Hospital Glucose Monitoring System

Hospital Glucose Monitoring System
No. 260 StatStrip Glucose Rev. 1/19/2012 Hospital Glucose Monitoring System Hospital Glucose Meter Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

Nova is the World Leader in Whole Blood Biosensors
No. 260 StatStrip Glucose Rev. 1/19/2012 Nova BioSensor Firsts 1978 First biosensor for Ionized Calcium 1980 First biosensor to measure Chloride in blood 1984 First biosensor to measure Total Calcium 1985 First biosensor to measure Hematocrit by ISE/Conductivity 1987 First biosensor to directly measure whole blood Glucose 1988 First biosensor to measure Lithium 1990 First biosensor to measure BUN (urea) 1992 First biosensor to directly measure whole blood Lactate 1994 First biosensor to measure Ionized Magnesium 1996 First biosensor to measure Creatinine 1996 First biosensor to measure Total CO2 in whole blood 1997 First multi-wavelength fiber optic SO2% assay 1998 First fiber optic Hemoglobin assay 1998 First Ammonium biosensor 1999 First non-diluting direct Glutamine biosensor 1999 First non-diluting direct Glutamate biosensor 2001 First Acetate biosensor 2005 First Hematocrit corrected Glucose strip 2007 First calibration free Glucose strip 2007 First Creatinine strip and meter 2009 First calibration free Ketone strip 2009 First IgG assay on a biotechnology analyzer 2011 First Hematocrit corrected hospital Lactate meter and strip Nova has a rich history of pioneering the development of dozens of assays and biosensor measurement technologies. When presenting for a group interested in glucose, highlight the fact that we developed the first biosensor to directly measure whole blood glucose and that this has been miniaturized into a test strip based biosensor. Remind them that a lot of technology development has gone into the creation of the StatStrip strip. For a creatinine audience, a similar tie can be made to our development of a creatinine sensor in 1996.

Nova Brand Products No. 260 StatStrip Glucose Rev. 1/19/2012
Stat Profile® pHOx Ultra Test Menu: pH, PCO2, PO2, SO2%, Hct, Hb, Na+, K+, Cl-, Ca++, Mg++, TCO2, Glu, BUN, Creat, Lac, HHb, O2Hb, Methb, COHb, O2Ct, O2Cap, tBil Samples: Whole blood, Serum, Plasma Stat Profile® pHOx Test Menu: pH, PCO2, PO2, SO2%, Hct, Hb, Na+, K+, Cl-, Ca++, Glu, Lac Samples: Whole blood, Serum, Plasma Nova Chemistry Analyzers Test Menu: Na+, K+, Cl-, TCO2, Ca++, Mg++, Li+, TCa, Glu, BUN, Crea, Hct, pH Samples: Whole blood, Serum, Plasma Nova BioProfile FLEX™ Test Menu: Gluc, Lac, Gln, Glu, NH4+, pH, PO2, PCO2, Na+, K+, Ca++, CD, CV, Osm, IgG, PO4 Samples: Cell Culture Media * Nova’s products range from desktop whole blood analyzers that can measure up to 20 different analytes, to hand-held, test strip based point of care hospital meters for specialized analyte testing, and consumer self-test blood glucose meters. We also provide analyzers for the biotech industry that simplify process control. Nova StatStrip® Test Menu: Glucose Samples: Whole blood Nova StatStrip® Test Menu: Glucose/Ketone Samples: Whole blood Nova StatStrip® Test Menu: Lactate Samples: Whole blood Nova StatSensor® Test Menu: Creatinine Samples: Whole blood Nova MAX® Plus Test Menu: Glucose/Ketone Samples: Whole blood Nova MAX® Link ® Test Menu: Glucose Samples: Whole blood Nova Lactate Plus ® Test Menu: Lactate Samples: Whole blood * Currently Available outside the U.S.

Hospital Laboratory Instrument Platform
No. 260 StatStrip Glucose Rev. 1/19/2012

Hospital Laboratory Platform

Hospital Point-of-Care Glucose Meter

Hospital Point-of-Care Lactate Meter

Hospital Point-of-Care Creatinine Meter

Home Glucose Wireless Monitor
No. 260 StatStrip Glucose Rev. 1/19/2012 Nova Max® Plus Home Glucose Monitor Nova Max Link® Home Glucose Wireless Monitor

Professional Lactate Meter

Nova Handheld Point-of-Care Hospital Analyzers
No. 260 StatStrip Glucose Rev. 1/19/2012 Nova Handheld Point-of-Care Hospital Analyzers *

Nova Multi-Well Technology Creates A New Level of Analytical Performance
No. 260 StatStrip Glucose Rev. 1/19/2012 TM Hospital Glucose Meter Hospital Glucose Meter

Laboratory quality accuracy and precision from 10 to 600 mg/dL
No. 260 StatStrip Glucose Rev. 1/19/2012 Hospital Glucose Meter The World’s Most Accurate Hospital Glucose Meter Proven in Over 60 Published Hospital Evaluations Worldwide Laboratory quality accuracy and precision from 10 to 600 mg/dL Measures and corrects interferences from: - Hematocrit - Electrochemical interferences including acetaminophen, ascorbic acid, and uric acid No maltose, galactose, xylose or oxygen interference Eliminates calibration codes Fastest results, 6 seconds Small sample, 1.2 µL whole blood Nova Connects™, Total POC Connectivity Solution StatStrip is the first meter and strip designed for the current, more demanding requirements of bedside glucose testing. These demands include the need for lab-like analytical performance, freedom from common interferences such as hematocrit and drugs, and elimination of operator technique and operator errors. StatStrip incorporates a patented, multi well technology that creates a new level of analytical performance for bedside glucose testing. StatStrip is the only meter and strip to actually measure and eliminate interferences from hematocrit and all electrochemical substances, including acetaminophen, ascorbic acid and uric acid. In addition StatStrip has no interference from maltose, galactose, xylose or oxygen. Over 50 peer-reviewed clinical studies have validated StatStrip lab-like analytical performance across a wide glucose range of 10 to 600 g/dL StatStrip also eliminates calibration codes required of all other hospital meters. This eliminates an operator step and a source of operator error StatStrip lab-like analytical performance is coupled with the fastest analysis time, the smallest sample size of any hospital meter, plus many other excusive features for bedside glucose testing. StatStrip® Hospital Connectivity Meter

StatStrip® Has Earned Worldwide Scientific Acclaim
No. 260 StatStrip Glucose Rev. 1/19/2012 StatStrip® Has Earned Worldwide Scientific Acclaim The overwhelming volume of scientific papers, with experts all in agreement, validate StatStrip’s improved accuracy over competitive glucose monitors. These are just a few of the quotes taken from those papers that attest to StatStrip’s accuracy.

