Intended use

This device is intended to be used for the in vitro quantitative determination of S100-beta (S100-β) in human serum or plasma. And it is for professional use only, not for self-testing of untrained individuals, nor for near-patient testing.

Summary

S100 is a 20 kDa protein belonging to the S100/calmodulin/troponin C superfamily of EF-hand calcium-binding proteins. S100 was originally isolated from human brain and considered a glial-cell specific protein. Today, 20 monomers of the S100 family have been identified based on structural and functional similarities. Most of the S100 proteins exist as dimers and are expressed in a cell-specific manner. Two of the S100 monomers, designated S100α and S100β are highly conserved between species and are found as homo- (ββ) and heterodimers (αβ) in central nervous system glial cells and in certain peripheral cells eg. Schwann cells, melanocytes, adipocytes, and chondrocytes. S100αβ and S100ββ are also present in malignant tissues, most notably in melanoma and to a lesser extent in glioma, thyroid cell carcinoma and renal cell carcinoma. Determination of S100β (like S100αβ and S100ββ units) in serum has been shown to be clinically useful for prognosis and treatment monitoring of patients diagnosed with malignant melanoma. Studies also suggest that S100β may be useful in the management of patients with brain damage from eg. traumatic head injury, perinatal asphyxia, cardiac arrest, cardiac surgery and stroke.

The current clinical methods for detecting S100-β include chemiluminescence, immunochromatography and so on.

PRODUCT PARAMETER

TEST INFORMATION
Method	Microfluidic Fluorescent Immunoassay	Test	LYOFIA® S100-β
Format	Cassette	Reaction Time	10min
Linearity	0.05～10 ng/mL	Reference Interval	＜0.2ng/mL
Sample	S / P	Certificate	CE

ORDERING
Cat. No.	LMCMSB25	Applicable analyzer	LYOFIA-I, LYOFIA 8,	Kit Size	25T
Cat. No.	LACMSB25	Applicable analyzer	LYOFIA 100 (Full-Automatic)	Kit Size	25T