【Product Name】Detection Kit for Testosterone (Tes) (Enhanced chemiluminescence immunoassay.)

【registration certificate number】 京食药监械（准）字2014第2400097号

       This kit is mainly used for quantitative determination of Testosterone (Tes)  in human serum in vitro.

Testosterone (Tes) is one of the most active hormones in androgens. The decrease of Tes in serum can reflect the male sexual dysfunction and secondary characteristics. The increase of Tes in serum is common found in benign testis interstitial cell tumor, true sexual precocity, increased cortisol, virilization tumors, congenital adrenal hyperplasia, female idiopathic hirsutism, testosterone or gonadotropin injection, obesity and advanced pregnant women, polycystic ovary syndrome.

       This kit uses competitive approach. Microplates were coated with Tes antibody to make a solid-phase antibody, calibrator of Tes (or sample to be tested) and HRP-Tes are added to the micropore coated with antibody, complex called Tes antibody-Tes and Tes antibody-HRP-Tes were formed. The binding amount of HRP-Pro is inversely proportional to the content of Pro in serum, the unbound HRP-Tes was removed after the immunoreaction, the luminescence was measured with a photon counter after adding the luminescent substrate. With the increase of Tes concentration, the luminescence value gradually decrease and keep a linear relation. Use double logarithm or other suitable fitting method and the instrument software will automatically calculate the Tes content of the sample.

1. High Sensitivity: chemiluminescence immuno assay can detect the substance that radioimmunoassay, enzyme-linked immunosorbent assay and other methods can not, early diagnosis of disease is of great significance.

2. Short Detection time: the optical signal measurement time of each sample is less than a second, which is very necessary for emergency situations in medical and health work (such as rescue, blood transfusion, emergency surgery, remote treatment, etc.).

3. Excellent stability: the validity period is up to one year, which is conducive to the popularization and application.

4. Simple and fast operation: Chemiluminescence immunoassay is simple and fast, the test can be completed one hour and projects commonly used can print report one hour.

5. Fast, good security: chemiluminescence immunoassay does not involve harmful chemical composition for human, although there are also waste exclusion, no harmful pollution to the environment.

          Women with high testosterone tend to have masculine features: long hair, thick hair, endocrine disorders, irregular menstruation, and enlarged pores.

Clinical laboratory, physical examination center.