StatStrip® Multi-Well Technology Correlation Study
No. 260 StatStrip Glucose Rev. 1/19/2012 StatStrip® Multi-Well Technology Correlation Study TM R2: SLOPE: 1.018 INTERCEPT: mmol/L INTERCEPT: mg/dL N=1703 Sy*x = 0.54 mmol/L Sy*x = mg/dL (mmol/L) 700 600 400 300 200 100 500 33.3 5.6 11.1 16.7 22.2 27.8 38.9 (mg/dL) (mmol/L) Nova StatStrip Whole Blood Glucose This correlation graph combines data from 35 evaluations of StatStrip performed by hospitals around the US. The combined data from these sites is compared to the central laboratory hexokinase reference methods employed at each hospital. This study was run using whole blood (StatStrip) versus plasma (Reference). There is an OUTSTANDING agreement between StatStrip and the Reference methods, r2 = with a slope of 1.018, throughout: 1,700 data points 35 different hospital sites 14 different reference models 10 different lots of StatStrip test strips. There is very limited scatter throughout the entire linear range of the data ( mg/dL). In fact the graph shows very limited scatter at very high and low levels of glucose. This is important to note because the correlations of the competitive analyzers show significant scatter as low as 150 mg/dL It is important to consider the tight correlation as it relates to insulin dosing/patient safety issues. Sy*x is a calculation of scatter. The lower the number the better. This calculation quantifies the scatter or standard deviation around a “best fit correlation line” This data is evidence of the exceptional lot-to-lot, hospital-to-hospital, lab-like performance of StatStrip (mg/dL) Plasma Glucose Reference Method Kost, G. et al AACC, July 07; Diabetes Technology, Oct 07 16

Abbott PCx Correlation Study
No. 260 StatStrip Glucose Rev. 1/19/2012 Abbott PCx Correlation Study R2: SLOPE: 0.89 INTERCEPT: 0.00 mmol/L INTERCEPT: mg/dL N=559 Sy*x = 1.84 mmol/L Sy*x = mg/dL (mmol/L) 5.6 11.1 16.7 22.2 27.8 33.3 700 38.9 600 33.3 500 27.8 400 22.2 (mg/dL) (mmol/L) Abbott PCx Whole Blood Glucose 300 16.7 200 11.1 100 5.6 This is the Abbott PCx data from a subset of the 35 hospital evaluations. (The Abbott PCx was not involved in all 35 hospital evaluations. ) The were 559 data points for this meter. The correlation (r2) of the Abbott PCx to the lab reference and slope for Abbott (r2 = , slope =1.123) is significantly worse than the StatStrip (r2 = 0.995, slope =1.018). Significant data scatter with this method starts at about 120 mg/dL but is significantly troubling at ~160 mg/dL. This scatter can lead to glucose errors versus the central lab and insulin dosing errors. The Sy*x of here is significantly higher than that of StatStrip. 100 200 300 400 500 600 (mg/dL) Plasma Glucose Reference Method Kost, G. et al AACC, July 07; Diabetes Technology, Oct 07

Abbott PXP Correlation Study
No. 260 StatStrip Glucose Rev. 1/19/2012 Abbott PXP Correlation Study R2: SLOPE: 0.820 INTERCEPT: 1.05 mmol/L INTERCEPT: mg/dL N=225 Sy*x = 1.8 mmol/L Sy*x = mg/dL (mmol/L) 5.6 11.1 16.7 22.2 27.8 33.3 600 33.3 500 27.8 400 22.2 (mg/dL) (mmol/L) 300 16.7 Abbott PXP Whole Blood Glucose 200 11.1 100 5.6 This Abbott PXP data set, for the latest Abbott hospital test strip, tested 225 data points. (Note this data was not part of the Kost data. This data is from Nova lab evaluations) The correlation (r2) of the Abbott PXP to the lab reference and slope for Abbott (r2 = , slope =0.820) is significantly worse than the StatStrip (r2 = 0.995, slope =1.018). The Intercept value of shows that there is a significant offset from true glucose readings at the low glucose levels. A good amount of data scatter is shown with this strip as well beginning at about 120 mg/dL. The Sy*x of here is still significantly higher than that of StatStrip. The PXP data is very similar to the PCx data. Showing this graphs back to back can demonstrate that the “new” strip is not really new and definitely not improved 100 200 300 400 500 600 (mg/dL) Plasma Glucose Reference Method Kost, G. et al AACC, July 07; Diabetes Technology, Oct 07

