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StatStrip Glucose- Setting new Standardsin Glucose POC meter testing?

Professor Roger Clampitt,

Consultant Chemical Pathologist

Outline of Presentation

• What is the current status of POC glucosemeter testing in hospitals?

• StatStrip® Glucose: first point of care glucosemeter to correct for interferences

• StatStrip® Glucose: improving the accuracy ofglucose measurements

Hospital Glucose testing

• Managing and maintaining glucose levels in critically ill

hospitalised patients reduces mortality and morbidityrates as well as length of stay.

• Protocols for maintaining safe and effective glycaemic

control are widely implemented

• Hospital glucose testing now widely established and is a

high volume test parameter

• POC Glucose meters most commonly used procedure

for measuring glucose values throughout a hospital.

However

� Accurate results are required to manageglycemic control and insulin dosing.

� The blood sample composition of hospitalisedpatients will contain components that can

influence the results of diagnostic tests.

� There is increasing awareness that the accuracyof most commonly used glucose meters areaffected by HCT and interfering substances

commonly present in hospitalised patients

Many Factors affect Glucose meter measurements

↑↑↑↑Mannitol

↑↑↑↑Icodextrin / maltose

↓↓↓↓Dopamine

↑↑↑↑↓↓↓↓Acetaminophen

↑↑↑↑ / ↓↓↓↓Ascorbic acid

Therapeutic Agents

↓↓↓↓ Oxygen therapy

↑↑↑↑ Hypoxia

Oxygen concentration

↓↓↓↓↓↓↓↓ High HCT

↑↑↑↑↑↑↑↑ Low HCT

Haematocrit

Glucose

dehydrogenase

Glucose

oxidase

Dungan, K et al, Glucose Measurement:Confounding Issues in Setting Targets forInpatient Management, Diabetes Care, Feb 2007

Severe haematocritabnormalities are routinelyfound in critically ill patients

• NICU patients

• Open heart surgery

• Dialysis patients

• Oncology patients

• Trauma patients

• Severely anaemic patients

• Elderly patients

-30%

-20%

-10%

0%

10%

20%

30%

25% 60%45%

Error % Due to Uncorrected Haematocrit

Glucose resultuncorrected for Hct.

Glucose result.Hct measuredand corrected.

Haematocrit

Err

or

fro

m H

ct

Haematocrit Interference Effect

60

40

20

0

-20

-40

0.2 0.4 0.6

Difference between PCx and PG (%)

Hematocrit (l/l)

Hematocrit Interference Effect

Balion C et al. Screening for hypoglycemia at thebedside in the neonatal intensive care unit (NICU)with the Abbott PCx glucose meter. BMC Pediatr.2006 Nov 3;6:28.

Hamilton Health Sciences Study, Hamilton, Ontario, Canada

Effect of hematocrit

on glucose

measurementsperformed on the

PCx and in the

central laboratory

(PG)

Accuracy of Current meters

Thomas A et al An evaluation of the

analytical performance of a new

generation hospital based glucose

meter and an assessment of its clinical

reliability in a neonatal care unit..Poster

presentation 22nd International AACC

CPOCT Barcelona 17-20 September

2008

YesYesAccuChek Advantage

Karon BS et al. Evaluation of the

Impact of Hematocrit and Other

Interference on the Accuracy of

Hospital-Based Glucose Meters.

Diabetes Technology & Therapeutics,

Vol10, No 2, 2008

AscorbateYesYesAccuChek Inform

Germagnolit L et al Suitability

Assessment of a New Bedside

Interference Free Glucose System for

Use in Critical Care when Compared to

Current Technology. Poster

presentation 22nd International AACC

CPOCT Barcelona 17-20 September

2008

AscorbateYesYesAccuChek Active

Britta F et al Analytical performance of

an interference-resistant glucose meter.

Poster presentation 22nd International

AACC CPOCT Barcelona 17-20

September 2008

AscorbateYesYesAccuChek Aviva

ReferenceOtherInterference

MaltoseInterference

HematocritInterference

Meter

Accuracy of Current meters continued

Thomas A et al An evaluation of the analytical

performance of a new generation hospital

based glucose meter and an assessment of

its clinical reliability in a neonatal careunit..Poster presentation 22nd International

AACC CPOCT Barcelona 17-20 September

2008

YesOptium Xceed

Karon BS et al. Evaluation of the Impact of

Hematocrit and Other Interference on the

Accuracy of Hospital-Based Glucose Meters.Diabetes Technology & Therapeutics, Vol10,

