Package size

100 Tests, 50 Tests, 25 Tests, 10 Tests, 5 Tests, 100 Tests (N-QC), 50 Tests (N-QC), 25 Tests (N-QC), 10 Tests (N-QC), 5 Tests (N-QC).

Intended use

This device is intended to be used for the in vitro quantitative determination of 25-hydroxy Vitamin D (25-OH Vitamin D) in human whole blood, serum or plasma. And it is for professional use only, not for self-testing of untrained individuals, nor for near-patient testing.

Summary

Vitamin D, a fat-soluble steroid derivative, is an essential fat-soluble vitamin that can be converted into vitamin D2 after exposure to ultraviolet light. Cholesterol ingested by the human body or synthesized in the body is converted into 7-dehydrocholesterol and stored under the skin, and can be converted into vitamin D3 after ultraviolet irradiation. Vitamin D mainly comes in two forms, vitamin D3 (cholecalciferol) and vitamin D2 (ergocalciferol). Its levels are affected by many factors, mainly including UV radiation, dietary supplements, age and obesity, race and ethnicity. Vitamin D itself is not biologically active and requires 2 hydroxylation to convert it into a biologically active form. The first hydroxylation occurs in the liver to produce 25-hydroxyvitamin D, and the second hydroxylation occurs mainly in the kidney to produce the biologically active metabolite 1,25-dihydroxyvitamin D. When 1,25-(OH)2D is in sufficient amount, it can be further converted into 24,25-(OH)2D in the kidney, and finally catabolism occurs. The half-life of circulating 25-hydroxyvitamin D is 2-3 weeks. Therefore, in medicine, the detection of 25-hydroxyvitamin D in the blood is often used to determine the content of vitamin D in the body, and the concentration of 25-hydroxyvitamin D in the blood is considered to be the best indicator of the body's vitamin D status. Vitamin D has multiple biological roles. For example, it can promote calcium absorption in the small intestine; promote the reabsorption of calcium and phosphorus in renal tubules; regulate blood calcium balance; its metabolites are involved in a variety of bone metabolism pathways, etc. Vitamin D deficiency is closely related to the occurrence of many diseases, including bone diseases, autoimmune diseases and cardiovascular diseases; however excessive intake can cause diseases such as vitamin D excess and kidney stones. Therefore, it is of great significance to know the status of human vitamin D in time and realize individualized supplementation of vitamin D. Current clinical methods for detecting 25-OH Vitamin D include chemiluminescence method, immunochromatography method, and etc.

PRODUCT PARAMETER

TEST INFORMATION
Method	Microfluidic Fluorescent Immunoassay	Test	LYOFIA® 25-OH Vitamin D
Format	Cassette	Reaction Time	10min
Linearity	8～100ng/mL	Reference Interval	＞30ng/mL
Sample	S / P	Certificate	CE / NMPA

ORDERING
Cat. No.	LMGDVD25	Applicable analyzer	LYOFIA-I, LYOFIA 8,	Kit Size	25T
Cat. No.	LAGDVD25	Applicable analyzer	LYOFIA 100 (Full-Automatic)	Kit Size	25T