LifeScan SureStep Correlation Study
No. 260 StatStrip Glucose Rev. 1/19/2012 R2: SLOPE: 1.029 INTERCEPT: mmol/L INTERCEPT: mg/dL N=628 Sy*x = 0.86 mmol/L Sy*x = mg/dL 700 600 400 300 200 100 500 LifeScan Whole Blood Glucose 38.9 (mmol/L) 33.3 5.6 11.1 16.7 22.2 27.8 (mg/dL) This is the Lifescan data from a subset of the 35 hospitals. (The Lifescan meter was not involved in every hospital evaluation). The were 626 data points for this meter. The correlation (r2) of the Lifescan to the lab reference and slope for Lifescan (r2 =0.987, slope =1.123) is significantly worse than StatStrip (r2 = 0.995, slope = 1.018) The data scatter with this method starts at about 300 mg/dL. This scatter can lead to glucose errors versus the central lab and insulin dosing errors. Std Deviation of the Lifescan bias is mg/dL The Std Deviation of StatStrip bias is only mg/dL. Plasma Glucose Reference Method Kost, G. et al AACC, July 07; Diabetes Technology, Oct 07

Roche Accu-Chek Correlation Study
No. 260 StatStrip Glucose Rev. 1/19/2012 Roche Accu-Chek Correlation Study R2: SLOPE: 1.036 INTERCEPT: 0.28 mmol/L INTERCEPT: mg/dL N=273 Sy*x = 1.18 mmol/L Sy*x = mg/dL (mmol/L) 5.6 11.1 16.7 22.2 27.8 33.3 700 38.9 600 33.3 500 27.8 400 22.2 (mg/dL) (mmol/L) Roche Whole Blood Glucose 300 16.7 200 11.1 100 5.6 This is the Roche Accu-Chek Inform data from a subset of the 35 hospital evaluations. (The Roche Inform was not involved in all 35 evaluations). The were 273 data points for this meter. The (r2) correlation of the Roche Inform to the lab reference and slope for Roche (r2 = , slope =1.036) is significantly worse than StatStrip (r2 = 0.995, slope =1.018) The data scatter with this method starts at about 150 mg/dL but is significantly troubling at ~240 mg/dL. This scatter can lead to glucose errors versus the central lab and insulin dosing errors. The Std Deviation of the bias is mg/dL The StatStrip % bias is only 1.09% and the Std Deviation of the bias is only mg/dL! 100 200 300 400 500 600 (mg/dL) Plasma Glucose Reference Method Kost, G. et al AACC, July 07; Diabetes Technology, Oct 07

StatStrip® Correlation Study Comparison
No. 260 StatStrip Glucose Rev. 1/19/2012 StatStrip® Correlation Study Comparison Summary N Slope Intercept (mg/dL) R2 Sy*x (mg/dL) Nova 1703 1.018 -0.716 0.995 9.795 Abbott PCx 559 0.89 0.084 0.9499 33.194 Abbott PX P 225 0.82 18.886 33.15 I Roche 273 1.036 5.002 0.9795 21.197 This table summarizes the significant accuracy differences between competitive glucose monitoring systems and StatStrip from the previous graphs. Of note are: the slope and std deviation values for both Abbott strips The correlation coefficients (R2) for Abbott and Roche The y-intercept and std deviation for Roche and LifeScan LifeScan 628 1.029 -1.505 0.9869 15.532 Kost, G. et al AACC, July 07; Diabetes Technology, Oct 07* * Summary table did not appear in publication

Hematocrit Interference Effect Hematocrit Interference Effect
No. 260 StatStrip Glucose Rev. 1/19/2012 StatStrip® Multi-WellTM Technology Measures and Corrects Hematocrit Interference Hematocrit Interference Effect Hematocrit Interference Effect % Hct 25 Glucose Results Artificially High Up to 25% % Hct 65 Artificially Low Up to 30% % Hct 45 Glucose Results Normal This slide illustrates the hematocrit interference on competitive glucose strips. The circles represents the electrode measurement area for all glucose POC meters. The red dots represent red blood cells. The white space represents the plasma. The more red cells that are present, the less plasma. Since plasma is where the glucose is located, the glucose reading vary by Hct reading. The center circle represents a normal blood sample. 45% of the reaction area is occupied by RBC and 55% is plasma where the glucose is.. Without the ability to measure the patient’s true hematocrit, competitive meters have to use a “normal” hematocrit value to calibrate their measurement algorithms. The further the patient’s actual Hct value is from the chosen calibration point, the higher the error introduced. The circle to the left represents a low hematocrit. At a 25% Hct, there is 50% more plasma and as a result higher glucose readings. The reported glucose is higher that the actual value because the strip is calibrated to a Hct of 45%. Low Hct is very common in the critical care areas. Patients that have experienced trauma, hema-diluted procedures, post-delivery mothers, oncology patients and many others experience anemia’s. The circle to the right is the opposite. A higher Hct has more RBS and less plasma lowering the reported/measured glucose values. NICU and dehydrated patients are among the populations that will experience significant compromised care if your glucose analyzer does not measure and correct for the Hct interference. Only StatStrip MEASURES and CORRECTS for the glucose measurement error caused by a patient’s abnormal hematocrit. (Calibration Point)

No. 260 StatStrip Glucose Rev. 1/19/2012
StatStrip® Multi-WellTM Technology Measures and Corrects Hematocrit Interference 25% 60% 45% Error % Due to Uncorrected Hematocrit Glucose result uncorrected for Hct. Glucose result. Hct measured and corrected. Hematocrit Error from Hct This slide illustrates the hematocrit interference in a different way. The further away from the calibration point or the normal Hct value (45%) the greater the Hct interference. The interference is inversely related to the Hct value. High HCT gives falsely low glucose readings and low Hct gives falsely high glucose readings. Low Hct is the most common of the two conditions and can contribute to falsely high glucose results and overdosing of insulin. Low Hct is therefore potentially more dangerous. As your hospital becomes more aggressive in Glycemic control, the concern is to prevent driving the patient into a hypoglycemic event. If your glucose meter has an interference at a low hematocrit, the meter may read higher glucose values than the patients actual glucose, resulting in a possible insulin over-dose or a delay in identifying a serious hypoglycemic event. StatStrip measures and corrects for hematocrit enabling better glucose accuracy, improved insulin dosing, and reducing the risk of hypoglycemia Low hematocrit causes erroneously high glucose results High hematocrit causes erroneously low glucose results

