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• The only glucose meters cleared by US FDA and Health Canada for use with all patients, including critically ill

   

  Because of the unacceptably high rate of adverse patient events, including deaths, linked to the point-of-care (POC) use of glucose meters within hospitals, there is a recognized need for more accuracy and better performance standards for POC glucose testing in hospitals, particularly in intensive care settings.

  StatStrip is designed specifically to measure and correct for clinical interferences that can be present in critically ill patients.
  
  Proven safety and accuracy

  • In one study of over 17,300 capillary results from critically ill patients that were compared to lab results
  • In another study of 1,698 arterial and venous results from critically ill patients with over 257 medical conditions were compared to lab results
  • Improved accuracy results in less insulin misdosing and better outcomes for critically ill patients

  Use of any other meter with critically ill patients is considered off label in the U.S. by the FDA and high complexity testing under CLIA

  Use of any other glucose meter with critically ill patients is off label
  StatStrip is FDA and Health Canada cleared and CLIA waived for use throughout all hospital and all professional healthcare settings including critical care. Use of any other glucose meter with critically ill patients is considered off-label in the U.S. by the FDA and high complexity testing under CLIA.

  The personnel testing requirements for off-label use are very demanding and limit who can perform testing. In addition, a hospital must obtain patient consent to perform off-label testing.

   

  The most extensively studied and proven glucose measurement technology
  In addition to the studies submitted to the FDA, 168 other independent studies over the last eight years—including 53 critical care studies—have found no clinically significant interferences for StatStrip. This is a statement that no other glucose meter manufacturer can make. Download a bibliography of publications here

  For more information click here

   

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  StatStrip®和StatStrip Xpress®2血糖儀
• Not yet available in the U.S.

   

  The most extensively studied and proven glucose measurement technology

   

  In addition to studies submitted to the FDA, 168 other independent studies over the last eight years—including 53 critical care studies—have found no clinically significant interferences for StatStrip's measurement technology. This is a statement that no other glucose meter manufacturer can make. StatStrip and StatStrip Xpress2 are the world’s most extensively studied and proven glucose test. It has been proven to be safe and effective for use throughout all hospital and professional healthcare settings including critical care.
  
  

  Wireless meter connectivity to LIS/HIS with StatStrip Glucose/Ketone

   

  The StatStrip Glucose/Ketone Hospital Meter System offers bidirectional wireless connectivity to hospital HIS or LIS with complete security to protect patient data.

  • Wireless connectivity can transmit patient results directly from the bedside, alleviating the need to bring the meter to a fixed location for meter docking and data transmission.
  • Wireless connectivity saves time for the caregiver and allows for faster charting of results and clinical decision making to improve patient care.
  • Dual-band wireless connectivity provides complete security and encryption to ensure that patient data remains uncompromised.
  • Nova now offers a full range of StatStrip Glucose/Ketone wireless connectivity capabilities, including wireless meters, wireless carrying cases, and wireless docking stations.
  • All wireless devices use the industry standard POCT1-A2 data format and are compatible with a choice of middleware partners.

  Measures ketones* with same meter

   

  Easy to use
  No meter preparation or calibration coding steps are required. Insert a ketone strip and StatStrip Glucose/Ketone meter automatically recognizes the strip and converts the meter to ketone measuring mode.

   

  Blood ketone testing should be performed whenever glucose exceeds 14 mmol/L (250 mg/dL)
  Diabetes UK, the Canadian Diabetes Association, the European Society for Paediatric Endocrinology, and the American Diabetes Association (ADA) recommend that blood ketone testing be performed whenever glucose exceeds 14 to 17 mmol/L for rapid detection or prevention of diabetic ketoacidosis (DKA).

   

  StatStrip Glucose/Ketone measures blood beta-hydroxybutyrate, the preferred ketone for diagnosing ketoacidosis
  According to the European Society for Paediatric Endocrinology, Diabetes UK, ADA, and others, blood ketone testing methods that quantify beta-hydroxybutyrate, the predominant ketone body in DKA, are recommended over urine ketone testing for diagnosing and monitoring ketoacidosis.

   

  Ketone testing results obtained from capillary samples
  Capillary blood samples are not only preferred over urine samples to detect and monitor DKA,
  they are also easier to obtain and allow for immediate reflex testing of ketones whenever glucose is greater than 14 mmol/L.

