Intended use

This device is intended to be used for the in vitro quantitative determination of alpha-fetoprotein (AFP) 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

Alpha-Fetoprotein (AFP) is normally produced during fetal and neonatal development by the liver, yolk sac and in small concentrations by the gastrointestinal tract. By the second year of life, AFP concentrations decrease rapidly, and thereafter only trace

amounts are normally detected in serum. In general, normal adults have serum AFP concentrations of less than 10ng/ml. Elevated AFP levels occur in several malignant diseases including hepatocellular carcinoma, testicular nonseminomatous origin, and occasionally of other entodermal origin. AFP has also been used to detect early tumors in people at high risk for liver cancer. Studies of patients with large hepatic metastases or viral hepatitis also indicate slightly elevated or persistent AFP values. In areas where liver cancer is common, the use of AFP tests for screening has resulted in the detection of many tumors at an earlier stage. 6 Detection of elevated AFP levels can also be used in the detection of fetal open neural tube defects.

The current clinical methods for detecting AFP include chemiluminescence, immunochromatography and so on.

PRODUCT PARAMETER

TEST INFORMATION
Method	Microfluidic Fluorescent Immunoassay	Test	LYOFIA® AFP
Format	Cassette	Reaction Time	10min
Linearity	[5,400] pg/mL	Reference Interval	＜20ng/mL
Sample	S / P	Certificate	CE

ORDERING
Cat. No.	LMTMAF25	Applicable analyzer	LYOFIA-I, LYOFIA 8,	Kit Size	25T
Cat. No.	LATMAF25	Applicable analyzer	LYOFIA 100 (Full-Automatic)	Kit Size	25T