VITAMIN DAssay

Clinical Systems

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CLINICAL INFORMATIONVitamin D is a fat-soluble steroid hormone that is strongly linked with active intestinal absorption of calcium, in the regulation of plasma calcium homeostasis and, as well, imparting some protection against rickets and osteomalacia.

There are two important forms of vitamin D, D3 and D2. Vitamin D3 is obtained from skin exposure to sunlight (UVA and UVB). Vitamin D3 and D2 can also be absorbed from food and/or vitamin supplements. Subsequent hydroxylation reactions result in the active hormone 1,25 dihydroxy vitamin D.

The pro-hormone, 25 hydroxy vitamin D (25-OHD) is the predominant circulating form of vitamin D. As such, serum or plasma 25-OHD is considered to be an accurate and reliable indicator of the overall vitamin D status of an individual.

The sum of the concentrations of 25-OHD formed from vitamin D2 and D3, in serum or plasma, is referred to as “Total 25-OHD”. Vitamin D defi ciency has been linked to many diseases including osteoporosis, rickets, and osteomalacia, so accurate monitoring of Total 25-OHD in serum and plasma is becoming increasingly important in clinical settings.

INTENDED USE*ELITech Clinical Systems VITAMIN D is an in vitro diagnostic reagent intended for the quantitative determination of Total Vitamin D in human serum and plasma samples.

PERFORMANCE ON SELECTRA PRO SERIESMETHOD Latex Immunoturbidimetric Assay

CONFIGURATION 2 part ready to use Stable Liquid reagent

SAMPLE TYPE Serum - Plasma

TRACEABILITY NIST SRM972a

MEASURING RANGE 19.0 to 369.5 nmol/L (7.6 to 147.8 ng/mL)

ON-BOARD STABILITY 28 days

CALIBRATION FREQUENCY STABILITY 7 days

PRECISION Test Levels Within-run CV Total CV

57.3 nmol/L (22.9 ng/mL) 1.7 % 4.3 %109.8 nmol/L (43.9 ng/mL) 0.4 % 2.6 %220.3 nmol/L (88.1 ng/mL) 0.9 % 3.5 %

ORDERING INFORMATIONREFERENCE DESIGNATION KIT SIZE EQUIPMENT SYSTEM PACK

REAGENT VITD-0230 VITAMIN D R1 2 x 21 mL / R2 2 x 5 mL Selectra Pro Series (202 Tests per kit)

CALIBRATOR VITD-0043 VITAMIN D CALIBRATOR SET 5 x 1 mL

CONTROL VITD-0049 VITAMIN D CONTROL SET 2 x 3 mL

ECS

VITD

10/

2019

/001

Individual Test vs Mean Comparative150

120

90

60

30

3000

9060 150120

Competitor Method (ng/mL)

ELIT

ech

Clin

ical

Sys

tem

s M

etho

d (n

g/m

L)y = 1.002x + 0.6

R = 0.99

ELITech Clinical Systems SAS (France)

* Read carefully information available on labelling and/or on the instructions for use.

Clinical Systems