This company has received FDA clearance to market Access Testosterone, an assay for the quantitative determination of total testosterone levels in human serum and plasma.
The assay, available for the Access Immunoassay System, is designed to assist in the management of patients with fertility disorders, sexual dysfunction, tumors or other medical conditions. The analytical sensitivity of the test is 0.1ng/mL with an assay range up to 16ng/mL.
The stability of the calibration curve is 14 days. The test exhibits less than 20 percent imprecision at 0.5ng/mL and less than 10 percent imprecision for higher concentrations of testosterone.
Other characteristics of the assay include results in down to 16 minutes, throughput up to 100 tests per hour, and reagent stability for one year if stored unopened at 2 to 10 degress Centigrade, or 28 days for opened reagents when stored at 2 to 10 degress Centigrade.
The test can be useful in commercial labs, medium-to-large-size hospitals, and endocrinology and fertility clinics. Each kit includes two reagent packs that each accommodate 50 tests.
Keyword: assay, testosterone