   

  Blood ketone monitoring reduces costs and ICU length of stay for DKA patients
  An ICU study evaluated the effectiveness of blood ketone testing versus urine ketone testing for DKA patients. The blood ketone testing group of patients left the ICU 6.5 hours earlier than the urine ketone testing group. This led to savings of 22 hours of nursing time and 375 laboratory investigations, for a total savings of €2,940.¹

  A second study of DKA patients compared a DKA therapy endpoint of pH > 7.3 and blood ketones < 1.0 mmol/L, versus an endpoint of pH > 7.3 and negative urine ketones. The pH/ blood ketone endpoint was reached after 17 hours, whereas the pH/urine ketone endpoint was not reached until 28 hours after starting treatment. The mean lag between the blood ketone and urine ketone groups was 11 hours, ranging from 1 to 36 hours.²

   

  Blood ketone is more accurate than urine ketone testing
  Blood beta-hydroxyburyrate testing indicates the patient’s status at the time of the test, whereas urine may have been in the bladder for several hours. Urine testing can also produce false positive or negative results due to highly colored urine, highly acidic urine, exposure of the urine test strips to air for prolonged periods, drugs such as the ACE inhibitor captopril, or high doses of vitamin C.

  *Ketone testing is not available with StatStrip meters in the U.S. Glucose is available.

   

  Learn more

  In order to help hospitals avoid the risk of glucose meter off-label use, Nova Biomedical’s technical support resources are ready to help you acquire the StatStrip Glucose Hospital Meter System. To learn more about how StatStrip Glucose can bring critical care testing to the bedside, contact your current GPO or call Nova at 800-458-5813.

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  StatStrip®和StatStrip Xpress®2葡萄糖/酮計
• Fingerstick Capillary Blood Testing for Lactate, Hb, and Hct
   

  The StatStrip Lactate and Hemoglobin/Hematocrit Meter system (StatStrip LAC/Hb/Hct) is a handheld, easy-to-use meter system that measures LAC, Hb and Hct at the point-of-care using two disposable biosensors and tiny capillary blood samples for all tests. StatStrip’s lactate biosensor provides lab-like accuracy in just 13 seconds from 0.6 microliters of capillary blood. StatStrip’s Hb/Hct biosensor accurately measures - not calculates - both Hb and Hct in 40 seconds from a 1.6 microliter capillary sample.

   

  • Two pre-calibrated, disposable biosensors: Lactate and Hemoglobin/Hematocrit
  • Capillary fingerstick blood samples as small as 0.6 μL
  • Results as fast as 13 seconds
  • Lab-like accuracy 

   

  Lactate, Hemoglobin, and Hematocrit

  
  Lactate Testing Bedside
  StatStrip LAC/Hb/Hct is a point-of-care (POC) system that enables rapid and timely trending of lactate in hypoperfusion during sepsis (or other conditions of hypoperfusion) for assessment of resuscitation or treatment efforts. Compared to testing with blood gas analyzers which require arterial samples, large samples volumes (up to 95 microliters), and long analysis times (up to 2.5 minutes); StatStrip’s single-use biosensor provides the fastest turnaround time (13 seconds) on the smallest whole blood sample (0.6 μL) with excellent correlation to central laboratory reference methods.

   

  Solves Lactate Pre-Analytical issues
  Lactate is not stable in whole blood samples. Blood lactate levels rise steeply in less than 5
  minutes if samples are transported or kept at room temperature.¹ StatStrip point-of- care
  testing ensures rapid, accurate results by eliminating sample transport preanalytical effects.

   

  

   

  Hemoglobin and Hematocrit Testing Bedside
  StatStrip LAC/Hb/Hct is the only POC system to provide anemia screening and monitoring with measured, not calculated, Hb and Hct tests. This important breakthrough is possible because of new, patented biosensor technologies developed by Nova Biomedical.
  
  Accurate Assessment of Anemia
  Accurate anemia evaluation requires both measured Hct and measured Hb. However, current POC Hb meters only provide a calculated estimate of Hct. Calculated estimates of Hct are inaccurate in many conditions including red cell structural abnormalities, hemolysis, hemoglobinopathies, and other conditions. These conditions necessitate measured Hct because calculated results can negatively impact treatment.

