CLINICAL STUDIES

Evaluation of Abbott Diabetes Care FreeStyle Precision Pro

Point-of-Care Blood Glucose Monitoring System

Objectives: To evaluate the performance of the Abbott Diabetes Care FreeStyle Precision Pro Blood Glucose
Monitoring System with capillary, arterial, venous and neonatal blood samples in clinical and laboratory
studies.

Methods: Accuracy and user performance in testing capillary blood samples were assessed at two diabetes
clinics. Results obtained with three lots of test strips were compared to plasma equivalent glucose
values from the YSI analyser.

Accuracy in testing arterial, venous and neonatal blood samples were each evaluated at a different
clinical or medical centres. Results obtained with three lots of test strips were compared to those from
the YSI and/or a laboratory plasma analyser.

Laboratory studies were performed at Abbott Diabetes Care to verify the performance of the FreeStyle
Precision Pro system under varied test conditions.

Results: The clinical accuracy of the FreeStyle Precision Pro system was evaluated by comparing 163 capillary
glucose results from 143 subjects using 3 lots of test strips with results obtained from the YSI analyser.
Ninety-nine percent of the FreeStyle Precision Pro results agreed within ± 15 mg/dL (0.83 mmol/L)
of the YSI values at glucose concentrations < 100 mg/dL (5.55 mmol/L) and within ± 15% at glucose
concentrations ≥ 100 mg/dl (5.55 mmol/L). The studies with arterial, venous and neonatal blood
samples also demonstrated good agreement between the FreeStyle Precision Pro system and the YSI
and laboratory analysers.

In the laboratory repeatability study, the coefficients of variation (CV) ranged from 2.9 to 3.2% at
glucose levels ≥ 100 mg/dL (5.55 mmol/L). At glucose levels < 100 mg/dL (5.55 mmol/L), the standard
deviations (SD) ranged from 2.2 mg/dL (0.12 mmol/L) to 3.3 mg/dL (0.18 mmol/L). The FreeStyle
Precision Pro system produced accurate results across a broad haematocrit range (15 – 65%) and a
glucose measurement range of 20 to 500 mg/dL (1.1 to 27.8 mmol/L). Additional studies showed that
no clinically significant effect on the accuracy of the FreeStyle Precision Pro system was observed
with wide ranges of oxygen partial pressures and common drugs or endogenous substances at high
concentrations. In the user performance survey for the FreeStyle Precision Pro system, the overall
mean rating by 150 first-time users was 5.5 (on a 1 to 6 scale, with 6 being the highest rating), indicating
that lay users found the FreeStyle Precision Pro system easy to use.

Conclusions: These studies verify the clinical accuracy of the FreeStyle Precision Pro system for capillary, arterial,
venous and neonatal samples when compared to laboratory method results – accuracy of the system
with all blood sample types meets more stringent accuracy criteria than have previously been used to
evaluate POC systems. The FreeStyle Precision Pro system also had a high acceptance rating by first
time users. Laboratory studies demonstrated that the current system maintained accuracy in various
challenging conditions that may be encountered in everyday testing.
Introduction Figure 2. FreeStyle Precision Pro Measurement Principal

The FreeStyle Precision Pro Blood Glucose Monitoring System

(BGMS), based on TrueMeasure test strip technology, has
been developed to meet tighter accuracy criteria when used
with capillary, arterial, venous, and neonatal blood samples.
The FreeStyle Precision Pro system is designed to simplify
point of care testing (POCT) for healthcare professionals,
providing features that enhance the reliability of the testing
process and support compliance with POCT policies. The test
strip, also branded as FreeStyle Precision Pro, can only be
used in the Freestyle Precision Pro meter. The test strips retain
the TrueMeasure features of previous Abbott Diabetes Care
Point of Care products (dual fill [end fill or top fill], fill trigger
electrode and unique chemistry with low applied potential), the
small sample volume requirement (minimum sample volume
is 0.6 µL) and the individual foil wrapping to protect from Dual Fill
exposure to moisture or chemicals and cross-contamination The test strip retains the dual-fill feature that allows the user to
by bacteria. In addition, the FreeStyle Precision Pro system apply blood to either the top or the end of the test strip (Figure
has improved accuracy and reduced sensitivity to haematocrit 3). The blood is automatically drawn into the reaction area.
(to maintain compliance with more stringent accuracy criteria
which are discussed in more detail elsewhere1,2,3), a 5 second Figure 3. End fill or Top Fill Test Strip
test time, real time wireless data transmission (WiFi) capability
and a 2D barcode reader.

Technology
Measurement Principal
Glucose dehydrogenase (GDH-NAD), coenzyme nicotinamide
adenine dinucleotide (NAD) and an electron mediator
(phenanthroline quinone, PQ) are present on the working
electrode of the test strip. Glucose in the blood sample
is oxidised to gluconolactone by reaction with NAD, this
oxidation is catalysed by GDH (Figure 1). The PQ reacts with
the reduced coenzyme (NADH), thus reducing the mediator
and returning the coenzyme to its oxidised state (NAD). The
reduced mediator is oxidised at the working electrode, this
produces a small electric current which is proportional to the
concentration of glucose in the sample and is measured by
the meter.
Fill Trigger Electrode
The test strip contains three electrodes (working, reference
and fill trigger) – see Figure 4. The circuit between the fill
trigger and the reference electrodes must be detected by the
meter before the test will start. The completed circuit is only
detected when the applied sample flows beyond the reference
and working electrodes to contact the fill trigger electrode
(Figure 5). This feature minimizes errors due to insufficient
sampling and reduces test strip waste. Upon application of
sufficient sample, the test is automatically initiated.

Figure 1. Reaction Scheme

Lack of Interference
GDH can be used to perform electrochemical glucose
measurements without direct interference by oxygen in the
blood sample, thus reducing interfering effects caused by
oxygen. A commonly used enzyme in other BGMS, Glucose
Oxidase (GOX), may react with oxygen to cause measurement
errors.

Low potential measurements (Figure 2) can minimize

interference by substances present in the blood sample. For
an electrochemical reaction to occur, a potential (voltage)
is applied between the working and reference electrode.
The larger the applied potential, the greater the number of
interfering substances that can be oxidized at the working
electrode and produce a false signal. The electron mediator
(PQ) used in these test strips allows the electrochemical
reaction to occur at low potential, so that very few substances
interfere with the test strip results.

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 Figure 4. Test Strip Architecture

Figure 5. Test Strip Only Starts When Sufficient Sample
is Applied Completed circuit only detected when sample
reaches the trigger electrode

Summary of Features
The combination of the fill trigger electrode, the GDH-
NAD chemistry with low applied electric potential and the
dual fill design with visual confirmation of fill is the basis of
TrueMeasure technology, designed to minimize errors from
insufficient blood samples and interfering substances, allow
easy sample application and thus protect the integrity of
glucose testing data from preventable errors. Test strips are
wrapped individually in foil packets to protect from exposure
to moisture or chemicals and cross-contamination by bacteria.

