in level 4. Those of COBAS were 0.3674 and 22.3 ng/mL, respectively, in level 4. When considering cross-reactivities of each immunoassays to various 25-(OH)D metabolites, the ADVIA had R2 and maximal difference of 0.9254 and 3.3 ng/mL, respectively, in level 3. For ARCHITECT, the R2 and maximal differences were 0.7602 and 5.1 ng/mL, respectively, in level 1. Those of COBAS were 0.9284 and 4.9 ng/mL, respectively, in level 1.
CONCLUSIONS
The cause of discrepancies between vitamin D immunoassays was mainly on the difference in cross-reactivities to various vitamin D metabolites. The discrepancies can be considerably decreased by considering cross-reactivities of each immunoassay.

Keyword

Cross reactions; Immunoassay; Reference standards; Vitamin D

MeSH Terms

Cross Reactions
Delivery of Health Care
Immunoassay*
Reference Values
Vitamin D*
Vitamins*
Vitamin D
Vitamins

Figure

• 

  Fig. 1 Regression plots between reference values and measured values of Standard Reference Material (SRM) 972a. (A) and (B) are of ADVIA (Siemens), (C) and (D) are of ARCHITEC (Abbott), (E) and (F) are of COBAS (Roche). X axis means reference values of SRM 972a in (A), (C), and (E); while X axis means corrected reference values for cross-reactivity in (B), (D), and (F).

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