Performance Evaluation of Elecsys Vitamin D Total II Assay Using Roche Modular Analytics E170.
10.15263/jlmqa.2018.40.2.109
- Author:
Eun Jung CHO
1
;
Hyunjung KIM
;
Jeongho PARK
;
Dongsik KIM
;
Youngjong CHA
;
Hae Kyung LEE
Author Information
1. Department of Laboratory Medicine, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Uijeongbu, Korea. hkl@cathlic.ac.kr
- Publication Type:Brief Communication
- Keywords:
Vitamin D;
Performance;
Evaluation
- MeSH:
Allergy and Immunology;
Humans;
Immunoassay;
Mass Spectrometry;
Methods;
Statistics as Topic;
Vitamin D*;
Vitamins*
- From:Journal of Laboratory Medicine and Quality Assurance
2018;40(2):109-111
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
We evaluated the performance of a recently developed immunoassay, Elecsys vitamin D total II assay (Roche Diagnostics GmbH, Germany). Precision, linearity, and comparison studies were performed according to the Clinical and Laboratory Standards Institute guidelines. Control materials, linearity materials, and patient samples were used for the evaluation. For the correlation study, liquid chromatography-tandem mass spectrometry was used as the comparative method. Total coefficients of variations of the analyte were between 5.1% and 9.6%. The results of linearity evaluation were also acceptable for the range tested. Correlations with comparative methods were good; however, the mean values of the Elecsys vitamin D assay were higher than those of liquid chromatography-tandem mass spectrometry. The overall analytical performance of the Elecsys vitamin D total II assay is acceptable for the immunology analyzer. Therefore, the Elecsys vitamin D total II assay is expected to be widely used.
