Prostrate Cancer System

Determines rate of change of serum tPSA over time

The Iris Personalized Medicine group, IRIS International Inc, Chatsworth, Calif, introduces its prostate cancer system, NADiA ProsVue, an in vitro diagnostic assay for determining rate of change of serum total prostate specific antigen (tPSA) over a period of time. A retrospective clinical study of 304 patients evaluated the slope of three successive ProsVue tests over a period of at least 10 months after a prostatectomy to identify prostate cancer patients with no evidence of disease or clinical progression. Recurrence of disease was determined by positive imaging, biopsy results, or prostate cancer-related death. The study resulted in a negative predictive value, or the proportion of patients correctly identified as stable, of 92.7%, and a positive predictive value, or proportion of patients correctly identified as recurring, of 78.0%. Consequently, a ProsVue slope of equal to or less than 2.0 pg/mL per month in the first year following radical post-prostatectomy was highly associated with no evidence of disease over the long-term follow-up. The NADiA ProsVue received 510(k) clearance from the FDA and CE Mark approval in the fall of 2011.

IRIS International Inc
(877) 920-4747
www.proiris.com


HbA1c Linearity/Calibration Verification Material

Used to assess instrument accuracy

Streck Inc, Omaha, Neb, introduces A1c-Cellular® Linearity, a commercially available Hemoglobin A1c (HbA1c) linearity/calibration verification material with intact red blood cells. A1c-Cellular Linearity is a five-level assayed linearity material used to assess instrument accuracy and verify the patient reportable range of the HbA1c parameter. The product’s unique formulation does not require reconstitution, reducing the potential for human errors and saving time. The Streck linearity material tests the entire reportable range of the instrument system, including the lyse step. Instrument-specific target values and expected ranges are provided for immediate instrument accuracy verification. Streck’s A1c-Cellular Linearity is assayed for the Abbott Architect® c Systems; Beckman Coulter Synchron CX®/LX® and UniCel DxC® 600/800 Synchron®; Bio-Rad Variant II™, Variant II™ Turbo and D-10™; Ortho-Clinical Diagnostics VITROS® 5, 1 FS and VITROS® 5600; Roche COBAS Integra® and Cobas® 6000; Siemens Dimension Series; and Tosoh G7/G8. A1c-Cellular Linearity features 7-day open-vial stability and 105-day closed-vial stability. Cap-pierceable vials offer convenience of auto sampling for analyzers with those capabilities, and bar codes for instruments capable of bar code scanning.

Streck Inc
(800) 843-0912
www.streck.com


Vitamin D Control

Formulated with real human serum

Quantimetrix, Redondo Beach, Calif, introduces Complete D 25-OH Vitamin D Control, an FDA-cleared, ready-to-use liquid control. Developed and manufactured by Quantimetrix, Complete D is formulated with real human serum containing 25-OH Vitamin D2 and D3. It has a 2-year refrigerated shelf life from the date of manufacture and 1-year open-vial stability when stored at 2° to 8°C or 30 days at room temperature. Values are traceable to the NIST standard SRM 972. Data is provided for LC-MS-MS, Diasorin Liaison, IDS-Direct EIA, IDS-RIA, and LC-MS-MS isotope dilution methods. Packaged in two levels, 3x3 mL per box.

Quantimetrix
(800) 624-8380
www.quantimetrix.com