Whole Blood Glucose Reference Analyzer

Nova Primary addresses the needs of glucose device manufacturers and clinical diabetes researchers for an accurate, easy-to-use, modern blood glucose reference analyzer to replace the discontinued YSI STAT PLUS 2300 (YSI, Inc., Yellow Springs, OH). The Nova Primary glucose reference analyzer answers this need with state-of-the art features including:
• Accurate biosensor measuring technology
• 25 μL whole blood sample
• Automatic hematocrit measurement and correction for plasma equivalent glucose results
• Simple, color touchscreen operation
• On-board data storage and export

Accurate Biosensor Technology
Nova Primary measures glucose in whole blood and plasma with a glucose oxidase electrochemistry sensor, the same accurate, reliable technology proven in Nova’s Stat Profile critical care analyzers for over 20 years. Glucose in the sample is rapidly oxidized by the biosensor’s glucose oxidase membrane cap, producing hydrogen peroxide. The hydrogen peroxide is oxidized at the electrode base (platinum anode), producing a current directly proportional to the concentration of glucose in the sample. Snap-in, glucose oxidase membrane caps are easily replaced in seconds and have a use-life of up to 3 weeks. The electrode base has a use-life of up to one year.

Excellent Correlation to the YSI 2300
The Nova Primary provides excellent correlation of whole blood and plasma samples to the YSI 2300 across a wide measurement range of 20-750 mg/dL. Calibrators and controls are traceable to National Institute of Standards and Technology (NIST) Standard SRM-917, assuring excellent lot-to-lot consistency and glucose testing accuracy.

Touchscreen operation
Using a large (10.1”) modern color touchscreen interface, Nova Primary can be operated with minimal training. Performing a whole blood glucose test requires only 3 steps, versus 8 steps for the YSI 2300

Nova Primary sample analysis
1. Press "Analyze"
2. Position Sample
3. Press "Aspirate"

YSI 2300 sample analysis
1. Measure Hematocrit
2. Press “Run”
3. Press “Sample”
4. Enter Hct digit 1
5. Enter Hct digit 2
6. Press “Enter”
07. Position “Sample”
8. Press “Sample”

 

Comprehensive data storage and export
Nova Primary has on-board storage for thousands of test results and QC samples. Test data is exported through the USB port using comma delimited (csv) format for easy data capture, review, analysis, and sorting. Data can also be connected to laboratory information systems with Nova Prime's ASTM, HL7, or POCT1-A2 communication protocols.

 

Automates the analysis of plasma equivalent whole blood glucose
Nova Primary automatically measures the hematocrit levels of whole blood samples and uses them to calculate an accurate plasma equivalent whole blood glucose. This eliminates the need for a separate hematocrit assay and manual entry of hematocrit values for each glucose sample.

Single calibrator cartridge simplifies reagent maintenance
Nova Primary uses a single, plug-in, reagent cartridge instead of separate calibrator, buffer, and waste bottles. The cartridge contains ready-to-use, pre-made calibrators, plus a built-in waste receptacle for easy maintenance. Cartridge replacement takes less than 2 minutes.
Other cartridge benefits:
• Multiple cartridge capacities accommodate variable sample workloads
• RFID technology reports the cartridge expiration date and number of samples remaining
• Eliminates the need for daily checking of individual calibration, buffer, waste bottle levels, and separate replacement schedules
• Eliminates weekly or daily manual preparation of buffer solutions
• Eliminates maintenance to the waste receptacle, a potential biohazard

Eliminates peristaltic pump maintenance
The YSI 2300 used two peristaltic pumps and a magnetic mixer to perform sample and calibrator dilutions and mixing. Peristaltic pump tubing can degrade with time and becomes loose at the fitting, affecting dilution accuracy and requiring replacement. Nova Primary uses a highly accurate, maintenance-free syringe pump to perform sample dilutions and mixing.
Syringe Pump benefits:
• Eliminates the need for periodic replacement of sample and calibrator peristaltic pump tubing
• Eliminates monthly cleaning of calibrant pumping system
• Provides consistently accurate sample dilution and mixing

Cybersecurity Protection
Nova Primary has extensive safeguards to protect the system from outside cybersecurity attacks. The main operating system is an embedded, light version of Windows® with Windows Defender anti-virus firewall.

 

Nova Primary Specifications
Glucose Measurement Range: 20 - 750 mg/dL
Acceptable Samples: Whole blood (heparinized) and plasma/serum
Sample Volume: 25 μL
Glucose Measurement Time: Single analysis: 1.5 minutes, Throughput: 35 samples per hour
Operating Temperature Range: 15°C - 32°C (59°F - 89.6°F)
Electrical Power Requirement: 180 Watts2 connectivity formats.
Physical Specifications: 26.5 lb (12.0 kg) without reagent pack; 31.9 lb (14.5 kg) with full reagent pack, power supply and wireless keyboard. It can be operated benchtop or on a mobile cart with battery backup.
Printer: On-board Thermal Printer
Certifications: Universal: EN ISO 13485:2016 EU: EN 61010-1:2010/AMD1:2019; EN 61010-2-101:2017; EN 61326-2-6:2013; EN 55011:2016 US: IEC 61010-1:2010/AMD1:2016; IEC 61010-2-101:2018; IEC 60601-1-2:2014
Calibration: Fully automatic two-point calibration; Manual calibration initiated at any time.
Communication Protocols: ASTM, HL7, or POCT1-A