StatSensor® Creatinine
StatSensor® XpressTM Creatinine

StatSensor Xpress not available in the U.S.

Nova StatSensor® Point-of-Care Creatinine and eGFR Measuring System

StatSensor Creatinine is a handheld analyzer and miniaturized, disposable biosensor for whole blood creatinine testing. StatSensor incorporates a patented Multi-Well technology adapted from Nova’s hospital glucose monitoring system. StatSensor advanced technology enables simple rapid and accurate assessment of renal function by finger stick capillary blood sampling at the point of care.

Simple Test Procedure

  • Place the biosensor in meter
  • Stick finger to create blood drop
  • Apply blood drop to strip
  • Read creatinine results.

Virtually Painless, Finger Stick Capillary Blood Sample, 1.2 ul

Fast, 30 Second Creatinine and eGFR Results

Cleared for Use by Point of Care Personnel

 

StatSensor® Benefits

For Radiology and Cardiac Catherization

  • Minimize Risk of Contrast Media Induced Nephropathy (CMIN) - StatSensor provides rapid, point of care renal assessment prior to contrast media imaging
  • Improve Productivity and Workflow - StatSensor point of care testing can prevent costly procedure room openings and workflow interruptions when patients arrive for imaging appointments without a current creatinine/eGFR workup.
  • Improve Patient Satisfaction - StatSensor point of care testing can prevent patient dissatisfaction when renal function must be determined before an image procedure can be performed.

For Oncology

  • Reduce Medication Risks - Renal impairment is frequent in cancer patients and these patients are at high risk of chemotherapy-induced renal toxicity. StatSensor provides important kidney function information for chemotherapy drug selection and dosing.
  • Improve Patient Satisfaction - Many cancer outpatients need to have their kidney function assessed before receiving their chemotherapy session. Obtaining a venous blood sample and sending it to a laboratory for creatinine eGFR testing could delay chemotherapy for several hours. A chemotherapy session that might take a couple of hours could turn into a full day and cause patient dissatisfaction with their session. With StatSensor, a capillary blood sample can be obtained and renal function can be quickly determined.

For ED: Improve Patient Triage, Expedite Patient Care

Various patient care protocols in the emergency department may require rapid assessment of renal function in order to triage the patient. In addition, many ED therapies require timely administration of drugs and adjustment of drug dosage based on renal function. StatSensor accurately assess renal function with a simple 30 second test that can be easily performed in the ED.

StatSensor® Specifications


Tests:

Tests Measured: Creatinine
Test Reported: Creatinine and eGFR
Test Time: 30 seconds
Test Strip Volume: 1.2 µL
Test Methodology: Electrochemistry
Weight: 0.8 lbs (360 g)
Size: 6.0 in x 3.25 in x 1.8 in (153 mm x 82.5 mm x 46 mm)

Selectable eGFR Calculation Equations:

Abbreviated MDRD and Cockroft-Gault

Sample Types & Operating Modes:

Whole Blood: Arterial, Venous, Capillary

Measurement Range:

Creatinine 0.3-12.0 mg/dl (27-1056 µmol/L)

Operating Ranges:

Temperature: 15°C- 40°C (59°F-104°F)
Altitude: Up to 15,000 feet
Humidity: 10% to 90% relative humidity

Reagents and Strips:

Strips: 25 strips per vial
QC: Three levels (Low, Normal, High);
sold separately
Linearity: Five levels available

Test Strip & QC Stability:

12 months (4-8°c)
3 months open-vial stability

Data Storage:

Patient Tests: 1,000 tests
QC Tests: 200 tests
Users: 4,000 users

Connectivity:

Data Output Port: Etherent (10 Mbit)
Meter Data Output: RJ-45 Ethernet Port
Protocol: TCP/IP Ethernet 10 Mbit
Standard: POCT1-A Compliant
Setup Program: NovaNet™ Web-Based Instrument Manager Software

Battery Information:

Type: 3.7V Li Polymer Rechargeable Battery
Features: Rechargeable/Replaceable
Life: 8 hours in use (approximately 40 tests
w/barcode scans) / 12-24 hours standby

Docking Station:

Optional accessory; desk or wall mount charging station with RJ-45 Ethernet jack. 3 LED indicator lights showing connection status, transmit/receive data, and charging status.
Extra battery slot included for recharging and storage of spare battery.

Additional Features:

  • Color touch screen
  • Built-in barcode scanner
  • Traditional QC with target values assigned to QC materials
  • Numeric or pass/fail QC
  • QC prompting or QC lock out
  • Abnormal and critical ranges flagged by color highlighting
  • Canned or free text user comments
  • Rejecting of results at meter (optional) for repeat testing
  • Accepting patient ID or accession number
  • Use of operator password (lockout)
  • Entry of ICD-9 Diagnosis codes
  • Ordering physicians I.D.
  • Slope and intercept adjustment
  • Web-based meter configuration by location
  • Custom meter configuration by medical unit
  • Connect to hospital ADT
  • Connect to all LIS/EMR
  • POCT1-A data output
  • Optional Carrying Case
 

StatSensor® Creatinine Xpress Meter


Weight: 0.2 lbs (75 g)
Size: 3.6 in x 2.3 in x 0.9 in (91 mm x 58 mm x 23 mm)

Data Storage:

Patient & QC Tests: 400 tests total (FIFO)

Connectivity:

Data Transfer: Strip Port Connection to USB
Data Program: Nova Microsoft-Excel based data transfer Software

Battery Information:

Type: 3V Li Button Battery
Features: Replaceable
Life: Minimum 600 tests

Additional Features:

  • LCD black/white display
  • Large numeric display (30 mm)
  • Traditional QC with target values assigned to QC materials
  • Units of measure based on meter ordered (mg/dl or µmol/L models)
  • Auto-shut off of meter when not in use
  • Automatic sample detection and analysis start
  • Automatic sample counter with date/time stamp for data tracking
 

Certifications & Compliance: ISO 13485:2003 Quality System Registration, IVDD, Meets IEC 61010, UL, CSA Standards
FDA Labeling: For in-vitro diagnostic use.
Patented Technology. Patents 6,287,451 / 6,837,976 / EP 1 212 609 / CA 2,375,092 / EP 1497 449 / JP 405 0078
Specifications subject to change without notice.