StatStrip® Multi-WellTM Technology Measures and Corrects Hematocrit Interference
No. 260 StatStrip Glucose Rev. 1/19/2012 Hematocrit Interference Study Nova StatStrip® vs. Current Technology Test Strips StatStrip Abbott Precision Lifescan SureStep Roche Inform Hematocrit (%) Mean glucose difference (mg/dL) - 20 15 10 5 30 40 50 60 70 Glucose = 54 mg/dL True value This slide is from a peer-reviewed published hematocrit interference study performed at the Mayo Clinic in MN. The reference analyzer glucose value is 54 mg/dL (hypoglycemia) The dark green line is the StatStrip. As Hct increases (x-axis) the Mean Glucose Difference (y-axis) for StatStrip remains essentially constant around 0 mg/dL. The blue (Lifescan) and light blue (Abbott PCx) line represent competitive methods. The Hct effect is very evident. These methods show Mean Glucose Differences of mg/dL as the hematocrit is varied from 25 to 68% The red line (Roche Inform) is one of the electrochemical methods. The glucose values track significantly lower (approximately 10 mg/dl) than the reference value. Karon, B. et al, Diabetes Technology and Therapeutics, Apr 2008

No. 260 StatStrip Glucose Rev. 1/19/2012 Hematocrit Interference Study Nova StatStrip® vs. Current Technology Test Strips StatStrip Abbott Precision Lifescan SureStep Roche Inform StatStrip GD Electrochemical GD Electrochemical GO Photometric - 50 40 30 20 10 60 70 Hematocrit (%) Mean glucose difference (%) Glucose = 247 mg/dL True value This graph is for a glucose value of 247 mg/dL (hyperglycemia) The dark green line is the StatStrip. As Hct increases (x-axis) the % Error (y-axis) for StatStrip remains essentially constant around 0% error. At this glucose level however, the competitive methods show glucose differences as much as 30%, as hct is varied from 25 to 68%. This slide is from a peer-reviewed published hematocrit interference study performed at the Mayo Clinic in MN. Karon, B. et al, Diabetes Technology and Therapeutics, Apr 2008;

No. 260 StatStrip Glucose Rev. 1/19/2012 Hematocrit Interference Study Nova StatStrip® vs. Current Technology Test Strips StatStrip Abbott Precision Lifescan SureStep Roche Inform 10 Glucose = 486 mg/dL True value -10 Mean glucose difference (%) -20 -30 This graph is for a glucose value of 486 mg/dL (hyperglycemia) The dark blue line is the StatStrip. As the Hct increases (x-axis) the %Error (y-axis) for StatStrip remains essentially constant around 0% error. At this glucose level however, all three competitive methods show glucose differences as much as 40%, as Hct is varied from 25 to 68%. This slide is from a peer-reviewed published hematocrit interference study performed at the Mayo Clinic in MN. -40 - 50 20 30 40 50 60 70 Hematocrit (%) Karon, B. et al, Diabetes Technology and Therapeutics, Apr 2008

Severe hematocrit abnormalities are extremely common in hospitalized patients
No. 260 StatStrip Glucose Rev. 1/19/2012 Up to 77% of ICU patients an have abnormally low hematocrit (<36%) during their ICU stay1,2 Average HCT at ICU admission: 33-34%2,3 29% have HCT<30%4 HCT declines by an average of % HCT per ICU day1 Patients with abnormal hematocrit values are very prevalent in hospital ICU. These facts provide documentation from the literature that supports the need to have a glucose meter that can measure and correct for hematocrit for these critical patients The Mann paper and Pitcoke paper are excellent proof papers that also support the prevalence of hematocrit (anemia) in ICU patients and how anemia can cause significant glucose meter error. 1. Von Ahsen N et. al., Important role of non-diagnostic blood loss and blunted erythropoietic response in the anemia of medical intensive care patients; Critical Care Medicine: 1999; 27(12); 2.Corwin HL et. al., The Crit Study: Anemia and blood transfusion in the critically ill; current practice in the United States;, Crit Care Med Jan;32(1):30-52 3. T.S. Walsh et. al., Anemia during critical illness;, et. al., British Journal of Anaesthesia 2006, 97(3): 4. Vincent JL, et al. Anemia and blood transfusion in critically ill patients. JAMA 2002 Sep 25; 288(12):

Maltose Interference with Glucose Dehydrogenase (PQQ Mediator) Enzymes
No. 260 StatStrip Glucose Rev. 1/19/2012 Maltose Interference with Glucose Dehydrogenase (PQQ Mediator) Enzymes FDA issued two “Public Health Notices” regarding the dangers of GDH-PQQ glucose test strips. Between 2004 and 2009,thirteen deaths have been reported directly related to the use of GDH-PQQ glucose strips. On August 13, 2009, the FDA clearly stated “Avoid using GDH-PQQ glucose test strips in healthcare facilities” This is an FDA notice warning the health care providers about the significant interference of Maltose on certain glucose meters using the glucose dehydrogenase method. The interference can lead to insulin over-dosing and the serious injury or death. StatStrip has no Maltose, Galactose or Xylose interference. A recent study by Dimeski shows that the newest Roche glucose test strip still exhibits some glucose error in the presence of Maltose and Galactose.