In addition to the features described above, the FreeStyle

 P
Precision Pro system incorporates a number of enhancements
to provide reduced sensitivity to haematocrit and improved

 accuracy with a shorter (5 s) test time for glucose testing, thus

ensuring compliance to more stringent accuracy criteria, and
also to enhance reliability of the testing process and support
compliance to POCT policies:

• More measurements* made during the glucose test

to enhance accuracy
• Automatic compensation (in glucose measurement)
for haematocrit from 15% to 65%
• Dual band WiFi capability
• 2D barcode reader
(* Versus the Precision Xceed Pro system)

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Performance Evaluation In accordance with ISO 151972 and CLSI guideline
POCT12-A3,3 blood samples collected with an appropriate
This report details a comprehensive evaluation of the FreeStyle anticoagulant were spiked with a 0.9% saline solution
Precision Pro Blood Glucose Monitoring System. Multicenter containing a high concentration of glucose to prepare high
clinical studies were conducted to evaluate performance with glucose samples; the spiked samples were allowed to stand
various samples types. Additional laboratory studies were for at least 15 minutes before use to allow the added glucose
performed to validate performance claims under various to equilibrate between the plasma and red blood cells. To
testing conditions. prepare low glucose samples, blood samples collected with
an appropriate anticoagulant were incubated at 37 °C to allow
glycolysis to occur.
Comparative Methods
The YSI 2300 Stat Plus glucose analyzer served as the
comparative method in the capillary, venous and arterial Results
clinical studies and in the laboratory studies. The YSI whole The haematocrit range of the capillary samples in this study
blood glucose results were multiplied by 1.12 to obtain plasma was 22 – 53%, and the range of glucose concentrations was
equivalent glucose values for comparison with the test strip 33 – 494 mg/dL (1.8 – 27.4 mmol/L). Results are tabulated in
results. The YSI glucose analyzer has metrological traceability Appendix Table 7.
to CDC hexokinase method and NIST certified reference
material.4 Excellent correlation was found between the FreeStyle
Precision Pro system and the YSI analyser by regression
Laboratory plasma reference analysers were also used as analysis (r = 0.99, slope = 1.0, intercept = -2.5 mg/dL
comparative methods in the venous (YSI Plasma), neonatal [-0.14 mmol/L]) – see Figure 6. Overall the mean absolute
(Roche Cobas 6000) and arterial (Beckman DxC 800) studies. relative difference (MARD) was 5.0% and the mean CV
between the paired tests for the 163 samples was 3.3%. Of
the 973 test results, 972 (99.9%) were in Zone A (clinically
Statistical Analysis
accurate) and 1 (0.1%) was in Zone B (clinically acceptable) of
All statistical analyses for the clinical studies were performed
the Consensus Error Grid7 – see Figure 6.
using SAS® ver 9.2 or higher (SAS Institute Inc., Cary, NC).
Passing–Bablok regression analysis5 was used to correlate
meter results with comparative method values in capillary, Figure 6. Accuracy with Capillary Blood –
arterial and venous clinical evaluations. Passing–Bablok Consensus Error Grid & Regression Analysis
regression analysis is recommended by the American
Association of Bioanalysts6 for method comparison (accuracy)
studies. Standard linear regression was used to correlate
meter results with comparative method values in the neonatal
clinic (due to the low glucose concentrations of the samples).
Mean absolute relative difference (MARD) between meter
results and comparative method values was calculated with
all results of each sample type to assess the mean absolute
bias. Data were excluded from statistical analysis if (1) the
drift between the first and second measurements of the
comparative method was >4 mg/dL (0.2 mmol/L) at glucose
≤100 mg/dL (5.55 mmol/L) or >4% at glucose >100 mg/dL
(5.55 mmol/L), (2) test time exceeded the interval specified
in the protocol, or (3) the data set was not complete. The
incidence of data exclusion in the accuracy studies was under
1.0%. Laboratory study results were evaluated using JMP ver
5.1 statistical software (SAS Institute).

