StatStrip Glucose Monitoring System
For point of care
The Nova StatStrip™ point-of-care glucose monitor from Nova Biomedical, Waltham, Mass, incorporates a patented new strip technology that uses four measuring wells. Nova’s Multi-Well™ system measures and corrects hematocrit interference and interferences from acetaminophen (Tylenol), uric acid, ascorbic acid (Vitamin C), maltose, galactose, xylose, and lactose. The system helps eliminate oxygen interference to provide glucose results regardless of the sample’s oxygen status. A 6-second analysis time, 1.2-microliter sample size, and color touch-screen operation aid in bedside glucose testing for point-of-care staff. It requires no calibration codes, eliminating an operator step and helping to prevent a potential input error. Instrument Manager software provides management, control, and regulatory compliance, and allows the system to be customized to the needs of each department within the hospital.
Nova Biomedical
(800) 458-5813
www.novabiomedical.com
Cystatin C Assay
Quantitative determination in serum and plasma
Diazyme Laboratories, Poway, Calif, has received 510(k) clearance for its new Cystatin C assay kit for the quantitative determination of Cystatin C in serum and plasma samples. The liquid stable, two-reagent immunoturbidimetric system can be applied to most common clinical chemistry instrumentation. The assay offers an extended reportable range of 0.47 to more than 8 mg/L, which helps reduce the need for retesting elevated patient samples. The method demonstrates insignificant bias from interferents commonly found in serum, such as highly elevated levels of hemoglobin, bilirubin, triglycerides, and ascorbic acid. The company has developed a listing of instrument parameters and, along with multiple packaging formats, offers instrument-specific formats suitable for use in labs with varied volumes and workflows.
Diazyme Laboratories
(858) 455-4768
www.diazyme.com
RapidPoint 400 Blood Gas Series
Assesses oxygenation status
Rapidpoint® 400/405 blood gas analyzers from Siemens Healthcare Diagnostics, Deerfield, Ill, offer no maintenance, intuitive sample management, and onboard quality control management. The systems report pH/blood gas, electrolytes, glucose, hematocrit, and full CO-oximetry results within 60 seconds, and offer an integrated CO-oximetry module for point-of-care testing. They provide a comprehensive assessment of the oxygenation status of critically ill patients.
Siemens Healthcare Diagnostics
(800) 431-1970
www.siemens.com/diagnostics
Direct HbA1c Reagent
Single-channel immunoturbidimetric assay
The new Direct HbA1c reagent for general chemistry analyzers from Pointe Scientific Inc, Canton, Mich, is a single-channel immunoturbidimetric assay that employs nonspecific binding in the first reaction and specific antibodies in the second reaction, resulting in agglutination of only HbA1c-bound latex particles. The absorbance of the agglutination is measured at 600 nm to 660 nm, and the %HbA1c concentration is determined using calibrators with known %HbA1c values. The reagent shows minimal sensitivity loss of the combined R2 reagent on board a chemistry analyzer, which may result in less frequent calibrations—particularly in smaller-volume labs that do not use reagent as quickly as high-volume labs. The increase in calibration stability for these users may result in more cost-effective determinations of HbA1c. There is no change in precision or method comparison versus HPLC. NGSP certification is valid for the improved reagent. All instrument applications remain unchanged, and there is no need for a separate total hemoglobin measurement and additional calculations. The assay is fully automated for analyzers capable of sample predilution.
Pointe Scientific Inc
(800) 757-5156
www.pointescientific.com
DCA Vantage Analyzer
For diabetes management
Siemens Healthcare Diagnostics, Deerfield, Ill, introduces the new DCA Vantage™ analyzer, a point-of-care diabetes patient-management platform providing glycosylated hemoglobin (HbA1c), microalbumin/creatinine, and albumin-to-creatinine tests for diabetes management. It is helpful for monitoring a patient’s glycemic control and for physicians who encourage patient compliance by delivering actionable test results during a patient visit. It needs no sample or reagent preparation steps, and is CLIA waived and NGSP certified for HbA1c tests. Physicians enter a patient ID via touch screen or bar code, view the onboard printed reports and HbA1c patient-trending graphs, and download patient results to an external hospital information system. Features such as connectivity to LIS, operator ID entry, QC reminders, test lockout, remote access, and adjustable correlation to reference methods are available for testing sites that require compliance and control of decentralized testing. Users can adjust correlation parameters to match reference assays or standardize results over multiple systems.
Siemens Healthcare Diagnostics
(800) 431-1970
www.siemens.com/diagnostics
QC A1C
Assayed quality control
The QC A1C Control offered by RNA Medical, Devens, Mass, is an assayed quality control material used for monitoring the performance of Bayer® DCA 2000® and 2000+® analyzers that measure Hb A1c. The dye-based aqueous solution is liquid-ready, does not require reconstitution prior to use, and is provided in dropper bottles that contain 1.0 mL of solution. It is available in two levels (normal and abnormal) for monitoring analyzer performance at varying points within the clinical range. Bottles are packaged in boxes that contain two bottles of normal control and two bottles of abnormal control. The product has a shelf life of 18 months when stored refrigerated (2-8°C). After opening, each bottle of control is stable for 90 days if stored refrigerated, or 30 days if stored at room temperature (up to 25°C).
RNA Medical
(800) 533-6162
www.RNAMedical.com
