Performance evaluation of Siemens ADVIA Centaur and Roche MODULAR Analytics E170 Total 25-OH Vitamin D assays.
OBJECTIVE
To evaluate the newly developed Roche MODULAR Analytics E170 Total Vitamin D and the Siemens ADVIA Centaur Vitamin D Total assays.


METHODS
Assays were evaluated using the Clinical and Laboratory Standards Institute protocols. Split patient samples were compared with LC-MS/MS and DiaSorin LIAISON assays (n=79 including 15 specimens with detectable endogenous 25-OH vitamin D(2)). Assay accuracy was also evaluated using the Vitamin D External Quality Assessment Scheme (DEQAS) samples.


RESULTS
The ADVIA Centaur and E170 assays demonstrated maximum total CVs of 14.1% and 5.9%, respectively. Both showed excellent linearity (R(2)>0.99). The ADVIA Centaur assay demonstrated interference with bilirubin at 800 μmol/L, hemolysis at 1.25 g/L, and triglycerides at 2.8 mmol/L. Compared to LC-MS/MS, the ADVIA Centaur assay demonstrated a R(2) value of 0.893, average bias of -8.8%; the E170 assay an R(2) value of 0.872, average bias of 14.3% with underestimation of 25-OH vitamin D(2). Compared to the LIAISON assay, the ADVIA Centaur assay demonstrated an R(2) value of 0.781, average bias of -17.3%; the E170 assay an R(2) value of 0.823, average bias of 11.4%. The ADVIA Centaur and E170 assays demonstrated a biases of <20% in 10/10 and 8/10 DEQAS samples, respectively.


CONCLUSIONS
The ADVIA Centaur and E170 vitamin D assays demonstrated acceptable linearity, imprecision, and accuracy. The E170 assay demonstrated consistent underestimation of 25-OH vitamin D(2) levels. Compared with LC-MS/MS, the ADVIA Centaur assay demonstrated a higher R(2) value and a smaller average bias than the E170 assay.
Division of Clinical Biochemistry, Department of Laboratory Medicine, Dr. Everett Chalmers Regional Hospital, Horizon Health Network, Fredericton, New Brunswick, Canada E3B 5N5. yu.chen@horizonNB.ca
Yu
Y
Chen
Lois
L
Kinney
Andrea
A
Božović
Hilary
H
Smith
Heather
H
Tarr
Eleftherios P
EP
Diamandis
Adrien
A
LeBlanc
D001774:Blood Chemical Analysis / Q000295:instrumentation* / Q000592:standards; D002762:Cholecalciferol / Q000097:blood*; D004872:Ergocalciferols / Q000097:blood*; D006801:Humans; D057230:Limit of Detection; D016014:Linear Models; D012015:Reference Standards; D059629:Signal-To-Noise Ratio; D053719:Tandem Mass Spectrometry
D004872:Ergocalciferols; D002762:Cholecalciferol