Clinical Studies
The following clinical studies were conducted at various
diabetes clinics and medical centers in the United States.
Results of the capillary, venous and arterial studies were System accuracy analysis of results for the 3 lots combined
reported previously in a peer reviewed journal, they are showed 99.3% of results agreed within 15 mg/dL (0.83
included here for completeness.1 mmol/L) or 15% (at glucose concentrations ≥ 100 mg/dL
[5.55 mmol/L]) of the reference value (see Figure 7). These
results, in combination with the results above confirming
Capillary Study that 100% of test strip results are within Zones A & B of the
Consensus Error Grid, illustrate that the FreeStyle Precision
Materials & Method Pro system meets the accuracy criteria in ISO 15197:2013.2
Accuracy of the FreeStyle Precision Pro system was evaluated
at two centers. 150 subjects were enrolled in the study,
testing was completed on 163 samples from 143 subjects.
Each sample was tested in duplicate on three test strip lots,
yielding 973 results in total, which were compared to results
obtained on the YSI analyzer. Twenty samples were modified
to provide additional samples with low and high glucose
concentrations: 5 samples ≤ 50 mg/dL (2.8 mmol/L), 7 samples
51 – 80 mg/dL (2.8 – 4.4 mmol/L), 2 samples 301 – 400 mg/dL
(16.7 – 22.2 mmol/L), 6 samples > 400 mg/dL (22.2 mmol/L).
4 of 18
Analysis of the results against the accuracy criteria described
in CLSI guideline POCT12-A3 was also performed, results for
the 3 lots combined showed:
• 97.3% of results agreed within 12 mg/dL
(0.67 mmol/L) or 12.5% (at glucose concentrations
≥ 100 mg/dL [5.55 mmol/L]) of the reference value
• 99.9% of results agreed within 15 mg/dL
(0.83 mmol/L) or 20% (at glucose concentrations ≥
75 mg/dL [4.2 mmol/L]) of the reference value
Collectively these results illustrate that the FreeStyle Precision
Pro system meets the accuracy criteria in CLSI guideline
POCT12-A3.3
Figure 7. Accuracy with Capillary Blood –
System Accuracy Analysis
Capillary Blood – Haematocrit Sensitivity
The effect of haematocrit on the test result was assessed
using regression analysis to correlate the percentage bias
(i.e. difference between test strip result and the reference
value) with haematocrit level (for the non-modified samples
only – haematocrit range 22-50% and glucose range 53-489
mg/dL [2.9-27.2 mmol/L]): slope = 0.08 %bias/%haematocrit,
intercept = -3.7 %bias, n = 856 – see Figure 8. Biases at
various haematocrit levels were then calculated based on the
regression statistics. Relative to a control condition of 45%
haematocrit (mid point of normal range), test strip results
decreased 2.4% as haematocrit reached 15% and increased
1.6% as haematocrit reached 65% – see Table 1. The low
slope and small changes in bias at the extreme haematocrit
levels confirm that the FreeStyle Precision Pro system has
little sensitivity to haematocrit.
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Figure 8. Capillary Blood – Haematocrit Sensitivity
Table 1. Capillary Blood – Haematocrit Sensitivity
Capillary Blood Haematocrit % % Bias from 45% Haematocrit
15 -2.4
30 -1.2
55 0.8
65 1.6
Arterial Study
Materials & Method
Accuracy of the FreeStyle Precision Pro system was evaluated
using left over arterial blood samples from the blood gas
laboratory that serves mainly intensive care unit and operating
room patients at a medical center. 120 blood samples were
tested on three test strip lots, yielding 360 results in total,
which were compared to results obtained on the YSI analyser.
In addition, test strip results were compared to a Beckman
DxC 800 laboratory analyzer (after centrifugation of the blood
samples to obtain the plasma fraction), as laboratory plasma
analysers are typically used within a hospital setting.
Results
The haematocrit range of the arterial samples in this study
was 21 – 50%, the range of glucose concentrations was
66 – 236 mg/dL (3.7 – 13.1 mmol/L) and the partial pressure of
oxygen ranged from 4.8 – 35.7 kPa (36 – 268 mm Hg). Results
are tabulated in Appendix Table 7.
Excellent correlation was found between the FreeStyle
Precision Pro system and the YSI analyser by regression
analysis (r = 0.98, slope = 1.08, intercept = -9.2 mg/dL
[-0.51 mmol/L]) – see Figure 9A. Overall the mean absolute
relative difference (MARD) was 3.9%. Of the 360 test results,
359 (99.7%) were in Zone A (clinically accurate) and 1 (0.3%)
was in Zone B (clinically acceptable) of the Consensus Error
Grid7 – see Figure 9A.
Excellent correlation was also found between the FreeStyle
Precision Pro system and the Beckman DxC 800 analyser
by regression analysis (r = 0.98, slope = 1.07, intercept =
-9.5 mg/dL [-0.53 mmol/L]) – see Figure 9B. Overall the mean
absolute relative difference (MARD) was 4.3%. Of the 360 test
results, 359 (99.7%) were in Zone A (clinically accurate) and 1
(0.3%) was in Zone B (clinically acceptable) of the Consensus
Error Grid7 – see Figure 9B.
Figure 9. Accuracy with Arterial Blood –
Consensus Error Grid & Regression Analysis
A – YSI
B – Beckman DxC 800
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System accuracy analysis of results for the 3 lots combined
showed:
• 99.4% of results agreed within 15 mg/dL
(0.83 mmol/L) or 15% (at glucose concentrations
≥ 100 mg/dL [5.55 mmol/L]) of the YSI reference
values (see Figure 10A)
• 99.7% of results agreed within 15 mg/dL
(0.83 mmol/L) or 15% (at glucose concentrations
≥ 100 mg/dL [5.55 mmol/L]) of the Beckman DxC
800 reference values (see Figure 10B)
These results, in combination with the results above confirming
that 100% of test strip results are within Zones A & B of the
Consensus Error Grid, illustrate that the FreeStyle Precision
Pro system meets the accuracy criteria in ISO15197:2013.2
Analysis of the results against the accuracy criteria described
in CLSI guideline POCT12-A3 was also performed. Results,
compared to the YSI analyser, for the 3 lots combined showed:
• 98.9% of results agreed within 12 mg/dL
(0.67 mmol/L) or 12.5% (at glucose concentrations
≥ 100 mg/dL [5.55 mmol/L]) of the YSI reference
values
• 100% of results agreed within 15 mg/dL
(0.83 mmol/L) or 20% (at glucose concentrations
≥ 75 mg/dL [4.2 mmol/L]) of the YSI reference
values.
Results, compared to a Beckman DxC 800 analyser, for the 3
lots combined showed:
• 97.8% of results agreed within 12 mg/dL
(0.67 mmol/L) or 12.5% (at glucose concentrations
≥ 100 mg/dL [5.55 mmol/L]) of the Beckman DxC
800 reference values
• 100% of results agreed within 15 mg/dL
(0.83 mmol/L) or 20% (at glucose concentrations
≥ 75 mg/dL [4.2 mmol/L]) of the Beckman DxC
800 reference values
Collectively these results illustrate that the FreeStyle Precision
Pro system meets the accuracy criteria in CLSI guideline
POCT12-A3.3
 Figure 10. Accuracy with Arterial Blood – System
Accuracy Analysis
A – YSI
B – Beckman DxC 800
Arterial Blood – Oxygen Sensitivity
The effect of oxygen on the test result was assessed
using regression analysis to correlate the percentage bias
(i.e. difference between test strip result and the reference value)
with oxygen level: slope = -0.28 %/kPa (-0.037 %/mm Hg),
intercept = 5% and r = -0.38 – see Figure 11. Biases at various
oxygen levels were then calculated based on the regression
statistics. Relative to pO2 of 12 kPa (90 mmHg; partial pressure
of oxygen in capillary blood), test strip results increased 1.4%
as pO2 dropped to 5 kPa (38 mm Hg) and decreased 2.2% as
pO2 increased to 20 kPa (150 mm Hg) – see Table 2. Test strip
results decreased 6.4% (relative to 12 kPa) as pO2 increased
to 35 kPa (263 mm Hg), however, pO2 greater than 20 kPa
(150 mm Hg) are only found in patients receiving oxygen
therapy.8 These magnitudes of changes associated with
extreme levels of oxygen are clinically acceptable.
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Figure 11. Arterial Blood – Oxygen Sensitivity
Table 2. Arterial Blood – Oxygen Sensitivity
pO2 / kPa (mm Hg) % Bias from 12 kPa (90 mm Hg)
5 (38) 1.4
12 (90) 0
20 (150) -2.2
35 (263) -6.4
Venous Study
Materials & Method
Accuracy of the FreeStyle Precision Pro system was
evaluated at one center. 126 subjects were enrolled in the
study, testing and analysis was completed on samples from
110 subjects. Each subject provided two tubes of venous
blood (one anticoagulated with heparin and one with ETDA).
The 220 samples were tested in duplicate on three test strip
lots, yielding 1320 results in total, which were compared
with results obtained on the YSI analyser (plasma equivalent
values). In addition, test strip results were compared to YSI
plasma values (after centrifugation of the blood samples to
obtain the plasma fraction), as laboratory plasma analysers
are typically used within a hospital setting.
Results
The haematocrit range of the venous samples in this study
was 27 – 52%, and the range of glucose concentrations was
57 – 372 mg/dL (3.2 – 20.6 mmol/L). Results are tabulated in
Appendix Table 7.
Excellent correlation was found between the FreeStyle
Precision Pro system and the YSI analyser (plasma equivalent
values) by regression analysis for both heparin and EDTA
anticoagulated samples (heparin: r = 0.99, slope = 1.00,
intercept = 4.3 mg/dL [0.2 mmol/L]; EDTA: r = 0.99, slope =
0.98, intercept = 5.4 mg/dL [0.3 mmol/L]) – see Figure 12.
Overall the mean absolute relative difference (MARD) was
4.4% & 4.2% for heparin & EDTA samples, respectively and
the mean CV between the paired tests for the 220 samples
was 2.3% & 2.2% for heparin & EDTA, respectively. Of the 660
test results compared against YSI plasma equivalent values
for both heparin and EDTA anticoagulated samples, 660
(100%) were in Zone A (clinically accurate) of the Consensus
Error Grid - see Figure 12.
 Figure 12. Accuracy with Venous Blood – Consensus
Error Grid & Regression Analysis
A – EDTA, YSI Plasma Equivalent
B – Heparin, YSI Plasma Equivalent
Excellent correlation was also found between the FreeStyle
Precision Pro system and the YSI plasma results by regression
analysis for both heparin and EDTA anticoagulated samples
(heparin: r = 0.99, slope = 1.00, intercept = 4.6 mg/dL
[0.3 mmol/L]; EDTA: r = 0.99, slope = 0.98, intercept =
6.0 mg/dL [0.3 mmol/L]) – see Figure 13. Overall the mean
absolute relative difference (MARD) was 4.8% & 4.4% for
heparin & EDTA samples, respectively and the mean CV
between the paired tests for the 220 samples was 2.3% &
2.2% for heparin & EDTA, respectively. Of the 660 test results
compared against YSI plasma values for both heparin and
EDTA anticoagulated samples, 660 (100%) were in Zone A
(clinically accurate) of the Consensus Error Grid - see Figure 13.
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Figure 13. Accuracy with Venous Blood –
Consensus Error Grid & Regression Analysis
A – EDTA, YSI Plasma
B – Heparin, YSI Plasma
System accuracy analysis of results for the 3 lots combined
(for heparin and EDTA anticoagulated samples) showed:
• ≥ 99.7% of results agreed within 15 mg/dL
(0.83 mmol/L) or 15% (at glucose concentrations
≥ 100 mg/dL [5.55 mmol/L]) of the YSI plasma
equivalent reference values (see Figure 14)
• 99.2% of results agreed within 15 mg/dL
(0.83 mmol/L) or 15% (at glucose concentrations
≥ 100 mg/dL [5.55 mmol/L]) of the YSI plasma
reference values (see Figure 15)
These results, in combination with the results above confirming
that 100% of test strip results are within Zones A & B of the
Consensus Error Grid, illustrate that the FreeStyle Precision
Pro system meets the accuracy criteria in ISO15197:2013.2
Figure 14. Accuracy with Venous Blood – System Figure 15. Accuracy with Venous Blood – System
Accuracy Analysis Accuracy Analysis

