2Nova is the World Leader in Whole Blood Biosensors No. 260 StatStrip Glucose Rev. 1/19/2012Nova BioSensor Firsts1978 First biosensor for Ionized Calcium1980 First biosensor to measure Chloride in blood1984 First biosensor to measure Total Calcium1985 First biosensor to measure Hematocrit by ISE/Conductivity1987 First biosensor to directly measure whole blood Glucose1988 First biosensor to measure Lithium1990 First biosensor to measure BUN (urea)1992 First biosensor to directly measure whole blood Lactate1994 First biosensor to measure Ionized Magnesium1996 First biosensor to measure Creatinine1996 First biosensor to measure Total CO2 in whole blood1997 First multi-wavelength fiber optic SO2% assay1998 First fiber optic Hemoglobin assay1998 First Ammonium biosensor1999 First non-diluting direct Glutamine biosensor1999 First non-diluting direct Glutamate biosensor2001 First Acetate biosensor2005 First Hematocrit corrected Glucose strip2007 First calibration free Glucose strip2007 First Creatinine strip and meter2009 First calibration free Ketone strip2009 First IgG assay on a biotechnology analyzer2011 First Hematocrit corrected hospital Lactate meter and stripNova 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.
3Nova Brand Products No. 260 StatStrip Glucose Rev. 1/19/2012 Stat Profile® pHOx UltraTest Menu: pH, PCO2, PO2, SO2%, Hct,Hb, Na+, K+, Cl-, Ca++, Mg++, TCO2, Glu,BUN, Creat, Lac, HHb, O2Hb, Methb,COHb, O2Ct, O2Cap, tBilSamples: Whole blood, Serum, PlasmaStat Profile® pHOxTest Menu: pH, PCO2, PO2, SO2%, Hct,Hb, Na+, K+, Cl-, Ca++, Glu, LacSamples: Whole blood, Serum, PlasmaNova Chemistry AnalyzersTest Menu: Na+, K+, Cl-, TCO2, Ca++,Mg++, Li+, TCa, Glu, BUN, Crea, Hct, pHSamples: Whole blood, Serum, PlasmaNova BioProfile FLEX™Test Menu: Gluc, Lac, Gln, Glu, NH4+, pH,PO2, PCO2, Na+, K+, Ca++, CD, CV, Osm,IgG, PO4Samples: 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: GlucoseSamples: Whole bloodNova StatStrip®Test Menu: Glucose/KetoneSamples: Whole bloodNova StatStrip®Test Menu: LactateSamples: Whole bloodNova StatSensor®Test Menu: CreatinineSamples: Whole bloodNova MAX® PlusTest Menu: Glucose/KetoneSamples: Whole bloodNova MAX® Link ®Test Menu: GlucoseSamples: Whole bloodNova Lactate Plus ®Test Menu: LactateSamples: Whole blood* Currently Available outside the U.S.
13Nova Multi-Well Technology Creates A New Level of Analytical Performance No. 260 StatStrip Glucose Rev. 1/19/2012TMHospital Glucose MeterHospital Glucose Meter
14Laboratory quality accuracy and precision from 10 to 600 mg/dL No. 260 StatStrip Glucose Rev. 1/19/2012Hospital Glucose MeterThe World’s Most Accurate Hospital Glucose MeterProven in Over 60 Published Hospital Evaluations WorldwideLaboratory quality accuracy and precision from 10 to 600 mg/dLMeasures and corrects interferences from:- Hematocrit- Electrochemical interferences including acetaminophen, ascorbic acid, and uric acidNo maltose, galactose, xylose or oxygen interferenceEliminates calibration codesFastest results, 6 secondsSmall sample, 1.2 µL whole bloodNova Connects™, Total POC Connectivity SolutionStatStrip 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/dLStatStrip also eliminates calibration codes required of all other hospital meters. This eliminates an operator step and a source of operator errorStatStrip 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
15StatStrip® Has Earned Worldwide Scientific Acclaim No. 260 StatStrip Glucose Rev. 1/19/2012StatStrip® Has Earned Worldwide Scientific AcclaimThe 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.