Maltose Interference Studies Nova StatStrip® vs Roche GDH-PQQ Method
No. 260 StatStrip Glucose Rev. 1/19/2012 290 Bed MA Hospital 150 Bed CT Hospital Glucose (mg/dL) Maltose Interference 54 120 180 100 200 Maltose (mg/dL) 199 271 344 380 450 522 StatStrip GDH Glucose (mg/dL) Maltose Interference 54 108 163 100 200 Maltose (mg/dL) Roche 217 280 344 380 460 540 StatStrip GDH This is data from two different hospital studies demonstrating the StatStrip freedom from maltose interference. (Nova Lab evaluations) At a fixed concentration of glucose, increasing levels of maltose show no interference to StatStrip, however the maltose interference on the Roche meter is very significant.. The therapeutic level of Maltose in patients on peritoneal dialysis is approximately mg/dL. Maltose values will be higher in many of the therapies that contain maltose (immunoglobulin or TPN solutions)

Nova StatStrip® Multi-Well Technology Eliminates Calibration Codes
No. 260 StatStrip Glucose Rev. 1/19/2012 Nova StatStrip® Multi-Well Technology Eliminates Calibration Codes TM StatStrip lots are interchangeable Eliminates need for lot change over studies Reduces operator steps Eliminates glucose errors due to miscoding Glucose errors as large as 43% can be caused by an incorrect cal code Baum JM et al. Diabet Technol & Ther 2006 Every other hospital glucose system requires calibration codes. By eliminating the need for calibration codes, StatStrip has ELIMINATED CALIBRATION AS A VARIABLE in glucose measurements. Calibration codes add an extra operator step and can lead to a possible operator error. Given the large number of POC operators and the large number of bedside glucose tests performed, such errors will surely happen. An incorrect cal code can result in a Glucose reading error. Articles have suggested glucose errors due to miscoding can be as high as 40%. All StatStrip lots are consistent and do not require calibration codes

Nova StatStrip® Multi-Well Technology Offers Other Operational Advantages TM 24 month shelf-life from manufacturer 180 day open vial stability Manufacturing lot size up to 8 million strips StatStrip has a long shelf life and open vial stability. Most hospitals will use a vial of test strips long before the 180 day open vial expiration. Large customers can be assured of receiving test strips from the same lot with Nova’s ability to manufacture lots up to 8 million strips!

Nova StatStrip® Multi-Well Technology Creates Significant Performance Improvements TM Top Layer Prevents biohazard exposure Vent hole creates fast sample draw Capillary Layer 1.2 µL sample fill Design eliminates overfill errors Measurement Wells Layer Well 1: Interferences and glucose Well 2: Interferences Well 3: Hematocrit Well 4: Reference (and initiates analysis to eliminate short sampling errors) Gold Layer Noble metal; superb electrochemical stability in all conditions Classic electrochemical measuring surface Excellent electrical properties See Talk Tracks Patent: US#6,287,451;6,837,976;EP# ;CA 2,375,092

Glucose Management of Hospitalized Patients Demands Improved Glucose Strip Performance JCAHO considers insulin to be one of the highest risk medicines in the inpatient setting “POCT glucose meters have now been employed for making therapeutically important insulin dosing decisions. It is essential that the accuracy of these measurements be comparable to those of laboratory analyzers..” Khan A.I. 2006 “Careful assessment of glucose measurement and how it may impact the targets selected in the hospital are critical safety issues in intensive management of hyperglycemia.” Dungan K. 2007 Additional quotes from the literature indicating need for improved glucose strip performance Khan AI et al. The Variability of Results Between Point-of-Care Testing Glucose Meters and the Central Laboratory Analyzer. Arch Pathol Lab Med, Vol 130, Oct 2006 Dungan K et al. Glucose Measurement: Confounding Issues in Setting Targets for Inpatient Management. Diabetes Care, Vol 30, Number 2, Februaly 2007

Glucose Management of Hospitalized Patients Demands Improved Glucose Strip Performance “The inaccuracies of glucose meters occur at the extremes of glucose reportable range (critical values), but in this region the most important and potentially life-threatening decisions concerning therapy must be made.” Vasquez, J. 2005 “Published reports and clinical experience suggest that glucose meters may not be the most accurate and could possibly result in inappropriate insulin dose titration and avoidable adverse events related to glycemic control.” Kanji, S. 2005 “The magnitude of the differences in the glucose values offered by the four different methods of glucose measurement led to frequent clinical disagreements regarding insulin dose titration in the context of an insulin infusion protocol for aggressive glucose control.” Kanji, S. 2005 Additional quotes from the literature indicating need for improved glucose strip performance Kanji S et al. Reliability of point-of-care testing for glucose measurement in critically ill adults. Crit Care Med , Vol.33, No 12, 2005 Vasquez, J et al. Investigating the reliability of POCT glucose meters, Clinical Chemistry, Vol. 51, No. 6, Supplement, 2005

Glucose Error Leads To Insulin Dosing Error1
Glucose Management of Hospitalized Patients Demands Improved Glucose Strip Performance No. 260 StatStrip Glucose Rev. 1/19/2012 Glucose Error Leads To Insulin Dosing Error1 Total Analytical Error Insulin Dosage Error Rate 5% 8-23% 10% 16-45% 15% >5% 2-Step Dosing Error This table summarizes a paper published by Boyd et al at the University of Virginia. These researchers did a statistical model of the effect of glucose meter inaccuracy on proper insulin dosing. Their study finds that: With a glucose total analytical error of 5%, there is a 8 to 23% chance of a One Step error in insulin dosing. (A one-step error is typically two units of insulin) With a glucose total analytical error of 10%, the insulin dosing error rate increases to 16-45%. As the glucose error rate increases, the dosing error rate increases but more importantly, at an error rate of 15%, the possibility of 2-step dosing errors arises. If your meter is reading too high (due to a sample with low Hct, for example) a two step error in insulin dosing increases the chance of driving patients into hypoglycemia. Relate this information back to the correlation graphs! Remember the scatter on the correlation graphs above 150 mg/dl. Incorrect reporting by glucose meters has serious patient safety concerns. Please note: these findings are the RATE of insulin dosing errors. They are not insulin dosing errors 1. Boyd, JD and Bruns, DE. Quality Specifications for Glucose Meters: Assessment by Simulation Modeling of Errors in Insulin Dose. Clinical Chemistry, 47:2, , 2001