A – EDTA, YSI Plasma Equivalent A – EDTA, YSI Plasma

B – Heparin, YSI Plasma Equivalent B – Heparin, YSI Plasma

Analysis of the results against the accuracy criteria described

in CLSI guideline POCT12-A3 was also performed. Results,
compared to YSI plasma equivalent values, for the 3 lots
combined showed:

• ≥ 97.3% of results agreed within 12 mg/dL

(0.67 mmol/L) or 12.5% (at glucose concentrations
≥ 100 mg/dL [5.55 mmol/L]) of the YSI plasma
equivalent reference values
• ≥ 99.8% of results agreed within 15 mg/dL
(0.83 mmol/L) or 20% (at glucose concentrations
≥ 75 mg/dL [4.2 mmol/L]) of the YSI plasma
equivalent reference values.
Results, compared to YSI plasma results, for the 3 lots
combined showed:

• ≥ 96.4% of results agreed within 12 mg/dL

(0.67 mmol/L) or 12.5% (at glucose concentrations
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 ≥ 100 mg/dL [5.55 mmol/L]) of the YSI plasma
reference values
• ≥ 99.8% of results agreed within 15 mg/dL
(0.83 mmol/L) or 20% (at glucose concentrations
≥ 75 mg/dL [4.2 mmol/L]) of the YSI plasma
reference values
Collectively these results illustrate that the FreeStyle Precision
Pro system meets the accuracy criteria in CLSI guideline
POCT12-A3.3
System accuracy analysis of results for the 3 lots
combined showed 100% of results agreed within 15 mg/dL
(0.83 mmol/L) or 15% (at glucose concentrations ≥ 100 mg/dL
[5.55 mmol/L]) of the reference value (see Figure 17). These
results, in combination with those above confirming that 100%
of test strip results are within Zones A & B of the Consensus
Error Grid, illustrate that the FreeStyle Precision Pro system
meets the accuracy criteria in ISO 15197:2013.2
Analysis of the results against the accuracy criteria described
in CLSI guideline POCT12-A3 was also performed, results for

Neonatal Study the 3 lots combined showed:

Materials & Method • 99% of results agreed within 12 mg/dL

Accuracy of the FreeStyle Precision Pro system was evaluated (0.67 mmol/L) or 12.5% (at glucose concentrations
using 3 test strip lots and 127 left over neonatal blood samples ≥ 100 mg/dL [5.55 mmol/L]) of the reference value
(heelstick, subjects ranged from 1 to 30 days old) at a medical • 100% of results agreed within 15 mg/dL
center. Testing and analysis was completed on samples from (0.83 mmol/L) or 20% (at glucose concentrations
118 subjects. The 118 samples were tested in duplicate on ≥ 75 mg/dL [4.2 mmol/L]) of the reference value
two test strip lots (the 3 lots were rotated through the study),
Collectively these results illustrate that the FreeStyle Precision
yielding 471 results in total, which were compared to results
Pro system meets the accuracy criteria in CLSI guideline
obtained on the Roche Cobas 6000 laboratory analyzer (after
POCT12-A3.3
centrifugation of the blood samples to obtain the plasma
fraction).
Figure 17. Accuracy with Neonatal Blood – System
Accuracy Analysis
Results
The haematocrit range of the samples in this study was
22 – 61%, and the range of glucose concentrations was
31 – 142 mg/dL (1.7 -7.9 mmol/L).

Excellent correlation was found between the FreeStyle

Precision Pro system and the Roche Cobas 6000 laboratory
analyser by regression analysis (r = 0.98, slope = 1.03, intercept
= -4.6 mg/dL [-0.26 mmol/L]) – see Figure 16. Overall the
mean absolute relative difference (MARD) was 5.8% and the
mean CV between the paired tests for each sample was 2.8%.
Of the 471 test results, 457 (97%) were in Zone A (clinically
accurate) and 14 (3%) were in Zone B (clinically acceptable)
of the Leroux Error Grid9 - see Figure 16. Consensus Error
Grid analysis was also performed. Of the 471 test results, 471
(100%) were in Zone A (clinically accurate) of the Consensus
Error Grid.

Figure 16. Accuracy with Neonatal Blood –

Leroux Error Grid & Regression Analysis

Ease of Use Testing

Materials & Method
A total of 150 lay users at 2 diabetes clinics participated in
the user performance evaluation. Each lay user completed
a test on each test strip lot prior to the trained operator
testing reported in the capillary study above. The ages of the
subjects ranged from 36 to 76 years. Fifty three percent of the
subjects were male and 47% were female. Their education
levels spanned from junior high school to graduate degrees.
Thirty-three percent had Type 1 diabetes and 61% had Type 2
diabetes. After reading the instructions for use and performing
a glucose test on their own, the lay users in this study were
asked to complete a questionnaire rating ease-of-use topics.
A scale of 1 to 6 was used, with 6 being the highest rating.
An overall ease-of use rating was obtained by averaging all
responses.

