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
presentation 22nd International AACC CPOCT
Barcelona 17-20 September 2008
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
Barcelona 17-20 September 2008
AscorbateYesAscensia Breeze 2
Britta F et al Analytical performance of an
interference-resistant glucose meter. Poster
presentation 22nd International AACC CPOCT
Barcelona 17-20 September 2008
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
StatStrip Bias comparison to ISO 15197 limits
≤ 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
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 .
97.2 % concordancewith ISO 15197
criteria
NICU patient study – Assessment of
hematocrit influence at low glucose range
Multi-site Study – UK, Holland, Canada
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 .
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
StatStrip 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 (
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
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 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
Dimension RxL mmol/L
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
Dimension RxL mmol/L
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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