   

  

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  StatStrip®LAC / Hb / Hct
• Features:

   

  • Fastest turnaround – 13 seconds
  • 0.6 μL whole blood sample
  • Excellent correlation to central laboratory reference methods

  The StatStrip Lactate Hospital Meter System is a handheld point-of-care testing system that brings lactate testing directly to the patient’s bedside.

   

  Lactate is currently measured on blood gas analyzers, which creates numerous problems for bedside testing. Blood gas analyzers require anaerobic arterial samples, large sample volumes (100-200 microliters), and long analysis times (up to 2.5 minutes).

   

  In addition, blood gas analyzers are complex to operate, fixed in location, and expensive to purchase and use for serial lactate testing.

   

  StatStrip Lactate provides the fastest turnaround time possible (13 seconds), on the smallest whole blood sample (0.6 microliters), and can be easily operated by medical and nursing staff. StatStrip Lactate is a very low-cost device that makes lactate testing practical and affordable in any size ED, ICU, or medical unit. It is fully connectable to a hospital's IT system through NovaNet.

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  StatStrip®乳酸和StatStrip Xpress®乳酸係統
• Simple Testing Procedure

   

  1. Place biosensor in meter
  2. Lance finger to create blood drop
  3. Apply blood drop to biosensor
  4. Read creatinine results

  Benefits

   

  • Virtually painless, 1.2 µL fingerstick capillary blood sample
  • Creatinine and eGFR results in 30 seconds
  • Cleared for use by point-of-care (POC) personnel

  
  Radiology and cardiac catherization
  Minimize risk of contrast induced nephropathy (CIN) – StatSensor Creatinine provides rapid, real-time renal assessment prior to contrast imaging.
  
  Improve productivity and workflow – StatSensor Creatinine POC testing can prevent costly procedure room cancellations and workflow interruptions when patients arrive for imaging appointments without a current creatinine/eGFR workup.
  
  Improve patient satisfaction – StatSensor Creatinine testing can prevent patient dissatisfaction when renal function must be determined before an imaging procedure and has not yet been tested when the patient arrives for the procedure.
  
  Oncology
  Reduce medication risks – Renal impairment is frequent in cancer patients, who are at high risk of chemotherapy-induced renal toxicity. StatSensor Creatinine 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 treatment. Obtaining a venous blood sample and sending it to a laboratory for creatinine/eGFR testing could delay chemotherapy for several hours. A chemotherapy treatment that might take a couple of hours could turn into a full day and cause patient dissatisfaction. With StatSensor Creatinine, a capillary blood sample can be obtained and renal function can be quickly determined.
  
  ED: Improve patient triage, expedite patient care
  Various triage 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 Creatinine accurately assesses renal function with a simple, 30-second test that can be easily performed in the ED.

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  StatSensor®和StatSensor Xpress™肌酐和eGFR測量儀
• New Technologies Simplify Use and Offer Additional Tests

  Stat Profile Prime Plus is a comprehensive, whole blood critical care analyzer that combines blood gases, electrolytes, metabolites, CO-Oximetry, and 32 calculated results in a simple, compact analyzer. Prime Plus combines maintenance-free, component cartridge technology for sensors and reagents with patented, new, maintenance-free, and non-lysing whole blood CO-Oximetry technology.

  Prime Plus results are produced rapidly, a complete test menu panel in about one minute, and are combined with bidirectional connectivity, a robust data management system, and comprehensive cybersecurity protection.

   

  Nova MicroSensor Card^™ Technology

   

  

   

  Most comprehensive critical care menu 
  PO₂   PCO₂   pH   Hct   tHb   Na   Cl   K   iCa   TCO₂   iMg   Glu   Lac   Urea (BUN)    Creat   SO₂%   O₂Hb   COHb    MetHb    HHb  

  • All Stat Profile Prime Plus biosensors use proven Nova technology in a miniaturized, maintenance-free sensor card format.
  • Nova MicroSensor cards combine all 20 whole blood assays including CO-Oximetry.