16StatStrip® Multi-Well Technology Correlation Study No. 260 StatStrip Glucose Rev. 1/19/2012StatStrip® Multi-Well Technology Correlation StudyTMR2:SLOPE: 1.018INTERCEPT: mmol/LINTERCEPT: mg/dLN=1703Sy*x = 0.54 mmol/LSy*x = mg/dL(mmol/L)70060040030020010050033.35.611.116.722.227.838.9(mg/dL)(mmol/L)Nova StatStrip Whole Blood GlucoseThis 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/dLIt 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 MethodKost, G. et al AACC, July 07;Diabetes Technology, Oct 0716
17Abbott PCx Correlation Study No. 260 StatStrip Glucose Rev. 1/19/2012Abbott PCx Correlation StudyR2:SLOPE: 0.89INTERCEPT: 0.00 mmol/LINTERCEPT: mg/dLN=559Sy*x = 1.84 mmol/LSy*x = mg/dL(mmol/L)5.611.116.722.227.833.370038.960033.350027.840022.2(mg/dL)(mmol/L)Abbott PCx Whole Blood Glucose30016.720011.11005.6This 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.100200300400500600(mg/dL)Plasma Glucose Reference MethodKost, G. et al AACC, July 07;Diabetes Technology, Oct 07
18Abbott PXP Correlation Study No. 260 StatStrip Glucose Rev. 1/19/2012Abbott PXP Correlation StudyR2:SLOPE: 0.820INTERCEPT: 1.05 mmol/LINTERCEPT: mg/dLN=225Sy*x = 1.8 mmol/LSy*x = mg/dL(mmol/L)5.611.116.722.227.833.360033.350027.840022.2(mg/dL)(mmol/L)30016.7Abbott PXP Whole Blood Glucose20011.11005.6This 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 improved100200300400500600(mg/dL)Plasma Glucose Reference MethodKost, G. et al AACC, July 07;Diabetes Technology, Oct 07
19LifeScan SureStep Correlation Study No. 260 StatStrip Glucose Rev. 1/19/2012R2:SLOPE: 1.029INTERCEPT: mmol/LINTERCEPT: mg/dLN=628Sy*x = 0.86 mmol/LSy*x = mg/dL700600400300200100500LifeScan Whole Blood Glucose38.9(mmol/L)33.35.611.116.722.227.8(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/dLThe Std Deviation of StatStrip bias is only mg/dL.Plasma Glucose Reference MethodKost, G. et al AACC, July 07;Diabetes Technology, Oct 07
20Roche Accu-Chek Correlation Study No. 260 StatStrip Glucose Rev. 1/19/2012Roche Accu-Chek Correlation StudyR2:SLOPE: 1.036INTERCEPT: 0.28 mmol/LINTERCEPT: mg/dLN=273Sy*x = 1.18 mmol/LSy*x = mg/dL(mmol/L)5.611.116.722.227.833.370038.960033.350027.840022.2(mg/dL)(mmol/L)Roche Whole Blood Glucose30016.720011.11005.6This 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/dLThe StatStrip % bias is only 1.09% and the Std Deviation of the bias is only mg/dL!100200300400500600(mg/dL)Plasma Glucose Reference MethodKost, G. et al AACC, July 07;Diabetes Technology, Oct 07
21StatStrip® Correlation Study Comparison No. 260 StatStrip Glucose Rev. 1/19/2012StatStrip® Correlation Study ComparisonSummaryNSlopeIntercept(mg/dL)R2Sy*x(mg/dL)Nova17031.018-0.7160.9959.795Abbott PCx5590.890.0840.949933.194Abbott PXP2250.8218.88633.15IRoche2731.0365.0020.979521.197This 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 stripsThe correlation coefficients (R2) for Abbott and RocheThe y-intercept and std deviation for Roche and LifeScanLifeScan6281.029-1.5050.986915.532Kost, G. et al AACC, July 07;Diabetes Technology, Oct 07** Summary table did not appear in publication
22Hematocrit Interference Effect Hematocrit Interference Effect No. 260 StatStrip Glucose Rev. 1/19/2012StatStrip® Multi-WellTM Technology Measures and Corrects Hematocrit InterferenceHematocrit Interference EffectHematocrit Interference Effect% Hct 25Glucose ResultsArtificially HighUp to 25%% Hct 65Artificially LowUp to 30%% Hct 45Glucose ResultsNormalThis 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)
