Analytical and clinical performance of the new Fujirebio 25-OH vitamin D assay, a comparison with liquid chromatography-tandem mass spectrometry (LC-MS/MS) and three other automated assays

作者：Saleh Lanja^*; Mueller Daniel; von Eckardstein Arnold

来源：Clinical Chemistry and Laboratory Medicine, 2016, 54(4): 617-625.

DOI：10.1515/cclm-2015-0427

• 25-hydroxy vitamin D
• immunoassays
• liquid chromatography-tandem mass spectrometry (LC-MS/MS)
• method comparison
• vitamin D assays

Background: We evaluated the analytical and clinical performance of the new Lumipulse (R) G 25-OH vitamin D assay from Fujirebio, and compared it to a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method and three other commercial automated assays.
Methods: Total 25 hydroxy vitamin D (25(OH) D) levels were measured in 100 selected serum samples from our routine analysis with Fujirebio 25(OH) D assay. The results were compared with those obtained with LC-MS/MS and three other automated 25(OH) D assays (Abbott, Beckman, and Roche). The accuracy of each assay tested was evaluated against a Labquality reference serum panel for 25(OH) D (Ref! 25OHD; University of Ghent).
Results: Intra-and inter-day imprecision of the Fujirebio 25(OH) D assay was < 5%. Fujirebio 25(OH) D assay showed the highest correlation among the assays tested with the LC-MS/MS method (R = 0.986). The mean relative bias obtained was -15.6% (Fujirebio), -12.7% (Beckman), -2.1% (Abbott) and 9.7% (Roche) as compared to LC-MS/MS. Comparison with the Labquality certified reference serum panel yielded a mean bias of -11.8% (Fujirebio), -14.1% (Beckman), 4.4% (Abbott) and 3.2% (Roche), respectively. Compared to LC-MS/MS, the sensitivity of different methods in detecting vitamin D insufficiency (< 50 nmol/L) varied from 100% for the Fujirebio assay to 72.7% for Roche, and specificity ranged from 94.4% for Roche to 87.6% for Beckman.
Conclusions: The Lumipulse G 25-OH vitamin D assay from Fujirebio demonstrated a good correlation with LC-MS/MS and some immunoassays. The performance of the assay is well-suited for routine 25(OH) D measurement in clinical serum samples. A correction for the observed negative bias vs. LC-MS/MS could be considered.

• 出版日期2016-4