No 2, 2008

AscorbateYesPrecision PCx

Germagnolit L et al Suitability Assessment of

a New Bedside Interference Free GlucoseSystem for Use in Critical Care when

Compared to Current Technology. Poster

presentation 22nd International AACC CPOCT

Barcelona 17-20 September 2008

AscorbateYesPrecision Xtra

Britta F et al Analytical performance of an

interference-resistant glucose meter. Poster



Ascorbate andMaltose

YesPrecision Freestyle

ReferenceOther

Interference

Hematocrit

Interference

Meter

Accuracy of Current meters continued

Holtzinger C et al Evaluation of a New POCT Bedside

Glucose Meterand Strip With Hematocrit and

Interference Corrections Point of Care & Volume 7,Number 1, March 2008

AscorbateYesSureStepFlexx

Bewley B et al An evaluation of the analytical

specificity and clinical application of a new generation

hospital based glucose meter in a dialysis

setting..Poster presentation 22nd International AACC

CPOCT Barcelona 17-20 September 2008

YesAscensia Elite XL

Germagnolit L et al Suitability Assessment of a New

Bedside Interference Free Glucose System for Use in

Critical Care when Compared to Current Technology.

Poster presentation 22nd International AACC CPOCT


AscorbateYesAscensia Breeze 2

Britta F et al Analytical performance of an

interference-resistant glucose meter. Poster



AscorbateYesAscensia Contour

ReferenceOtherInterference

HematocritInterference

Meter

>5% chanceof

2-Step

Dosing Error

15%15%

16-45%10%10%

8-23%5%5%

InsulinInsulin

DosageDosage

Error RateError Rate

TotalTotal

AnalyticalAnalytical

Error (Error (cvcv%%

and bias)and bias)

Boyd, JD and Bruns, DE. Quality Specifications for Glucose Meters: Assessment by Simulation Modeling of Errors in Insulin Dose. Clinical Chemistry, 47:2, 209-214, 2001

Poor accuracy Leads To Insulin Dosing

Error

Average Percent Error for POC Glucose Meters Versus Reference Laboratory Value1

*Large errors of insulin dose (two-step or greater) occur >5% of the time whenaverage percent error of method exceeds 15%

1Mann EA et al. Error Rates Resulting from Anemia Can be Corrected in

Multiple Commonly Used Point of Care Glucometers. US Army Institute of

Surgical Research, 2008.

Safe and Effective Glycemic Management DemandsImproved Glucose Strip Performance

-11.4 to 59.018.7*108Precision PCx

-5.4 to 35.916.9*196Accu-ChekAdvantage

-3.9 to 37.116.0*187Accu-Chek Inform

-6.07 to 36.216.0*196SureStep Flexx

Error Range, min to max%

Average PercentErrorNMeter

US Army Institute of Surgical Research, 2008.

Average Percent Error for POC Glucose Meters Versus Reference Laboratory Value1

*Large errors of insulin dose (two-step or greater) occur >5% of the time whenaverage percent error of method exceeds 15%

1Mann EA et al. Error Rates Resulting from Anemia Can be Corrected in

Multiple Commonly Used Point of Care Glucometers. US Army Institute of

Surgical Research, 2008.

Safe and Effective Glycemic Management DemandsImproved Glucose Strip Performance

-11.4 to 59.022.3%Precision PCx

-5.4 to 35.917.1%Accu-Chek

Advantage

-3.9 to 37.115.4%Accu-Chek Inform

-6.07 to 36.220.6%SureStep Flexx

Error Range, min to max

%

Average Percent

Error @ Hct < 25%Meter

US Army Institute of Surgical Research, 2008.

• Mis-dosing of Insulin

• Failure to maintain safe and effective glycaemiccontrol

• Increased risk of hypoglycemia

• Increased hospital mortality

• Increased hospital morbidity

� Increased length of hospital stay

� Increased cost of patient care

Consequences of using Inaccurate Meters

StatStrip® GlucoseFirst Point-of-Care Whole Blood

Glucose Meter correcting forinterference

Op: 8636

13:42Meter Name: NICU-1

OK

Enter Patient ID

_________________________

Clear

1 2 3

4 5 6

7 8 9

ABC...0Scan

Accept

194546646

List

Gold film layer

� Electrochemical measuring surface

� Electrical contact to the meter

Micro-capillary vent layer

Micro-capillary sample channel layer

Electrode well layer

� Interference electrode well

� Reference electrode well

� Glucose, HCT electrode wells

Patent #6,287,451

StatStrip® Glucose Strip Design

Sample volume = 1.2 µL

Measurement time = 6 seconds

Novel strip technology provides basis

for;