23No. 260 StatStrip Glucose Rev. 1/19/2012 StatStrip® Multi-WellTM Technology Measures and Corrects Hematocrit Interference25%60%45%Error % Due to Uncorrected HematocritGlucose resultuncorrected for Hct.Glucose result.Hct measuredand corrected.HematocritError from HctThis 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 hypoglycemiaLow hematocrit causes erroneously high glucose resultsHigh hematocrit causes erroneously low glucose results
24StatStrip® Multi-WellTM Technology Measures and Corrects Hematocrit Interference No. 260 StatStrip Glucose Rev. 1/19/2012Hematocrit Interference Study Nova StatStrip® vs. Current Technology Test StripsStatStripAbbott PrecisionLifescan SureStepRoche InformHematocrit(%)Mean glucose difference (mg/dL)-20151053040506070Glucose = 54 mg/dLTrue valueThis 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
25StatStrip® Multi-WellTM Technology Measures and Corrects Hematocrit Interference No. 260 StatStrip Glucose Rev. 1/19/2012Hematocrit Interference Study Nova StatStrip® vs. Current Technology Test StripsStatStripAbbott PrecisionLifescan SureStepRoche InformStatStripGD ElectrochemicalGD ElectrochemicalGO Photometric-50403020106070Hematocrit(%)Mean glucose difference (%)Glucose = 247 mg/dLTrue valueThis 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;
26StatStrip® Multi-WellTM Technology Measures and Corrects Hematocrit Interference No. 260 StatStrip Glucose Rev. 1/19/2012Hematocrit Interference Study Nova StatStrip® vs. Current Technology Test StripsStatStripAbbott PrecisionLifescan SureStepRoche Inform10Glucose = 486 mg/dLTrue value-10Mean glucose difference (%)-20-30This 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.-40-50203040506070Hematocrit(%)Karon, B. et al, Diabetes Technology and Therapeutics, Apr 2008
27Severe hematocrit abnormalities are extremely common in hospitalized patients No. 260 StatStrip Glucose Rev. 1/19/2012Up to 77% of ICU patients an have abnormally low hematocrit (<36%) during their ICU stay1,2Average HCT at ICU admission:33-34%2,329% have HCT<30%4HCT declines by an average of % HCT per ICU day1Patients 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 patientsThe 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):30-523. 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):
28Maltose Interference with Glucose Dehydrogenase (PQQ Mediator) Enzymes No. 260 StatStrip Glucose Rev. 1/19/2012Maltose Interference with Glucose Dehydrogenase (PQQ Mediator) EnzymesFDA 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.
29Maltose Interference Studies Nova StatStrip® vs Roche GDH-PQQ Method No. 260 StatStrip Glucose Rev. 1/19/2012290 Bed MA Hospital150 Bed CT HospitalGlucose (mg/dL)Maltose Interference54120180100200Maltose (mg/dL)199271344380450522StatStripGDHGlucose (mg/dL)Maltose Interference54108163100200Maltose (mg/dL)Roche217280344380460540StatStripGDHThis 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)
30Nova StatStrip® Multi-Well Technology Eliminates Calibration Codes No. 260 StatStrip Glucose Rev. 1/19/2012Nova StatStrip® Multi-Well Technology Eliminates Calibration CodesTMStatStrip lots are interchangeableEliminates need for lot change over studiesReduces operator stepsEliminates glucose errors due to miscodingGlucose errors as large as 43% can be caused by an incorrect cal codeBaum JM et al. Diabet Technol & Ther 2006Every 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
31No. 260 StatStrip Glucose Rev. 1/19/2012 Nova StatStrip® Multi-Well Technology Offers Other Operational AdvantagesTM24 month shelf-lifefrom manufacturer180 day open vial stabilityManufacturing lot size up to8 million stripsStatStrip 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!