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Results Table 4. Effect of Haematocrit
An overall ease of use rating of 5.5 (out of 6) was obtained
when all responses were averaged, indicating that the lay Mean bias difference from control
Glucose (42% haematocrit)
users found the FreeStyle Precision Pro system easy to use
concentration,
– see Table 3.
mg/dL (mmol/L) 15% 20% 30% 50% 60% 65%

Table 3. Ease of Use Rating of the 40-50

1.9* 0.0* 1.6* 1.2* -3.7* -0.1*
FreeStyle Precision Pro System (2.2-2.8)
100-120
Mean 1.0 -0.9 4.1 -1.7 -1.3 2.8
Statement (5.6-6.7)
Rating*
210-230
The test instructions contain sufficient information for me 2.5 0.2 2.3 -3.3 -2.5 -1.9
5.5 (11.7-12.8)
to do a test
330-350
The test instructions are easy to follow 5.5 1.5 1.5 2.9 0.0 -4.1 -2.4
(18.3-19.4)
The meter was easy to learn 5.5 440-460
0.8 0.3 1.3 0.2 -3.5 2.0
(24.4-25.5)
It was easy to scan/enter the test strip into the meter 5.2 Mean bias, mg/dL (mmol/L), at glucose
<100 mg/dL (5.55 mmol/L)
The meter is easy to use 5.4

It was easy to insert the test strip into the meter 5.5 1.9 0.0 1.6 1.2 -3.7 -0.1
(0.1) (0.0) (0.1) (0.1) (-0.2) (0.0)
The test strip is easy to use 5.3
Mean bias, %, at glucose ≥ 100 mg/dL
(5.55mmol/L)
It was easy to read the meter display 5.8
The prompts (or instructions) on the meter display were 1.5 0.3 2.7 -1.2 -2.9 -0.9
5.7
easy to follow
* Bias values are in mg/dL at glucose concentrations < 100 mg/dL
Mean over all statements 5.5 (5.55 mmol/L)

* The rating scale is 1 to 6 for each statement; 6 is strongly agree and 1 is

strongly disagree.
Precision (Repeatability
and Intermediate)
Laboratory Studies
Materials & Method
The following studies were performed at Abbott Diabetes Repeatability was evaluated using 10 meters, 3 test strip lots,
Care. and 5 venous blood samples with glucose concentrations
adjusted to represent hyperglycaemic, euglycaemic and

Haematocrit Studies hypoglycaemic conditions and matching the five concentration

Materials & Method
The effect of haematocrit on the performance of the FreeStyle
Precision Pro system was evaluated using seven haematocrit
levels, five glucose concentrations and three test strip lots.
The venous blood sample was adjusted to the 5 glucose
concentrations and 7 haematocrit levels (15, 20, 30, 42
[control sample], 50, 60 & 65%) by separating the plasma
from the cells, then adding aliquots of plasma to packed cells
in different proportions, as described in ISO 15197.2 30 tests
were performed for each of the 35 samples. Each sample was
also tested on the YSI 2300 Stat Plus glucose analyzer and
the results were used to calculate biases of the meter results.
To determine haematocrit effects, the difference between the
average glucose bias (from reference value) and the average
bias (from reference value) of the haematocrit control sample
(42 % haematocrit) was calculated for each sample.
ranges specified in ISO 15197.2 10 measurements were made
with each combination of meter, test strip lot and sample.
Testing was completed in 1 day.
Intermediate precision was evaluated using 10 meters,
3 test strip lots and 3 levels of control solution, representing
hyperglycaemic, euglycaemic and hypoglycaemic conditions.
Each sample was tested in duplicate on 3 test strip lots and 10
meters on each of 20 days.
Results
Repeatability: Precision was pooled for 30 tests across
3 test strip lots using fresh venous blood (at each of 5
glucose concentrations) – see Table 5. The pooled SD was
<3.5 mg/dL (0.19 mmol/L) at glucose concentrations
<100 mg/dL (5.55 mmol/L) and the pooled CV was <3.5% at
glucose concentrations ≥100 mg/dL (5.55 mmol/L).

Results Intermediate: Precision was pooled for 1200 tests across

For each test strip lot, the average difference in bias between 3 test strip lots performed over 20 days (at each of 3
test samples and control samples were less than the criteria glucose concentrations) – see Table 5. The pooled SD was
outlined in ISO 15197,2 therefore results for each test strip <5 mg/dL (0.28 mmol/L) at glucose concentrations
lot have been combined for presentation here (in line with <100 mg/dL (5.55 mmol/L) and the pooled CV was <4% at
the guidance in ISO 15197:2013) – see Table 4. Differences glucose concentrations ≥100 mg/dL (5.55 mmol/L).
in the haematocrit level of the blood sample affect results by
≤3.7 mg/dL (0.2 mmol/L) at low glucose concentrations and
by ≤4.1% at higher glucose concentrations – these were less
than the criteria in ISO 15197:2013, which trigger inclusion of
the results in the product labelling.
11 of 18
 Table 5. Precision
Interference Studies
Repeatability Intermediate Precision
(Spiked Venous Samples) (Control Solution)
Materials & Method
Thirty-six substances (including reducing substances,
Mean Mean common medications and non-glucose sugars) were tested
Pooled
test strip Pooled SD, test strip
Pooled SD, Pooled for interference in accordance with ISO 15197,2 with venous
result, mg/dL result,
CV % mg/dL CV % blood in two glucose concentration ranges (50-100 mg/dL
mg/dL (mmol/L) mg/dL
(mmol/L) [2.78-5.55 mmol/L] and 250-350 mg/dL [13.88-19.43 mmol/L])
(mmol/L) (mmol/L)
and three test strip lots, using a paired-sample experimental
44.3 2.8
45.7 (2.5) 2.2 (0.12) - - design. Thirty tests were made per sample. The YSI 2300
(2.5) (0.16)
Stat Plus glucose analyzer was used to assign glucose
96.3 4.9 reference values to the samples. For each sample, the bias
91.1 (5.1) 3.3 (0.18) - -
(5.3) (0.27) of the average measured values (test strip results) from the
139 YSI reference value was determined. The difference in bias
- 3.2
(7.7) between test sample and control sample was then calculated
220.8 for each substance.
- 2.9
(12.3)
364.1 310.3 Three of the substances (ascorbate, glutathione and
- 2.9 xylose) were further evaluated for interference using venous
(20.7) (17.2) - 3.8
blood in two glucose concentration ranges (50-100 mg/dL
[2.78-5.55 mmol/L] and 250-350 mg/dL [13.88-19.43 mmol/L]),
three test strip lots and a dose response experimental design.
Linearity For each glucose concentration, the sample was divided
into 5 aliquots, 4 tests samples and 1 control sample. The
Materials & Method test samples were then spiked with different concentrations
Linearity was assessed with three lots of test strips. With of the substance. Thirty tests were made per sample. The
each lot, testing was conducted using 3 venous whole blood YSI analyser was used to assign glucose reference values to
samples, spiked to various glucose concentrations. 30 tests the samples. Regression analysis was used to calculate the
were performed across 3 test strip lots with each sample/ interfering dose concentrations – the concentration where the
concentration, which were also tested in duplicate on a YSI bias to control is 10 mg/dL (0.55 mmol/L).
analyser.