• Measuring and correcting for hematocrit

• Correcting for assay interference factors

• Batch to batch production consistency – noneed for batch to batch calibration

• Robust and stable strips

Accuracy of StatStrip Glucose

NoneNoNoStatStrip Glucose

Other InterferencesMaltose

Interference

Hematocrit

Interference

Meter

References

• Germagnoli L et al Suitability Assessment of a New Bedside Interference Free Glucose System for Use inCritical Care when Compared to Current Technology. Poster presentation 22nd International AACC CPOCTBarcelona 17-20 September 2008

• Karon BS et al. Evaluation of the Impact of Haematocrit and Other Interference on the Accuracy of Hospital-Based Glucose Meters. Diabetes Technology & Therapeutics, Vol10, No 2, 2008

• Thomas A et al An evaluation of the analytical performance of a new generation hospital based glucosemeter and an assessment of its clinical reliability in a neonatal care unit..Poster presentation 22ndInternational AACC CPOCT Barcelona 17-20 September 2008

• Britta F et al Analytical performance of aninterference-resistant glucose meter. Poster presentation 22nd International AACC CPOCT Barcelona 17-20September 2008

• Bewley B et al An evaluation of the analytical specificity and clinical application of a new generation hospitalbased glucose meter in a dialysis setting..Poster presentation 22nd International AACC CPOCT Barcelona17-20 September 2008

• Holtzinger C et al Evaluation of a New POCT Bedside Glucose Meterand Strip With Haematocrit and Interference Corrections Point of Care & Volume 7, Number 1, March 2008

aaaaa

Assessment of Accuracy

ISO 15197 criteria

95% of glucose values should fall within 0.83 mmol/L ofreference values at a glucose concentration <4.2 mmol/Lor 20% of reference values at glucose concentration =4.2mmol/L.

TNO Quality guidelines

95% of glucose values should fall within 1.0 mmol/L ofreference values at a glucose concentration <6.5 mmol/Lor 15% of reference values at glucose concentration =6.5mmol/L. 95% of glucose values

Accuracy Assessment - NICU patients

StatStrip Bias comparison to ISO 15197 limits

-3

-2

-1

0

1

2

3

1 2 3 4 5 6 7 8 9 10 11 12

Reference mmol/LBia

s (

Sta

tStr

ip m

mo

l/L

min

us R

efe

ren

ce m

mo

l/L

)

Optium Xceed Bias comparison to ISO 15197 limits

-3

-2

-1

0

1

2

3

1 2 3 4 5 6 7 8 9 10 11 12

Reference mmol/L

Bia

s (

Op

tium

Xceed

mm

ol/L

min

us R

efe

rence m

mo

l/L)

Malic A et al Multiste evaluation of point of care glucoseEvaluation of the Impact of Hematocrit and OtherInterference on the Accuracy of meters in a neonatalintensive care unit. Poster presentation 23rd InternationalIntensive Care meeting Milan 18-19 October 2008 .

NICU patient study– Comparison with

TNO criteria

StatStrip Bias comparison to TNO Accuracy limits

-3

-2

-1

0

1

2

3

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

ABL 735 mmol/L

Bia

s (

Sta

tStr

ip m

mo

l/L

min

us A

BL

735 m

mo

l/L

)

Slingerland R et al The Nova Statstrip Blood GlucoseMeter Evaluation: Hematocrit Dependency, MethodComparison, Interfering Substances and NeonatalSamples. Poster presentation 22nd International AACCCPOCT Barcelona 17-20 September 2008

NICU patient study – Comparison withISO15197 criteria at low glucose range


≤ 4.2 mmol/L range

-3

-2

-1

0

1

2

3

1 2 3 4 5 6

Reference mmol/L

Bia

s (Sta

tStr

ip m

mol/L

min

us R

efe

rence

mm

ol/L)

Multi-site Study – UK, Holland, Canada


97.2 % concordancewith ISO 15197

criteria

NICU patient study – Assessment of

hematocrit influence at low glucose range

Multi-site Study – UK, Holland, Canada


StatStrip Glucose influence of hematocrit

-3

-2

-1

0

1

2

3

20 25 30 35 40 45 50 55 60 65 70 75 80

Hematocrit

Bia

s (Sta

tStr

ip m

mol/L

min

us R

efe

rence m

mol/l)

ICU patient study – Comparison with

ISO15197 criteria

Germagnoli L et al Suitability Assessment of a NewBedside Interference Free Glucose System for Use inCritical Care when Compared to Current Technology.Poster presentation 22nd International AACC CPOCTBarcelona 17-20 September 2008


-50

-40

-30

-20

-10

0

10

20

30

40

50

50 70 90 110 130 150 170 190

Cobas mg/dL

Bia

s (

Sta

tStr

ip m

g/d

L

min

us C

ob

as m

g/d

L)