33No. 260 StatStrip Glucose Rev. 1/19/2012 Glucose Management of Hospitalized Patients Demands Improved Glucose Strip PerformanceJCAHO 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. 2007Additional quotes from the literature indicating need for improved glucose strip performanceKhan 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 2006Dungan K et al. Glucose Measurement: Confounding Issues in Setting Targets for Inpatient Management. Diabetes Care, Vol 30, Number 2, Februaly 2007
34No. 260 StatStrip Glucose Rev. 1/19/2012 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. 2005Additional quotes from the literature indicating need for improved glucose strip performanceKanji S et al. Reliability of point-of-care testing for glucose measurement in critically ill adults. Crit Care Med , Vol.33, No 12, 2005Vasquez, J et al. Investigating the reliability of POCT glucose meters, Clinical Chemistry, Vol. 51, No. 6, Supplement, 2005
35Glucose Error Leads To Insulin Dosing Error1 Glucose Management of Hospitalized Patients Demands Improved Glucose Strip PerformanceNo. 260 StatStrip Glucose Rev. 1/19/2012Glucose Error Leads To Insulin Dosing Error1Total Analytical ErrorInsulinDosage Error Rate5%8-23%10%16-45%15%>5% 2-Step Dosing ErrorThis 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 errors1. Boyd, JD and Bruns, DE. Quality Specifications for Glucose Meters: Assessment by Simulation Modeling of Errors in Insulin Dose. Clinical Chemistry, 47:2, , 2001
3698% of Nova Results Satisfy a 10% No. 260 StatStrip Glucose Rev. 1/19/201298% of Nova Results Satisfy a 10%Total Error LimitN=133 patient study at Mayo ClinicNova StatStrip, Lifescan SureStep, Abbott Precision, Roche InformVersus Reference MethodStatStripLifeScanAbbottRoche% BiasCumulativeCumulativeCumulativeCumulative(Error)% of patients% of patients% of patients% of patients≤5%75352635ADA≤10%98715667≤15%100947680ISO15197≤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 errorThis 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.1009396≤25%10098≤30%100Data analysis from Karon, B. et al, Diabetes Technology and Therapeutics, April 2008; not addressed in publicationADA SpecificationISO Requirement36
37Fast and Easy Glucose Testing at the Bedside No. 260 StatStrip Glucose Rev. 1/19/2012Fast and Easy Glucose Testing at the BedsideThis is a slide to transition to the meter presentation
38Strip Port Bright, Easy-to-Read Color Touchscreen. Large Easy-to-Use No. 260 StatStrip Glucose Rev. 1/19/2012Strip PortBright, Easy-to-ReadColor Touchscreen.Large Easy-to-UseTouchpad.Function KeysOn/Off ButtonAugust 2007StatStrip 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
39Fastest Results, 6 seconds Sample Volume, 1.2 µL No. 260 StatStrip Glucose Rev. 1/19/2012Fastest Results, 6 secondsSample Volume, 1.2 µLEasier sample acquisitionEnables use of less painful lancetsFewest Operator StepsNo calibration codes or calibration chipsStrip lot entered automatically by default settingBuilt-in 1D or 2D barcode scannerSelf 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
40Color Touch Screen Prompts Operator Through Steps No. 260 StatStrip Glucose Rev. 1/19/2012Color Touch Screen Prompts Operator Through StepsMED4Bright, easy to read color touch screen prompts the operator thru simple steps
41Operator ID Entered by Scan or Touch Screen No. 260 StatStrip Glucose Rev. 1/19/2012Operator ID Entered by Scan or Touch ScreenMED4
42Meter Then Goes Directly to Patient Test Screen No. 260 StatStrip Glucose Rev. 1/19/2012Meter Then Goes Directly to Patient Test ScreenMED4Once the operator logs on, the meter goes directly to the patient test mode, saving keystrokes
43Strip Lot Scanned or Entered Automatically No. 260 StatStrip Glucose Rev. 1/19/2012Strip Lot Scanned or Entered AutomaticallyBy Default SettingMED4Strip lot can be configured to entered automatically or can require entry every time. The lot is scanned from the vial.
