October 2015 Product Focus – Immunodiagnostics

bioMérieux’s VIDAS 3, the new generation of VIDAS, has received FDA 510(k) clearance. This instrument, which further enriches the offering of the VIDAS immunoassay product range, VIDAS and mini VIDAS, is now commercially available in the U.S. VIDAS 3 is CE marked and registered at the Chinese Food and Drug Administration (CFDA), which makes it available to clinical labs on a global scale. VIDAS 3 features enhanced automation, in particular the pre-analytical section from the bar-coded primary tube including dilution, improved traceability, and new software capabilities, as well as a quality control program in compliance with laboratory certification standards. Designed with the help of 1,500 immunoassay laboratories, VIDAS 3 reinforces the ease of use of the VIDAS range. This low-throughput immunoassays platform can perform tests on demand, individually or in series, 24 hours a day and seven days a week. As a result, it is suited to centralized as well as satellite laboratories, offering both versatility and reliability to healthcare professionals. VIDAS 3 uses the same reagents as the other instruments in the VIDAS range. At launch in the U.S., the VIDAS 3 menu features specialty and high-medical value tests, such as VIDAS B·R·A·H·M·S PCT for the management of septic patients. The single test concept and new features make the  VIDAS 3 well adapted to meet the needs of labs supporting Emergency Departments and Critical Care. For more information, please visit: http://www.biomerieux.com/en/biomerieux-receives-fda-510k-clearance-vidasr-3-new-generation-vidasr#sthash.pus0slOc.dpuf

Tosoh Bioscience, Inc.’s ST  AIA-PACK SHBG Assay

Tosoh Bioscience, Inc., introduces the ST AIA-PACK SHBG  assay for use on Tosoh AIA System Analyzers. The SHBG  assay is intended for use as an aid in the diagnosis of androgen disorders. Utilizing Tosoh’s unit dose test cup reagent technology, ST AIA-PACK SHBG has an assay time of approximately 18 minutes. Single, unitized test cups require no pre-mixing, no pre-measuring, and no on-board refrigeration. Dry reagent format ensures 90-day calibration stability for minimal waste and cost-effective testing. Test cups are bar-coded for easy identification and inventory management. ST AIA-PACK SHBG is designed for In Vitro Diagnostic Use Only for the quantitative measurement of Sex Hormone Binding Globulin (SHBG) in human serum or Na heparinized plasma on TOSOH AIA System  Analyzers. The ST AIA-PACK SHBG has an assay range of 0.2 to 250 nmol/L. The 90 days calibration stability makes it feasible to run this test even with low volumes. Sex hormone-binding globulin (SHBG) is glycoprotein that binds to the two sex hormones: androgen and estrogen. Androgens (e.g., testosterone) and estrogens (e.g., estradiol) circulate in the bloodstream, bound mostly to SHBG. Only a very small fraction (approx. 1%-2%) is unbound, or “free” and thus biologically active. SHBG inhibits the function of these hormones. Thus, bioavailability of sex hormones is influenced by the level of SHBG. SHBG is widely measured together with testosterone assays to calculate the “Free Androgen Index” (FAI), the ratio of total testosterone level derived by SHBG level. The FAI is known as a useful indicator to determine abnormal androgen status. For more information, please visit: http://www.diagnostics.us.tosohbioscience.com