Breeze 2 Bias comparison to ISO 15197 limits

-50

-40

-30

-20

-10

0

10

20

30

40

50

50 70 90 110 130 150 170 190

Cobas mg/dL

Bia

s (

Bre

eze 2

mg

/dL

min

us C

ob

as m

g/d

L)

Accuracy Assessment - ICU patients

Kanji's error gird for Statstrip Nova

-60

-40

-20

0

20

40

60

0 100 200 300 400 500 600Glycemia measured by hexokinase method mg/dL

Kanji's error gird for RapidLab 1265

-60

-10

40

0 100 200 300 400 500 600Glycemia measured by hexokinase method mg/dL

Roman A Comparison of accuracy of a glucometer and ablood gas analyser in an adult ICU:The StatStripNovaBiomedical fulfils TGC requirements.Poster presentation 22nd International AACC CPOCTBarcelona 17-20 September 2008

ICU patient study – Discrepancy

analysis compared to lab method

Point-of-care method number Bias ( mg/dL) SD number of > 10 %

discrepancies

number of > 20 %

discrepancies

RapidLab 1265 369 -3.1 10 25 ( 6,8% ) 1 (0,3% )

StatStrip Novabiomedical 369 -0.4 8 24 ( 6,5% ) 1 ( 0,3% )

Roman A Comparison of accuracy of a glucometer and ablood gas analyser in an adult ICU:The StatStripNovaBiomedical fulfils TGC requirements.Poster presentation 22nd International AACC CPOCTBarcelona 17-20 September 2008

Haematocrit - Dialysis patients

Bewley B et al An evaluation of theanalytical specificity and clinicalapplication of a new generation hospitalbased glucose meter in a dialysissetting..Poster presentation 22ndInternational AACC CPOCT Barcelona17-20 September 2008

StatStrip Glucose Influence of hematocrit

-3

-2

-1

0

1

2

3

30 35 40 45 50 55 60

Hematocrit (%)

Bia

s (

Sta

tStr

ip 2

mm

ol/

L

min

us

Re

fere

nc

e m

mo

l/l)

AccuChek Aviva Influence of hematocrit

-3

-2

-1

0

1

2

3

30 35 40 45 50 55 60

Hematocrit (%)

Bia

s (

Ro

ch

e 1

mm

ol/

L

min

us

Re

fere

nc

e m

mo

l/l)

Elite XL Influence of Hematocrit

-3

-2

-1

0

1

2

3

30 35 40 45 50 55 60

Hematocrit (%)

Bia

s (

Elite

XL

mm

ol/L

min

us R

efe

ren

ce m

mo

l/l)

Accuracy Assessment - Peritoneal

Dialysis patients


-3

-2

-1

0

1

2

3

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Dimension RxL mmol/L

Bia

s (

Sta

tStr

ip m

mo

l/L

min

us D

imen

sio

n m

mo

l/L

)

Elite XL Bias comparison to ISO 15197 limits

-3

-2

-1

0

1

2

3

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15


Bia

s (

Elite

mm

ol/L

min

us

Dim

en

sio

n m

mo

l/L

)

Aviva bias comparison to ISO 15197 limits

-3

-2

-1

0

1

2

3

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15


Bia

s (

Aviv

a m

mo

l/L

min

us

Dim

en

sio

n m

mo

l/L

)

Bewley B et al An evaluation of theanalytical specificity and clinicalapplication of a new generation hospitalbased glucose meter in a dialysissetting..Poster presentation 22ndInternational AACC CPOCT Barcelona17-20 September 2008

Dialysis patient study - Comparison against ISO15197 criteria

36

36

36

36

36

36

36

n

YesReference method

NoAccuChek Aviva lot 2

NoAccuChek Aviva lot 1

NoAscencia Elite XL lot 2

NoAscencia Elite XL lot 1

YesStatStrip lot 2

YesStatStrip lot 1

Meeting ISO 15197

criteria

Glucose Meter

Bewley B et al An evaluation of the analytical specificity and clinicalapplication of a new generation hospital based glucose meter in a dialysissetting..Poster presentation 22nd International AACC CPOCT Barcelona 17-20 September 2008

StatStrip® Glucose’ multi-well technologyaddresses the requirements for improvedaccuracy and precision

� Clinical accuracy validated in >20 studiesworldwide

� Good accuracy for measuring glucose in allhospital settings including NICU, ICU, dialysis

� Elimination of glucose reading errors due tohaematocrit and other common interferingsubstances

� No calibration codes required

Summary

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