98% of Nova Results Satisfy a 10%
No. 260 StatStrip Glucose Rev. 1/19/2012 98% of Nova Results Satisfy a 10% Total Error Limit N=133 patient study at Mayo Clinic Nova StatStrip, Lifescan SureStep, Abbott Precision, Roche Inform Versus Reference Method StatStrip LifeScan Abbott Roche % Bias Cumulative Cumulative Cumulative Cumulative (Error) % of patients % of patients % of patients % of patients ≤5% 75 35 26 35 ADA ≤10% 98 71 56 67 ≤15% 100 94 76 80 ISO 15197 ≤20% This data was obtained from the Mayo Clinic study. An abstract of the data was presented at the 2007 American Association of Clinical Chemistry (AACC). Mayo study looked at correlation of four commercially available hospital glucose meters. This table did not appear in the paper. The Boyd Total Error ranges have been applied to Mayo’s correlation data. The table shows the per cent of data for StatStrip and three commercially available meters that fell within various Total Error ranges versus the central laboratory reference method. Bias limits for the ISO (20%) and ADA recommendations (10%) are also overlayed onto this data. 98% of the StatStrip data fell into the <10% %bias category, whereas only 67% of Roche meter, 56% of meter Lifescan data, and 71% of meter Abbott PCx data, fell into the <10% total error This is the level that the ADA is calling for, so hospitals need to be aware of it now. Note: The ADA call is for Total Error and not %bias. Total Error is Bias + Imprecision. The higher total error rates for competitive meters leads to a higher insulin dosing error rate according to the Boyd paper. This data shows how the improved performance of StatStrip can lead to more accurate glucose testing, improved insulin dosing and improved glycemic control. 100 93 96 ≤25% 100 98 ≤30% 100 Data analysis from Karon, B. et al, Diabetes Technology and Therapeutics, April 2008; not addressed in publication ADA Specification ISO Requirement 36

Fast and Easy Glucose Testing at the Bedside
No. 260 StatStrip Glucose Rev. 1/19/2012 Fast and Easy Glucose Testing at the Bedside This is a slide to transition to the meter presentation

Strip Port Bright, Easy-to-Read Color Touchscreen. Large Easy-to-Use
No. 260 StatStrip Glucose Rev. 1/19/2012 Strip Port Bright, Easy-to-Read Color Touchscreen. Large Easy-to-Use Touchpad. Function Keys On/Off Button August 2007 StatStrip meter is designed for easy, one-hand operation for left or right handed operators. Common functions such as scanning, test strip dosing and data confirmation are performed with the same ease by left or right hand operation. Bar Code Scanner

Fastest Results, 6 seconds Sample Volume, 1.2 µL
No. 260 StatStrip Glucose Rev. 1/19/2012 Fastest Results, 6 seconds Sample Volume, 1.2 µL Easier sample acquisition Enables use of less painful lancets Fewest Operator Steps No calibration codes or calibration chips Strip lot entered automatically by default setting Built-in 1D or 2D barcode scanner Self explanatory—fast, small sample, no cal codes. Point out the ability to scan 2D barcodes. NO OTHER glucose meter does this and we have reference sites using it now. StatStrip® Connectivity Meter

Color Touch Screen Prompts Operator Through Steps
No. 260 StatStrip Glucose Rev. 1/19/2012 Color Touch Screen Prompts Operator Through Steps MED4 Bright, easy to read color touch screen prompts the operator thru simple steps

Operator ID Entered by Scan or Touch Screen
No. 260 StatStrip Glucose Rev. 1/19/2012 Operator ID Entered by Scan or Touch Screen MED4

Meter Then Goes Directly to Patient Test Screen
No. 260 StatStrip Glucose Rev. 1/19/2012 Meter Then Goes Directly to Patient Test Screen MED4 Once the operator logs on, the meter goes directly to the patient test mode, saving keystrokes

Strip Lot Scanned or Entered Automatically
No. 260 StatStrip Glucose Rev. 1/19/2012 Strip Lot Scanned or Entered Automatically By Default Setting MED4 Strip lot can be configured to entered automatically or can require entry every time. The lot is scanned from the vial.

Patient ID (or MRN) Entered by Scan or Touch Screen
No. 260 StatStrip Glucose Rev. 1/19/2012 Patient ID (or MRN) Entered by Scan or Touch Screen MED4

StatStrip® Confirms Valid Patient ID
No. 260 StatStrip Glucose Rev. 1/19/2012 StatStrip® Confirms Valid Patient ID MED4 When connected to ADT, patient data is automatically pushed all the way to the meter. When the Patient data is entered, the meter provides additional confirmation of correct patient ID by providing additional identifiers such as patient name, bed location, date of birth and gender.

Operator Prompted To Final Step
No. 260 StatStrip Glucose Rev. 1/19/2012 Operator Prompted To Final Step MED4 End filled, capillary action, test strips provide fast, easy sample uptake of 1.2 microliters of sample. Under-filling or over-filling of other glucose test strips can lead to gross errors in glucose results.Accufil electronically monitors the blood volume in each of the four measurement wells results are reported only if all four measurement wells are filled with blood.

Results In Only 6 Seconds
No. 260 StatStrip Glucose Rev. 1/19/2012 Results In Only 6 Seconds MED4 StatStrip is the fastest hospital meter. StatStrip can save valuable nursing time especially in those ICUs where nurses are understaffed and where patient testing is performed as frequently as every hour or every half-hour.

