Unit:
Κατεύθυνση Κλινική ΦαρμακευτικήLibrary of the School of Science
Author:
Koutsovasili Adamantia
Supervisors info:
Χαλιάσος Αλέξανδρος, Ιατρός-Κλινικός Χημικός, EurClinChem
Μαρκαντώνη- Κυρούδη Σοφία, Καθηγήτρια, Τμήμα Φαρμακευτικής, ΕΚΠΑ
Δρακούλης Νικόλαος, Αναπληρωτής Καθηγητής, Τμήμα Φαρμακευτικής, ΕΚΠΑ
Original Title:
Μελέτη σύγκρισης μεθόδων μέτρησης Βιταμίνης D και Παραθορμόνης με αυτοματοποιημένες ανοσοενζυμικές τεχνικές
Translated title:
Comparison study of Vitamin D and Parathormone assays with automated immunoenzyme techniques
Summary:
Background: Vitamin D deficiency is associated with an increased risk for many abnormal conditions, including osteoporotic fractures, cancer, diabetes, and on hypertension. For this reason, it was deemed necessary to quantify the levels of vitamin D and more specifically 25-hydroxyvitamin D [25(OH)D], which represents the levels of the vitamin D in the body. Thus, many laboratory assays and measurement tests have emerged to meet diagnostic needs related to vitamin D and parathyroid hormone (PTH). As there are limited data available comparing these methods, it is necessary to carry out comparison studies of the laboratory methods in order to establish the reliability of the measurements.
The aim of the study was to evaluate the differences in vitamin D and PTH measurements between the electrochemiluminescence immunoassay (ECLIA) method on the Roche Diagnostics cobas e411 analyzer and the chemiluminescence immunoassay (CLIA) on the Maglumi Diagnostics X3 analyzer.
Method: A total of 158 serum and plasma samples from adult, healthy subjects were collected for the study. Samples were centrifuged at 4°C and stored at -80°C until measured in the laboratory. Sample analysis was performed according to each manufacturer's protocol. Each sample was analyzed for 25(OH)D and PTH simultaneously. The measurements between the two methods were performed with one week interval.
Results: High inter-assay disagreement was found. In the ECLIA technique 25(OH)D levels were 30.07% (95% CI: 27.8 to 32.4) higher and PTH lower by 39.7% (95% CI: -42.3 to - 37.0) relative to the corresponding levels measured by the CLIA technique. Regression analysis between methods revealed a linear model (p>0.05) for both analytes.
Conclusions: There are significant differences in measurements between the two methods. The significance of vitamin D levels, but also of parathyroid hormone, are important for clinical practice. It is needed more studies to be established a global reference range for vitamin D and parathormone levels.
Main subject category:
Science
Other subject categories:
Health Sciences
Keywords:
vitamin D, parathormone, PTH, electrochemiluminescence immunoassay method, ECLIA, chemiluminescence immunoassay, CLIA
Number of references:
129