44Patient ID (or MRN) Entered by Scan or Touch Screen No. 260 StatStrip Glucose Rev. 1/19/2012Patient ID (or MRN) Entered by Scan or Touch ScreenMED4
45StatStrip® Confirms Valid Patient ID No. 260 StatStrip Glucose Rev. 1/19/2012StatStrip® Confirms Valid Patient IDMED4When 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.
46Operator Prompted To Final Step No. 260 StatStrip Glucose Rev. 1/19/2012Operator Prompted To Final StepMED4End 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.
47Results In Only 6 Seconds No. 260 StatStrip Glucose Rev. 1/19/2012Results In Only 6 SecondsMED4StatStrip 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.
48Results screen displays all information No. 260 StatStrip Glucose Rev. 1/19/2012Results screen displays all informationPatient IDStrip LotTimeOperator IDColor, symbols and text alloweasy recognition of normal,abnormal and critical rangesOperator can reject results at the meterRepeat testingOptional set-upMED4One easy-to-read color screen displays:Patient namePatient IDOperator IDTime of analysisStrip lotTest ResultsColor highlighting, symbols and text provide easy identification of normal, abnormal and critical valuesOptional sample Reject allows repeat testing
49Comments pull-down list customized by: No. 260 StatStrip Glucose Rev. 1/19/2012Operator selects comments from a pull-down list or enters via free textComments pull-down list customized by:Meter locationQC, test or sample typeMeters can be configured for mandatory commentsMultiple comments can be entered for each resultComments can be designated as chartable or non-chartableMED4MED4StatStrip has flexible, customizable capability for entry of comments.Canned or free textCustomizable by meter location, QC, test, or sample typeCan be designated chartable or non-chartable
50Manual Test EntryEnables electronic capture of non-connected POC tests using StatStrip infrastructure (ie urinalysis, pregnancy…)Undefined number of manual tests configurableManual tests are configurable by hospitalpre-configured list for resultsNumeric,+/-Captures QC for manual testsValidate lot numbers
51StatStrip® Docking Station No. 260 StatStrip Glucose Rev. 1/19/2012StatStrip® Docking StationProvides network connectionfor data downloading andmeter configurationCharges batteriesStatStrip 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.
52Comprehensive 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 roomThe carrying case and extra testing supplies remain outside the patient room per CMS recommendation.
53StatStrip® Installation Examples No. 260 StatStrip Glucose Rev. 1/19/2012StatStrip® Installation ExamplesNova 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.
56StatStrip® 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.
57StatStrip® Reimbursement No. 260 StatStrip Glucose Rev. 1/19/2012StatStrip 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® isTwo 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 # $2.35At an outpatient usage of 5%, hospital revenues would increase by the following amounts over a 5 year contractFive Year Approximate Increased TotalStrip Usage Meters in Use Hospital Revenue2 million $235,0004 million $470,0006 million $705,0008 million $940,000(All otherglucose 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.
59Comprehensive, Cost Effective POC Connectivity Scalable connectivity from single hospital to multi-hospital systemsProvides a single connectivity solution for all POC device types- Both wired and wireless connections- Manual test entry of off line testsComprehensive data management and reporting toolsSingle device-type fee for StatStrip and StatSensor metersStatStrip and StatSensor meters eliminate the need for costly terminal server devices (Lantronix, Dawning).
61Control of point-of-care devices, operators and usage for compliance with point-of-care program requirementsCapture of point-of-care data for analyzing, reporting and sharingConnect point-of-care testing to multiple data receivers including LIS, HIS and EMRCompatible with all “Open Connectivity” to all middleware providers
62Management and Control of Bedside Glucose Testing No. 260 StatStrip Glucose Rev. 1/19/2012Management and Control of Bedside Glucose TestingNovaNet Instrument ManagerStatStrip® meters can be customized by locationAssign operators and privilegesAssign normal, abnormal and critical rangesAssign mandatory fieldsEstablish download/docking requirementsEstablish QC requirementsPass/fail or numeric option,QC frequency, lockout or promptingFlag results for Tight Glycemic ControlReject results for repeat testingStructure patient ID or MRNNovaNet provides customization, management and control of StatStrip meters, by meter location, including these features…..