   

  Important New Assays

   

  

   

  Urea (BUN), Creatinine and eGFR
  Over 50% of patients admitted to the ICU will develop some stage of acute kidney injury (AKI).¹ Stat Profile Prime Plus is the only blood gas analyzer to provide whole blood urea (BUN) and creatinine (plus eGFR) test options for rapid assessment of kidney function.
  
  Ionized magnesium (iMg)
  Disruptions in the balance of iMg, Na, K, and iCa can cause cardiac arrhythmias, reduced cardiac contraction, and cardiac arrest. Prime Plus is the only blood gas analyzer to provide a comprehensive profile of electrolytes including iMg.

   

  New Disposable CO-Oximetry Technology Eliminates Maintenance

  Prime Plus incorporates a new, patented multi-wavelength optical system that scans a continuous spectrum of optical wavelengths to enable a comprehensive CO-Oximetry panel result without lysing the sample. The optical components in contact with blood are contained in the disposable sensor card.

  • Cleaning and deproteinising are completely eliminated.
  • Lysing and all its required mechanical components are eliminated, as are lysing and deproteinising reagents. This improves reliability and reduces maintenance and costs.

  
  CO-Oximetry test menu
  O₂Hb     COHb     MetHb     HHb      tHb     

   

  Fast Stat Results

  Prime Plus’s exceptional throughput easily handles the high sample workload of a busy critical care setting. Prime Plus delivers a 20-test critical care profile in about one minute. Competitors’ analyzers can require up to four minutes, even with fewer tests reported.

   

  Clot Protection

  Prime Plus’s unique Clot Block^™ sample flow path protects sensor cards from blood clot blockages.

   

  Bidirectional Connectivity Patient Management

  NovaNet bidirectional middleware for all Nova connected devices
  NovaNet ensures timely, accurate capture of Nova analyzer test results for clinicians and managers to retrieve wherever and whenever needed. Also included is comprehensive cybersecurity protection and encryption that provides protection against attempts to access a hospital's network. 

   

  

   

  Automated, True Liquid QC

   

  

   

  Liquid QC provides the only reliable test of analyzer performance
  United States federal government regulations and many international government regulations have eliminated electronic equivalent QC and are requiring true liquid QC.²

   

  Automated QC complies with U.S. CLIA, German RiLiBAK, and other international QC requirements
  QC cartridges contain a 30-day supply of liquid QC material. Controls are run automatically at user-selected intervals. Prime Plus quality controls:

  • Are comprised of a similar matrix to that of patient samples.
  • Are treated in the same manner as patient samples.
  • Follow the exact sample pathway as patient samples, from sample probe to waste container.
  • Challenge all analytical phases of testing.
  • Challenge testing at patient low, normal, and high value ranges.

  Supplemental Quality Monitoring (SQM)

  Prime Plus provides an automated electronic quality monitoring supplement to liquid QC. SQM continuously monitors the status and performance of all analytical components (including sensors, reagents, calibrators, sample integrity, software, and electronics), providing real-time, sample-to-sample assurance of correct performance.
  
  

   

   

   

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  Stat Profile Prime Plus®
• The New Definition of Simplicity for Critical Care Testing

  Measures: pH   PCO₂   PO₂   Na   K   Cl   iCa   Glu   Lac   Hct

   

  Stat Profile Prime combines the revolutionary microelectronics of the consumer world with Nova Biomedical’s innovative MicroSensor Card™ technology for a smaller, faster, more powerful yet simpler and less expensive analyzer.

   

  Maintenance-free cartridge system

  Stat Profile Prime’s unique cartridge system consists of individual cartridges for sensors, calibrators, and liquid quality control (QC).

   

  Maximum analyzer uptime

  Individual cartridges offer a significant benefit in analyzer uptime compared to combined sensor/calibrator cartridge systems.

   

  Cartridge replacement in seconds

  Each cartridge is ready to use and easily replaced in seconds. Cartridge RFID technology automatically captures cartridge installation time, date, lot number, test parameters, and usage. There is significant savings in analyzer uptime when replacing only a calibrator cartridge, which has no warm-up time, compared to a two-to-four-hour wait for combined cartridge systems.

   

  Individual cartridges lower costs

  Individual cartridges offer a low-cost alternative compared to the inflexibility and waste of combined cartridge systems. For example, an analyzer used in a high volume setting will require fewer sensor cartridges than calibrators, but a low volume setting will require the reverse. In both cases, costs are reduced by using Stat Profile Prime’s individual sensor and calibrator cartridges, which have no waste compared to combined cartridge systems.