Results
Linearity was demonstrated across the measurement range of
20 – 500 mg/dL (1.1 – 27.8 mmol/L) – see Figure 18.
Figure 18. Linearity Across the Measurement Range
Results
The 36 potentially interfering substances were tested at
concentrations above the upper limit of therapeutic or normal
concentration. At the specified test concentrations, none
of the substances (except for glutathione [at both glucose
concentrations], ascorbate and xylose [at the low glucose
concentration]) had an interferent effect on the FreeStyle
Precision Pro system – see Table 6a. A substance was
considered to interfere with the test result if:

- The average difference between the test sample

and control sample exceeded 10 mg/dL
(0.55 mmol/L), for glucose concentrations
<100 mg/dL (5.55 mmol/L)
- The average difference between the test sample
and control sample exceeded 10%, for glucose
concentrations ≥100 mg/dL (5.55 mmol/L)
The 3 noted substances were further evaluated over a range of
concentrations, with the maximum test concentrations being
above the upper limit of therapeutic or normal concentration.
The concentration at which each substance was determined
to show a clinically significant effect on performance is shown
in Table 6b. The clinically significant concentration was above
the therapeutic or normal concentration in each case, therefore
these substances were not considered to have an effect on
the FreeStyle Precision Pro system. However, a limitation will
be included in the test strip insert that the product should not
be used during a xylose absorption test for malabsorption or
during intravenous infusion of high-dose ascorbic acid, where
high levels of xylose and ascorbic acid can be present.

12 of 18
 Table 6a. Paired Difference Interference Testing
Upper Limit of Difference in bias [mg/dL
Difference in bias (%) from control
Therapeutic or Normal Test Concentration, (mmol/L)] from control at
Substance at glucose of 250-350 mg/dL
Concentration,10,11 mg/dL mg/dL (mmol/L) glucose of 50-100 mg/dL
(13.88-19.43 mmol/L)
(mmol/L) (2.78-5.55 mmol/L)
Acetaminophen
3 (0.20) 20 (1.32) 1.0 (0.06) -1.7
(Tylenol, Paracetamol)
Amoxicillin 2.5 (0.07) 7.5 (0.21) -2.3 (-0.13) 0.9

Ascorbate 1.5 (0.085) 2.5 (0.14) see Table 6b 4.1

Beta-hydroxybutyrate < 7.6 (0.73) 100 (9.61) -1.4 (-0.08) 0.6

Bilirubin
1.2 (0.02) 20 (0.34) 1.6 (0.09) 2.3
(unconjugated)
Captopril (Lopirin) 0.1 (4.6 µmol/L) 0.5 (0.023) 0.8 (0.04) 0.3

Cholesterol < 200 (5.18) 500 (12.93) 0.7 (0.04) -0.2

Creatinine 1.3 (0.115) 30 (2.65) 0.6 (0.03) 0.8

Dopamine 0.03 (1.96 µmol/L) 13 (0.85) 7.7 (0.43) 3.3

EDTA 180 (6.16) 720 24.63) -0.2 (-0.01) -3.6

Ephedrine 0.01 (0.6 µmol/L) 10 (0.61) 0.3 (0.02) -1.4

Ethanol 200 (43.38) 400 (86.77) -2.2 (-0.12) -3.4

Galactose 20 (1.11) 100 (5.55) -0.2 (-0.01) -1.8

Gentisic Acid 0.6 (0.039) 3.6 (0.23) 1.9 (0.11) 1.6

Glutathione 0.18 (0.006)** 92 (2.99) see Table 6b see Table 6b

Hemaglobin 200 (0.031) 200 (0.031) -3.2 (-0.18) -2.9

Heparin 15* 60* -3.9 (-0.22) -3.3

Ibuprofen (Montril,
5 (0.24) 50 (2.42) -1.3 (-0.07) 3.2
Advil)
Icodextrin 460 460 0.5 (0.03) 0.6

L-Dopa 0.2 (0.010) 5 (0.25) 1.7 (0.09) 1.1

Lactate 20 (2.22) 100 (11.10) 2.0 (0.11) -0.3

Lactose - 100 (2.92) 3.4 (0.19) 1.7

Maltose 120 (3.51) 200 (5.84) -0.8 (-0.04) 0.2

Maltotetraose - 60 (0.90) -2.4 (-0.13) -1.1

Maltotriose - 120 (2.38) -0.3 (-0.02) 2.6

Methyl-Dopa
0.75 (0.036) 2.5 (0.12) 0.5 (0.03) -0.9
(Aldomet)
Pralidoxime Iodide 205 (7.76) 205 (7.76) -3.8 (-0.21) -0.3

Pyruvate 0.9 (0.10) 10 (1.14) 0.0 (0.0) -1.7

Salicylic Acid (from
30 (2.17) 50 (3.62) -1.2 (-0.07) -1.7
Aspirin)
Sodium+ 414 (180.0) 500 (217.4) 1.8 (0.10) 2.7

Tetracycline 0.5 (0.011) 4 (0.090) 0.4 (0.02) 0.6

Tolazamide (Tolinase) 2.8 (0.09) 100 (3.21) 2.8 (0.16) 1.1

Tolbutamide (Orinase) 10 (0.37) 100 (3.70) -0.7 (-0.04) 0.6

Triglycerides < 150 (1.7) 3000 (34) -2.6 (-0.14) -4.4

Uric Acid 7.2 (0.43) 40 (2.38) -1.2 (-0.07) -3.1

Xylose 50 (3.33) 100 (6.66) see Table 6b 5.5

*Heparin concentration in IU/mL

** Glutathione exists mainly within cells, the extracellular concentration is significantly lower than the intracellular concentration. Since FreeStyle Precision Pro does not measure intracellular
concentrations, the observed plasma glutathione concentration (2 – 6 µmol/L observed across studies12,13,14,15) has been used as the normal physiological concentration

13 of 18
 Table 6b. Dose Response Interference Testing
Upper Limit of Clinically Significant Concentration
MaximumTest
Therapeutic or Normal Glucose level 50-100 mg/dL Glucose level 250-350 mg/dL
Substance Concentration,
Concentration,10,11 mg/dL (2.78-5.55 mmol/L) (13.88-19.43 mmol/L)
mg/dL (mmol/L)
(mmol/L) mg/dL mmol/L mg/dL mmol/L
Ascorbate
1.5 (0.085) 5.0 (0.28) 2.4 0.14
(Vitamin C)
Glutathione 0.18 (0.006) 92 (2.99) 19.6 0.64 24.8 0.81
Xylose 50 (3.33) 100 (6.66) 62.0 4.13

Discussion
The point-of-care (POC) is a challenging environment for glucose monitoring. The pace is fast, and operators face many distractions.
Because blood glucose levels can drive treatment decisions, accurate and reliable testing is critical. To meet this challenge, a POC
blood glucose monitoring system must:

• Deliver accurate results regardless of blood source (i.e. capillary, venous, arterial and neonatal), haematocrit values,
oxygen partial pressures, or presence of potentially interfering substances.
• Safeguard the integrity of the testing process to reduce the risk that operators will unintentionally introduce errors that
affect the results.
Both components are essential. Even a system that delivers results consistent with a reference analyzer under laboratory conditions
may fail to meet the standard if it is susceptible to user error (e.g. short sampling, strip contamination) when used in the POC
environment. In fact, according to a 7-year hospital study, 91% to 97% of blood glucose testing errors are operator related.16

The benefits of the additional measurements made during the FreeStyle Precision Pro glucose test to enhance accuracy and allow
automatic compensation for haematocrit (in the range 15 – 65%) are evident in the results described through this paper. The clinical,
laboratory and user studies illustrate that the FreeStyle Precision Pro system has excellent accuracy and ease of use, with reduced
potential for user error.