63Management and Control of Bedside Glucose Testing No. 260 StatStrip Glucose Rev. 1/19/2012Management and Control of Bedside Glucose TestingNovaNet Instrument ManagerProgram coordinator can send a text message to specific operator or group of operators with an optional “I read this message” acknowledgmentMultiple options for appending comments to patient or QC resultsBy meter locationBy QC or test typePreset or free textChartable or non-chartableNovaNet 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.
64NovaConnects: Manual Test Entry Manual test results can be entered through the StatStrip touch screen interface.Data is captured through NovaConnects infrastructureManual tests are configurable by the hospital- Manual tests can be quantitative or qualitative- QC is also capturedAn unlimited number of manual tests can be configured
65Integrated Management and Control of Bedside Testing No. 260 StatStrip Glucose Rev. 1/19/2012Integrated Management and Control of Bedside TestingNova has worked with virtually all LIS and HIS vendors to provide fully integrated connectivity solutions that include:Complete data management and reportingOperator certification managementElectronic (EDI) or scripted interfacingFull support for unsolicited result reporting to the LISHospital defined rules for result exception managementConsolidated interface for all connected POC device typesStatStrip has proven, existing connectivity to lab and hospital information systemsIn 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.
66Capture all data for patient, device, operator and regulatory records Create standard or customized reports from a large report libraryResults exceptionsInterface exceptionsResults repositoryQA statisticsLevy-JenningsProgram utilizationOperator CertificationsTurnaround TimeResults ReportsProtocol ReportsProgram SummaryDevice Summary: Active devices, device location assignment, last uploadOperations reports including;Operator recertification due,Daily workload,Device error events,Overdue device docking,Reporting exceptions.
67Flexible network connections meet variable needs throughout hospital
68Nova Wireless Connectivity Options No. 260 StatStrip Glucose Rev. 1/19/2012Nova Wireless Connectivity OptionsWireless Bridge- Wireless connection from docking station provides access to Wifi network.- Cost effective vs. installing new network dropsUses Cisco Linksys WET-200, or other off-the-shelf componentsNot PortableNova Wireless Tote- Integrated docking station and transmitter in tote- “Always On” connection- Portable- No meter connectivity reconfiguration- Rechargeable batteryFor 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.
69Non-proprietary, Open Connectivity Enables connections to all POC devices, regardless of manufactureEliminates connectivity lock-out which limits POC device choice.Allows hospitals to make POC device decisions based on deviceneeds and benefitsRemoves cost of middleware conversion as a barrier to acquiringnew POC devices
70Nova ConnectsTM and Telcor, Inc. or Alere Informatics No. 260 StatStrip Glucose Rev. 1/19/2012Nova ConnectsTM and Telcor, Inc. or Alere InformaticsProven success with virtually every LIS and HIS vendorElectronic Data Interface (EDI) or Script-in enables unsolicited results reporting into LIS or HISProvides a single interface for virtually all POC devices from all vendorsManages data flow by hospital-specific exceptions rulesStatStrip 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.
71Telcor QML QML provides - Complete data management No. 260 StatStrip Glucose Rev. 1/19/2012Telcor QMLQML 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 typesTelcor 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.
72Alere 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
73No. 260 StatStrip Glucose Rev. 1/19/2012 StatStrip® Multi-Well Technology Creates A New Level of Analytical PerformanceTM“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 SystemKaron, B. et al, Diabetes Technology and Therapeutics, Apr 2008;
74Hospital Glucose Monitoring System No. 260 StatStrip Glucose Rev. 1/19/2012Hospital Glucose Monitoring SystemHospital Glucose MeterThank You