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 Testosterone 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

Testosterone is an anabolic steroid hormone in the human body and the main component of androgen. The production and secretion of testosterone is closely related to age, and is mainly produced by Leydig cells (LCs). Its secretion is regulated by luteinizing hormone (LH), and has a negative feedback effect to the pituitary-hypothalamic regulatory mechanism. Testosterone promotes the formation of male secondary sexual characteristics and maintains the function of the prostate and seminal vesicles. The vast majority of circulating testosterone is bound to carrier proteins (eg sex hormone binding globulin - SHBG). A woman's ovaries produce small amounts of testosterone. Physiological concentrations of androgens have no specific effect on women. Elevated androgen levels in women can lead to virilization (depending on the degree of increase in androgen levels). Measuring testosterone levels in women can help diagnose androgen syndrome (AGS), polycystic ovaries (Stein-Leventhal syndrome), and can also help suspicion of ovarian tumors, adrenal tumors, adrenal dysplasia, or ovarian dysfunction. Measuring testosterone levels in men can be used to diagnose conditions where testosterone production is insufficient, such as hypogonadism, estrogen therapy, chromosomal abnormalities (eg, Klinefelter syndrome), and liver cirrhosis. Current clinical methods for detecting Testosterone include chemiluminescence method, immunochromatography method, and etc.

PRODUCT PARAMETER

TEST PARAMETER
Method	Microfluidic Fluorescent Immunoassay	Test	LYOFIA® Testosterone
Format	Cassette	Reaction Time	10min
Linearity	0.1～15ng/mL	Reference Interval	IFU
Sample	WB / S / P	Certificate	CE

ORDERING
Cat. No.	LMTHTE25	Applicable analyzer	LYOFIA-I, LYOFIA 8,	Kit Size	25T
Cat. No.	LATHTE25	Applicable analyzer	LYOFIA 100 (Full-Automatic)	Kit Size	25T