Results screen displays all information
No. 260 StatStrip Glucose Rev. 1/19/2012 Results screen displays all information Patient ID Strip Lot Time Operator ID Color, symbols and text allow easy recognition of normal, abnormal and critical ranges Operator can reject results at the meter Repeat testing Optional set-up MED4 One easy-to-read color screen displays: Patient name Patient ID Operator ID Time of analysis Strip lot Test Results Color highlighting, symbols and text provide easy identification of normal, abnormal and critical values Optional sample Reject allows repeat testing

Comments pull-down list customized by:
No. 260 StatStrip Glucose Rev. 1/19/2012 Operator selects comments from a pull-down list or enters via free text Comments pull-down list customized by: Meter location QC, test or sample type Meters can be configured for mandatory comments Multiple comments can be entered for each result Comments can be designated as chartable or non-chartable MED4 MED4 StatStrip has flexible, customizable capability for entry of comments. Canned or free text Customizable by meter location, QC, test, or sample type Can be designated chartable or non-chartable

Manual Test Entry Enables electronic capture of non-connected POC tests using StatStrip infrastructure (ie urinalysis, pregnancy…) Undefined number of manual tests configurable Manual tests are configurable by hospital pre-configured list for results Numeric, +/- Captures QC for manual tests Validate lot numbers

StatStrip® Docking Station
No. 260 StatStrip Glucose Rev. 1/19/2012 StatStrip® Docking Station Provides network connection for data downloading and meter configuration Charges batteries StatStrip docking station provides a data connection to the hospital network for downloading of meter data and uploading of meter configuration and operator messages. A single docking station can accommodate multiple meters. With the meter docked, the meter battery charges. In addition there is a slot for charging a back-up battery.

Comprehensive features for infection control
StatStrip’s durable case has passed the FDA’s rigorous disinfection testing protocol validate with 10,950 cleaning cycles using commercially available cleaning materials including bleach. StatStrip’s disposable, protective bags are available for infection control. Patient barcode scanning and meter operation can be performed with the meter inside the protective bag. Software workflow and operating steps are optimized for infection control: Operator ID and strip lot number are scanned and test strips pre-loaded into the meter outside the patient room The carrying case and extra testing supplies remain outside the patient room per CMS recommendation.

StatStrip® Installation Examples
No. 260 StatStrip Glucose Rev. 1/19/2012 StatStrip® Installation Examples Nova StatStrip® Healthcare Systems Include: Intermountain Health Care System, UT (900+ meters) Manitoba Regional Healthcare, CN (855 meters) William Beaumont Medical Center, MI (379 meters) Johns Hopkins, MD (310 meters) Baptist Health South Florida, FL (250 meters) Northshore University Health System, IL (250 meters) Scripps Health, CA (400 meters) ROi, MO (1000 meters) Yale New Haven Health System, CT (500 meters) Duke University Health System, NC (400 meters) Kaiser Health, USA (2500 meters) Nova has placed StatStrip in over 200 hospitals in the last 3 years installations including many large hospitals and several multi-hospital systems.

StatStrip® Installation Examples
No. 260 StatStrip Glucose Rev. 1/19/2012 StatStrip® Installation Examples Largest Healthcare System Implementation Intermountain Healthcare System, UT - 21 Hospitals - 60+ clinics meters - 8,000+ operators trained Self explanatory

Reimbursement

StatStrip® CPT Code No. 260 StatStrip Glucose Rev. 1/19/2012
Codemap is an industry expert in medical reimbursement. Codemap has clearly established that the CPT #82947 is the correct CPT code for StatStrip. CodeMap is available as a consultant to provide guidance on billing issues and CPT code determination for its StatStrip customers. Customers can visit the Codemap web site or call the phone number provided to speak to a live person for specific questions.

StatStrip® Reimbursement
No. 260 StatStrip Glucose Rev. 1/19/2012 StatStrip is the only glucose test strip developed specifically for professional use in the hospital, and cleared by the FDA for that intended use. The reimbursement code for StatStrip® is Two CPT codes for glucose: 82947 – Quantitative; glucose, blood $5.62 (StatStrip®) 82962 – Glucose; blood by monitoring device $3.27 (FDA cleared specifically for home use) Additional reimbursement for CPT Code # $2.35 At an outpatient usage of 5%, hospital revenues would increase by the following amounts over a 5 year contract Five Year Approximate Increased Total Strip Usage Meters in Use Hospital Revenue 2 million $235,000 4 million $470,000 6 million $705,000 8 million $940,000 (All other glucose strips) StatStrip is the only glucose test strip developed specifically for professional use in the hospital, and cleared by the FDA for that intended use. All the competitive strips were originally FDA cleared for use as consumer meters. Once the consumer strips were approved, the path for the connectivity or hospital meters using the same strips is significantly easier. Since the strips are already cleared, the competitors only had to show that their connectivity meter produced the same results as the previously cleared consumer meters. This slide shows the additional revenue that would accrue to a hospital using StatStrip vs. any other glucose monitor cleared for home use.

Connectivity Overview
No. 260 StatStrip Glucose Rev. 1/19/2012 Connectivity Overview

Comprehensive, Cost Effective POC Connectivity
Scalable connectivity from single hospital to multi-hospital systems Provides a single connectivity solution for all POC device types - Both wired and wireless connections - Manual test entry of off line tests Comprehensive data management and reporting tools Single device-type fee for StatStrip and StatSensor meters StatStrip and StatSensor meters eliminate the need for costly terminal server devices (Lantronix, Dawning).

Meters Meter Configuration Data Management Lab/Hospital Information Systems Nova Connects

Control of point-of-care devices, operators and usage for compliance with point-of-care program requirements Capture of point-of-care data for analyzing, reporting and sharing Connect point-of-care testing to multiple data receivers including LIS, HIS and EMR Compatible with all “Open Connectivity” to all middleware providers

Management and Control of Bedside Glucose Testing
No. 260 StatStrip Glucose Rev. 1/19/2012 Management and Control of Bedside Glucose Testing NovaNet Instrument Manager StatStrip® meters can be customized by location Assign operators and privileges Assign normal, abnormal and critical ranges Assign mandatory fields Establish download/docking requirements Establish QC requirements Pass/fail or numeric option, QC frequency, lockout or prompting Flag results for Tight Glycemic Control Reject results for repeat testing Structure patient ID or MRN NovaNet provides customization, management and control of StatStrip meters, by meter location, including these features…..

