FDA has cleared the Stat Profile Prime Plus critical care blood gas analyzer from Nova Biomedical, Waltham, Mass, for point-of-care use. The agency’s clearance will allow healthcare personnel to perform bedside critical care testing, with lab-quality results in as little as 1 minute.
The Stat Profile Prime Plus analyzer employs maintenance-free sensor technology to provide 19 critical care tests, including blood gases, cooximetry, electrolytes, hematology, and metabolites. The unit enables clinicians to compile a rapid, detailed diagnostic profile, including a comprehensive metabolic panel.
The analyzer incorporates Nova’s maintenance-free sensor technology with individual microsensor cards, calibrator cartridges, and quality control cartridges. This design eliminates sensor and cooximeter maintenance, improves analyzer uptime, and reduces testing costs.
The analyzer’s microsensor card requires a minimum sample volume of 60 μL, and provides a critical care panel that includes Cl, COHb, creatinine, glucose, Hb, Hct, HHb iCa, iMg, K, lactate, MetHb, Na, O2Hb, PCO2, pH, PO2, SO2%, and urea. The unit features patented, nonlysing whole blood cooximetry technology, which eliminates corrosive lysing reagents and mechanical complexity while improving instrument reliability and reducing costs.
A unique safety sample port allows for easy docking and hands-free sampling, and the unit’s clot block sample flow path protects sensors from blood clot blockages and related downtime.
Stat Profile Prime Plus provides real-time supplemental quality monitoring with automated quality control that verifies analyzer accuracy and precision. The unit’s onboard assayed liquid controls meet or exceed all current regulatory guidelines and do not require the development of an individualized quality control plan. Supplemental quality monitoring electronically tracks and verifies analytical performance between quality control intervals and for each analysis and calibration.
For more information, visit Nova Biomedical.