   

  MicroSensor card technology

  Accuracy
  All Stat Profile Prime tests use proven Nova biosensor technology in a miniaturized, sensor card format.

   

  Constant stat readiness
  MicroSensor cards have flexible configurations:

  • 200 Samples
  • 400 Samples

  MicroSensor cards are automatically calibrated and always ready for immediate analysis.

   

  

   

  Clot protection
  The unique Clot Block™ sample flow path is designed to protect sensor cartridges from blood clot blockages.

   

  Fastest replacement time
  MicroSensor cards can be replaced, warmed, and calibrated in less than half the time of other cartridge systems, which take more than an hour to calibrate and can remain unstable with drift, frequent re-calibrations, and reduced throughput for even longer periods of time.

   

  Automated, true liquid QC

   

  True liquid QC provides the only reliable test of an analyzer

  
  

   

  In the U.S., federal government regulations (CLIA) are phasing out electronic QC and are requiring true, liquid-based QC. Stat Profile Prime combines both automated, true liquid QC and continuous electronic self-monitoring to ensure lab accuracy and uncompromised quality.

   

  Tri-level QC cartridges automate daily QC
  QC cartridges contain a 30-day supply of liquid QC material. Controls are run automatically at user-selected intervals. An optional QC lockout feature disables any analyte that is not within QC limits.

   

  CLIA QC compliant out of the box
  Stat Profile Prime’s automated QC system complies with all new CLIA requirements.¹ Liquid quality controls follow the identical sample pathway as the blood sample and confirm the entire analytical process for each analyte at multiple levels of concentration. QC statistics are automatically maintained.

   

  Complete automation
  Running QC manually is one of the most time consuming aspects of critical care testing. Stat Profile Prime’s automated, true liquid QC saves hours of time each week, eliminating the need to develop, implement, and document a lengthy, risk-based quality assessment and individualized QC plan.

   

  Supplemental quality monitoring

  Stat Profile Prime provides a supplement to liquid QC by continuously monitoring the status and performance of all analytical components (including sensors, reagents, calibrations, sample integrity, software, and electronics) providing real-time, sample-to-sample assurance of correct performance.

   

  10 critical care tests – results in 60 seconds

  • pH   PCO₂   PO₂   Na   K   Cl   iCa   Glu   Lac   Hct
  • Fast throughput: Up to 45 samples/hour
  • Arterial, venous, or capillary micro-samples: 100 microliters for full menu

   

  Bidirectional connectivity

  Stat Profile Prime's bidirectional software uploads patient and QC results to hospital and laboratory information systems using ASTM or POCT1-A2 formats. The bidirectional interface also enables downloading of test orders, patient identifiers, and patient demographics from the LIS or HIS to Stat Profile Prime. Complete, accurate test records are seamlessly captured for the medical record. Also included is comprehensive cybersecurity protection and encryption that protects PHI and provides an added level of protection against for attempts to access a hospital's network. 

   

  Safe, simple, fast operation

   

  

  Syringes can be docked and sampled with
  hands-free operation.

   

  

  Hands-free capillary sampling can be performed
  without adapters.

   

  

  Samples can be aspirated directly from tubes,
  eliminating sample transfer to a syringe or capillary.

   

  

  QC proficiency ampules can be sampled without adapters.
   
   

  Easy sampling from syringes, capillaries, tubes, and ampoules
  A unique safety sample port protects the user from accidental contact with the sample probe and is easily accessed for all sample containers.

   

  Easy-to-use, high-definition, color touchscreen
  The touchscreen is easily operated through the use of simple and intuitive prompts and requires minimal training.

   

  Three simple steps to initiate a full 10-test profile
  

  1. Press “Start”
  2. Scan or enter patient ID
  3. Press “Aspirate”

   

  Integrated barcode scanner

  The 1D/2D barcode scanner, conveniently located within the sample port allows for fast, error-free entry of operator and patient IDs. The optional, wireless, external barcode scanner also allows for positive patient ID, further eliminating pre-analytical error.

   

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  statprofile Prime®CCS分析儀
• *Not yet available in all markets