Management and Control of Bedside Glucose Testing
No. 260 StatStrip Glucose Rev. 1/19/2012 Management and Control of Bedside Glucose Testing NovaNet Instrument Manager Program coordinator can send a text message to specific operator or group of operators with an optional “I read this message” acknowledgment Multiple options for appending comments to patient or QC results By meter location By QC or test type Preset or free text Chartable or non-chartable NovaNet instrument manager manages all aspects of meter setup and configuration. It also allows an administrator to broadcast messages to all meters that must be acknowledged when the user logs in to use StatStrip for the day. StatStrip also allows multiple types of comments directly on the meter.

NovaConnects: Manual Test Entry
Manual test results can be entered through the StatStrip touch screen interface. Data is captured through NovaConnects infrastructure Manual tests are configurable by the hospital - Manual tests can be quantitative or qualitative - QC is also captured An unlimited number of manual tests can be configured

Integrated Management and Control of Bedside Testing
No. 260 StatStrip Glucose Rev. 1/19/2012 Integrated Management and Control of Bedside Testing Nova has worked with virtually all LIS and HIS vendors to provide fully integrated connectivity solutions that include: Complete data management and reporting Operator certification management Electronic (EDI) or scripted interfacing Full support for unsolicited result reporting to the LIS Hospital defined rules for result exception management Consolidated interface for all connected POC device types StatStrip has proven, existing connectivity to lab and hospital information systems In addition to LIS connectivity, Nova’s middleware vendors provide comprehensive data management including certification and performance reports; data mining, filtering and sorting capabilities; and documentation for regulatory compliance.

Capture all data for patient, device, operator and regulatory records
Create standard or customized reports from a large report library Results exceptions Interface exceptions Results repository QA statistics Levy-Jennings Program utilization Operator Certifications Turnaround Time Results Reports Protocol Reports Program Summary Device Summary: Active devices, device location assignment, last upload Operations reports including; Operator recertification due, Daily workload, Device error events, Overdue device docking, Reporting exceptions.

Flexible network connections meet variable needs throughout hospital

Nova Wireless Connectivity Options
No. 260 StatStrip Glucose Rev. 1/19/2012 Nova Wireless Connectivity Options Wireless Bridge - Wireless connection from docking station provides access to Wifi network. - Cost effective vs. installing new network drops Uses Cisco Linksys WET-200, or other off-the-shelf components Not Portable Nova Wireless Tote - Integrated docking station and transmitter in tote - “Always On” connection - Portable - No meter connectivity reconfiguration - Rechargeable battery For installations in older facilities where network wiring may be an issue, Nova provides connectivity through wireless docking stations. The docks can be placed anywhere and data will be transmitted by b/g/n wireless protocol to the data management server. Nova also offers a wireless carrying case (tote) option. The wireless tote allows patient data and ADT information to be transmitted to/from the LIS/HIS at the point of care.

Non-proprietary, Open Connectivity
Enables connections to all POC devices, regardless of manufacture Eliminates connectivity lock-out which limits POC device choice. Allows hospitals to make POC device decisions based on device needs and benefits Removes cost of middleware conversion as a barrier to acquiring new POC devices

Nova ConnectsTM and Telcor, Inc. or Alere Informatics
No. 260 StatStrip Glucose Rev. 1/19/2012 Nova ConnectsTM and Telcor, Inc. or Alere Informatics Proven success with virtually every LIS and HIS vendor Electronic Data Interface (EDI) or Script-in enables unsolicited results reporting into LIS or HIS Provides a single interface for virtually all POC devices from all vendors Manages data flow by hospital-specific exceptions rules StatStrip connectivity partners provide proven success with virtually every LIS and HIS vendor. EDI and scripted interfaces are available, as well as interfaces for POC devices from other vendors.

Telcor QML QML provides - Complete data management
No. 260 StatStrip Glucose Rev. 1/19/2012 Telcor QML QML provides - Complete data management - ADT data messaging to NovaNet for positive patient ID at the meter - Hospital defined rules for result exception management - Consolidated interface for all connected POC device types Telcor QML middleware handles data management and connectivity to the LIS/HIS. Nova’s NovaNet is used to configure the meters and QML takes over the rest of the data management duties including ADT support for positive patient ID.

Alere Informatics-RALS
RALS provides - Complete data management - ADT data messaging for positive patient ID at the meter - Hospital defined rules for results exception management - Consolidated interface for all connected POC device types

StatStrip® Multi-Well Technology Creates A New Level of Analytical Performance TM “The StatStrip glucose meter correlated best with a plasma hexokinase reference method over a wide range of glucose concentrations and was least significantly impacted by sample hematocrit and other interfering substances. This should allow for better management of critically ill patients on intensive insulin therapy resulting in better glycemic control with improved outcomes and patient safety..” StatStrip is the first meter and strip designed for the current, more demanding requirements of bedside glucose testing. These demands include the need for lab-like analytical performance, freedom from common interferences such as hematocrit and drugs, and elimination of operator technique and operator errors. StatStrip lab-like analytical performance is coupled with the fastest analysis time, the smallest sample size of any hospital meter, plus many other excusive features for bedside glucose testing. This quote from Brad Karon at the Mayo Clinic summarizes the performance and benefits of the StatStrip Hospital Glucose Monitoring System Karon, B. et al, Diabetes Technology and Therapeutics, Apr 2008;

Hospital Glucose Monitoring System
No. 260 StatStrip Glucose Rev. 1/19/2012 Hospital Glucose Monitoring System Hospital Glucose Meter Thank You

Hospital Glucose Monitoring System

Similar presentations

Presentation on theme: "Hospital Glucose Monitoring System"— Presentation transcript:

Similar presentations

About project

Feedback

Log in

Auth with social network:

Hospital Glucose Monitoring System

Similar presentations

Presentation on theme: "Hospital Glucose Monitoring System"— Presentation transcript:

Similar presentations

About project

Feedback