Nova Hospital Crea Measuring System

Single-Use Creatinine Biosensor Test Strip

Virtually Painless Finger Stick Capillary Blood Sample,1.2 μL

Fast, 30 Second Analysis

Wide Measurement Range 27-1050 μmol/L (0.3-12 mg/dL)

Calculated eGFR and Creatinine Clearance

Nova StatSensor Creatinine Measuring System

In response to the growing need to quickly and easily assess kidney function in many point-of-care settings, Nova Biomedical introduces StatSensor Creatinine, a handheld analyzer and miniaturized, disposable biosensor for whole blood creatinine testing. StatSensor Creatinine system incorporates new, patented Multi-Well™ technology adapted from Nova’s hospital glucose monitoring system. StatSensor advanced technology now enables simple, rapid, and accurate assessment of renal function by finger stick capillary blood sampling at the point of care.

It features:

• Creatinine accuracy comparable to hospital laboratory testing
• Estimated glomerular fi ltration rate (eGFR) by MDRD and Cockcroft-Gault equations
• Simple test procedure (single use, precalibrated disposables)
• Virtually painless, fi ngerstick capillary blood sampling (1.2 μL)
• Fast, 30 second results
• Wide measurement range: 27 μmol/L to 1050 μmol/L (0.3-12 mg/dL)

Creatinine with eGFR Enhances Assessment of Renal Function

The whole blood creatinine concentration has limitations when used alone to assess kidney function. While creatinine is the best single blood test for kidney function, it is infl uenced by age, gender, race, and body composition. For example, an elderly person could lose half of his/her kidney function before creatinine rises above the upper limit of normal. Conversely, eGFR may decline by approximately 50% of normal level before the creatinine concentration rises above the upper limit of normal.

Creatinine with eGFR is a more accurate and sensitive assessment of kidney function than creatinine alone. eGFR takes into account the creatinine concentration and other variables including: age, gender, race, and body size.

StatSensor calculates glomerular fi ltration rate (eGFR) by MDRD and Creatinine Clearance (CrCl) by Cockcroft-Gault equations.

Another Technology Advance From Nova Biomedical, the World Leader In Whole Blood Testing

Nova Biomedical is the world technology leader in the development of advanced biosensors for whole blood analysis. During the past 30 years, Nova has introduced 20 biosensors, including the industry’s first biosensor to directly measure whole blood glucose in 1988, and the industry’s fi rst biosensor to directly measure whole blood creatinine in 1996. These earlier biosensors are used routinely in thousands of hospital laboratories and critical care settings around the world in our Stat Profi le® brand blood gas/critical care analyzers. Now Nova has incorporated its creatinine biosensor technology into a precalibrated, single use, disposable system that provides laboratory quality test results at the point of care.

Rapid, Easy to Use, Point-of-Care Creatinine Testing

No User Calibration

StatSensor biosensors are precalibrated immediately and ready to use.

• No analyzer or biosensor preanalytical steps, such as using a calibrating reagent or entering a calibration code in the analyzer, are necessary.
• By eliminating this calibration step, StatSensor is actually simpler to operate than most meters used by diabetics at home to self-test for glucose.

Simple Test Procedure

A bright, easy to read, color screen prompts the user through the StatSensor test procedure.

1. Place the sensor in meter
2. Stick fi nger to create blood drop
3. Apply strip to blood drop
4. Read creatinine results

Fast, 30 Second Creatinine Results

Assessment of kidney function can be made in real time at the point of care. Patient care treatments that require prior kidney assessment can be expedited.

Creatinine with eGFR Enhances Renal Function Assessment

StatSensor can calculate eGFR by two different equations. eGFR and creatinine results are displayed along with normal ranges. Abnormal results are prominently flagged with color highlighting, text, and symbols.

Cleared for Use by Point-of-Care Personnel

StatSensor can be used by nurses, radiology technicians, or other non-laboratory personnel.

Capillary Blood Sampling is Virtually Painless

StatSensor uses a very small, 1.2 microliter blood sample (less than one drop). Samples can be obtained virtually painlessly from a capillary fi nger stick using the same type lancet used by diabetics at home to self-test for glucose. No venous blood drawing or phlebotomist is needed.

StatSensor Accuracy is Comparable to Hospital Laboratory Testing

Point-of-care testing is often performed on a hospital’s most critical patients. The test results may be used to make immediate decisions
regarding patient care. Point-of-care testing demands a level of analytical performance as accurate and precise as testing performed in the hospital laboratory. Advanced StatSensor technology provides that performance.

StatSensor Measures and Eliminates Interference Due to Hematocrit

Measurements made on whole blood samples are subject to interference due to varying hematocrit levels of the sample. One of the three StatSensor measurement wells measures and corrects for varying hematocrit levels. Accurate results are obtained throughout a broad range of hematocrit.

Interfaces with Hospital and Laboratory Information Systems

NovaNet Desktop software combined with multiple choices of interface and data management software systems provide comprehensive connectivity, management, and control for StatSensor point-of-care testing. These systems provide the critical components for successful point-of-care testing including:

• LIS/HIS Interface and Connectivity Management
• Management of Patient and QC Data
• Regulatory Compliance via Audit Logs, Reports, and Records

Product Website: Nova Biomedical Product Page