Accuracy at the Bedside

• The FreeStyle Precision Pro system delivers accurate results regardless of blood source. In capillary, venous and
arterial clinical studies, ≥ 99.9% of the results were in the “clinically accurate” Zone A of the Consensus Error Grid. In the
neonatal clinical study, 97% of results were within Zone A (and 100% within Zones A & B) of the Leroux Error Grid.
• The FreeStyle Precision Pro system maintains accuracy across a wide range of haematocrit values and oxygen
partial pressures. Due to the automatic compensation for haematocrit, accuracy with clinical samples was maintained
across haematocrit values that ranged from 15 – 65%. Accuracy across this haematocrit range was further illustrated with
laboratory testing. Oxygen partial pressures from 4.8 – 35.7 kPa (36 – 268 mm Hg) had no clinically significant effect on
results.
• The FreeStyle Precision Pro system minimises the potential for interference. The use of GDH ensures high specificity
of the test to glucose. The use of low voltage also minimises the potential for interference from substances commonly
found in blood. Thirty-six substances were tested on the FreeStyle Precision Pro system. None of the substances tested
at high concentrations had a clinically significant effect on FreeStyle Precision Pro results. The system should not be used
during xylose absorption testing or during intravenous infusion of high dose ascorbic acid (where the concentration of
ascorbic acid in the blood can exceed 100 mg/dL [5678 µmol/L] transiently).

Convenience and Ease-of-Use

• First-time users rate the FreeStyle Precision Pro system as easy and convenient to use. The overall mean rating by
150 first time users was 5.5 (on a scale of 1-6).
• The FreeStyle Precision Pro system has a fast test time. The test strip retains the small sample volume requirement
(minimum 0.6 μL) and the system introduces a test time of 5 seconds for glucose testing.
• Blood is easy to apply to the FreeStyle Precision Pro test strip. The user can apply blood to the top or the end of the
test strip.
• The FreeStyle Precision Pro system includes WiFi capability and a 2D barcode reader. These features provide
increased flexibility and convenience for the user.

14 of 18
Reduced User Error
• The FreeStyle Precision Pro system reduces the risk associated with inadequate sample size. Erroneous results
ranging from 79% lower to 35% higher have been reported when a small drop of blood is used with certain point-of-care
blood glucose monitoring systems.17 The FreeStyle Precision Pro test strip’s sample detection electrode ensures that the
test starts only when enough blood is applied, minimizing the potential for error from “short” samples.
• The FreeStyle Precision Pro system prevents the use of expired test strips. Every FreeStyle Precision Pro test strip foil
packet has a bar code label which is scanned during the test procedure.  This process automatically calibrates the meter
for the test strip lot in use and checks the lot is within its expiration date.  The meter will prevent testing with strips that are
passed their expiration date.
• The FreeStyle Precision Pro system reduces the risk of test strip contamination. In the POC environment, accidental
exposure of test strips in a vial to air and moisture is common. Test strips exposed to air for as little as 2 hours have
been shown to cause a -26% bias.18 Inadvertent exposure to bacterial contamination has also been reported.19, 20 Each
FreeStyle Precision Pro test strip is individually wrapped in easy to open foil, to protect it against air, moisture, and other
contaminants, including potential bacterial contamination.
To help reduce the risk of transmitting infectious diseases, the Centre for Disease Control and Prevention (CDCP) has recommended
specific steps for bedside glucose monitoring, including the following:

“Unused supplies and medications taken to a patient’s bedside during fingerstick monitoring or insulin administration should not be
used for another patient because of possible inadvertent contamination.” 21

Also, CLSI POCT12-A3 recommends that unused blood glucose monitoring supplies (i.e. test strips) should not be used on another
patient: “When performing POC blood glucose testing, take precautions to avoid transmitting blood-borne diseases to health care
providers or to other patients…

After use on a patient, each device should be decontaminated per the manufacturer’s instruction. It is recommended that unused
supplies taken to a patient’s bedside during fingerstick monitoring should not be used for another patient because of possible
inadvertent contamination.” 3

As a final consideration, standard procedure in glucose monitoring is that test strips should be used immediately after removal from
the vial/foil – this requires the test strips to be taken to the patient’s bedside whilst still in the vial/foil. FreeStyle Precision Pro Blood
Glucose Test Strips have been designed to include foil wrapping of individual test strips. This enables individual test strips to be
taken to a patient’s bedside and thus reduces the volume of unused test strips at the bedside, which according to CDCP & CLSI
POCT-A3 should not be used for another patient.

Conclusion
In conclusion, the studies described in this paper show that the FreeStyle Precision Pro Blood Glucose Monitoring system delivers
accurate, reliable results whilst providing safeguards to ensure the integrity of the testing process. Specifically, the clinical studies
demonstrated the accuracy of the FreeStyle Precision Pro system for capillary, venous, arterial and neonatal blood samples when
compared to reference analyser results – accuracy of the system with all blood sample types meets more stringent accuracy
criteria than have previously been used to evaluate POC systems.2,3 Laboratory studies showed that the test strip performs well in
the presence of interfering substances and across wide ranges of haematocrit and oxygen partial pressures. In user performance
testing, the system had a high acceptance and ease-of-use rating among first-time users. Combined with features that can prevent
short sampling, strip contamination and use of expired test strips, these results show that the FreeStyle Precision Pro is uniquely
designed to provide reliable results in the challenging POC environment.

