Automated measurement of 25-OH Vitamin D on the LUMIPULSE®G1200: analytical verification and method comparison. Issue 3 (2nd July 2016)

• Record Type: Journal Article
• Authors: Parra, Marina; Foj, Laura; Filella, Xavier
• Is Part Of: British journal of biomedical science. Volume 73:Issue 3(2016)
• Page Start: 104
• Page End: 109
• Publication Date: 2016-07-02
• Subjects: 25-Hydroxyvitamin D3 -- 25-Hydroxyvitamin D2 -- immunoassay -- automation; Medical sciences -- Periodicals; Medical technology -- Periodicals; Biological Science Disciplines; Clinical Laboratory Techniques; Medical Laboratory Science; Anatomie pathologique; Medical sciences; Medical technology; Klinische chemie; Laboratoriumonderzoek; Periodicals; Periodicals; 616.0756; 610.07 M489L
• DOI: 10.1080/09674845.2016.1188478
• Languages: English
• ISSNs: 0967-4845

Abstract

Abstract: Background: Because of its potential value in several pathologies, clinical interest in 25-hydroxy Vitamin D (25OH-D) is increasing. However, the standardisation of assays remains a significant problem. Our aim was to evaluate the performance of the novel Lumipulse G 25-OH Vitamin D assay (Fujirebio), comparing results with the Liaison (Diasorin) method. Methods: Analytical verification of the Lumipulse G 25-OH Vitamin D assay was performed. Both methods were compared using sera from 226 patients, including 111 patients with chronic renal failure (39 on haemodialysis) and 115 patients without renal failure. In addition, clinical concordance between assays was assessed. Results: For Lumipulse G 25-OH Vitamin D assay, the limit of detection was 0.3 ng/mL, and the limit of quantification was 2.5 ng/mL with a 9.7% of coefficient of variation. Intra-and inter-assay coefficients of variation were <2.3 and <1.8% (25.4–50.0 ng/mL), respectively. Dilution linearity was in the range of 4.5–144.5 ng/mL. Method comparison resulted in a mean difference of −6.5% (95% CI from −8.8 to −4.1) for all samples between Liaison and Lumipulse G . Clinical concordance assessed by Kappa Index was 0.66. Conclusions: Lumipulse G 25-OH Vitamin D showed a good clinical concordance with the Liaison assay, although overall results measured in Lumipulse were higher by an average of 6.5%.