15 of 18
References
1
 g R et al, Clinical evaluation of the FreeStyle Precision Pro system. Clinica Chimica Acta, 421 (2013) 243-250
N
2
International Organisation for Standardisation. In vitro diagnostic test systems – Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. ISO
15197:2013(E)
3
CLSI. Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline – Third Edition. CLSI document POCT12-A3. Clinical and laboratory Standards Institute; 2013
4
NIST Standard Reference Materials. http://ts.nist.gov/ MeasurementServices/ReferenceMaterials/232.cfm International Organization for Standardization; 2003.
5
Passing H, Bablok W. A new biometrical procedure for testing the equality of measurements from two different analytical methods. Applications of linear regression procedures for method
comparison studies in clinical chemistry, Part I. J Clin Chem Clin Biochem 1983;21:709–20.
6
American Association of Bioanalysts. Letter to the FDA; September 13 2000 [www.fda.gov/ohrms/dockets/dailys/00/Sep00/091400/c000018.pdf (accessed 04 February 2013)]
7
Parkes JL et al, A new Consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose, Diabetes Care, 23 (2000) 1143-1148
8
P rudden EL, Siggaard – Anderson O, Tietz NW. Blood Gasses and pH in Tietz Textbook of Clinical Chemisrty, 2nd edition, 1994, p1394.
9
Leroux M et al, Glucose meter use in nurseries: Error grid values clinical accuracy. Laboratory Medicine, 25 (1994) 592-595
10
Tietz Textbook of Clinical Chemistry. 3rd ed. Philadelphia: W.B. Saunders Co.; 1999. p. 1788–846.
11
C LSI. Interference testing in clinical chemistry; approved guideline – second edition. CLSI document number EP7-A2. Clinical and Laboratory Standards Institute; 2005.
12
F. Michelet, et al, Blood and plasma glutathione measured in healthy subjects by HPLC: relation to sex, aging, biological variables, and life habits, Clinical Chemistry, 1995, 41, 1509 – 1517
13
D. Jones, et al, Glutathione measurement in human plasma evaluation of sample collection, storage and derivatization conditions for analysis of dansyl derivatives by HPLC. Clinical Chimica Acta,
1998, 275, 175 – 184
14
J. D. Adams, et al, Quantification of glutathione and glutathione disulfide in human plasma. Clinical Chemistry, 1987, 33, 1675 – 1676
15
M. A. Mansoor, et al, Determination of the in vivo redox status of cysteine, cysteinylglycine, homocysteine, and glutathione in human plasma. Analytical Biochemistry, 1992, 200, 218 – 219
16
Nobels F et al, Feasibility of a quality assurance programme of bedside blood glucose testing in a hospital setting: 7 years’ experience. Diabet Med. 21(12) (2004) 1288-91.
17
Shalapay CE et al, Effects of applying insufficient blood on three blood glucose monitoring systems. Clin Chem, 50 (2004) (Suppl 6):A169
18
Keffer P et al, Instability of blood glucose test strips in uncapped vials. Diabetes, 47 (1998) (Suppl.1):A6.
19
Decousser et al, Bacterial contamination of glucose test strips: Not to be neglected. Letters to Editor, American Journal of Infection control, (2011) 611-613
20
Ng et al, Multicenter evaluation of bacterial contamination of glucose test strips, Clinica Chimica Acta, 413 (2012) 1485-1487
21
Diabetes and Viral Hepatitis: Important Information on Glucose Monitoring, Centers for Disease Control: http://www.cdc.gov/hepatitis/Settings/GlucoseMonitoring.htm

Appendix
Table 7. Clinical Regression Statistics, MARD, Precision

Regression
Correlation Mean Absolute Relative Mean Paired
Sample type & reference analyser Regression Slope Intercept, mg/dL
Coefficient, r Difference, % Replicate CV, %
(mmol/L)
Capillary vs YSI (plasma equivalent) 0.99 1.0 -2.5 (-0.14) 5.0 3.3

Arterial vs YSI (plasma equivalent) 0.98 1.08 -9.2 (-0.51) 3.9 -*

Arterial vs Beckman DxC 800 0.98 1.07 -9.5 (-0.53) 4.3 -*

Venous vs YSI (plasma equivalent)

0.99 0.98 5.4 (0.3) 4.2 2.2
EDTA
Venous vs YSI (plasma equivalent)
0.99 1.00 4.3 (0.2) 4.4 2.3
Heparin
Venous vs YSI Plasma
0.99 0.98 6.0 (0.3) 4.4 2.2
EDTA
Venous vs YSI Plasma
0.99 1.00 4.6 (0.3) 4.8 2.3
Heparin

Neonatal vs Roche Cobas 6000 0.98 1.03 -4.6 (-0.3) 5.8 2.8

*Study only included one test per sample, so unable to determine mean paired replicate CV%.

16 of 18
 Table 8. System Accuracy and Error Grid Analyses
Venous vs Venous vs
Capillary vs Arterial vs Arterial vs Venous vs YSI Venous vs YSI Neonate vs
YSI (plasma YSI (plasma
YSI (plasma YSI (plasma Beckman DxC Plasma Plasma Roche Cobas
equivalent) equivalent)
equivalent) equivalent) 800 EDTA Heparin 6000
EDTA Heparin
< 100 mg/dL 136 / 222 46 / 60 36 / 54 66 / 108 73 / 108 72 / 108 70 / 108 317 / 419
(5.55 mmol/L) (61.3%) (76.7%) (66.7%) (61.1%) (67.6%) (66.7%) (64.8%) (76%)
Within 5% /
≥100 mg/dL 532 / 751 224 / 300 216 / 306 402 / 552 384 / 552 400 / 552 359 / 552
±5mg/dL 32 / 52 (62%)
(5.55 mmol/L) (70.8%) (74.7%) (70.6%) (72.8%) (69.6%) (72.5%) (65.0%)
(0.27 mmol/L)
Combined 668 / 973 270 / 360 252 / 360 468 / 660 457 / 660 472 / 660 429 / 660 349 / 471
Results (68.7%) (75.0%) (70.0%) (70.9%) (69.2%) (71.5%) (65.0%) (74%)
< 100 mg/dL 212 / 222 59 / 60 49 / 54 97 / 108 101 / 108 96 / 108 98 / 108 410 / 419
(5.55 mmol/L) (95.0%) (98.3%) (90.7%) (89.8%) (93.5%) (88.9%) (90.7%) (98%)
Within ±10%
≥100 mg/dL 717 / 751 290 / 300 290 / 306 536 / 552 514 / 552 527 / 552 507 / 552
/ ±10mg/dL 43 / 52 (83%)
(5.55 mmol/L) (95.5%) (96.7%) (94.8%) (97.1%) (93.1%) (95.5%) (91.8%)
(0.55 mmol/L)
Combined 928 / 973 349 / 360 339 / 360 633 / 660 615 / 660 623 / 660 605 / 660 453 / 471
Results (95.4%) (96.9%) (94.2%) (95.9%) (93.2%) (94.4%) (91.7%) (96%)
< 100 mg/dL 216 / 222 59 / 60 53 / 54 103 / 108 107 / 108 101 / 108 104 / 108 415 / 419
(5.55 mmol/L) (97.3%) (98.3%) (98.1%) (95.4%) (99.1%) (93.5%) (96.3%) (99%)
Within ±12.5%
≥100 mg/dL 731 / 751 297 / 300 299 / 306 546 / 552 535 / 552 549 / 552 532 / 552
/ ±12mg/dL 50 / 52 (96%)
(5.55 mmol/L) (97.3%) (99.0%) (97.7%) (98.9%) (96.9%) (99.5%) (96.4%)
(0.67 mmol/L)
Combined 947 / 973 356/360 352/360 649/660 642/660 650/660 636 / 660 465 / 471
Results (97.3%) 98.9% (97.8%) (98.3%) (97.3%) (98.5%) (96.4%) (99%)
< 100 mg/dL 222 / 222 60 / 60 54 / 54 106 / 108 108 / 108 104 / 108 108 / 108 141 / 141
(5.55 mmol/L) (100.0%) (100.0%) (100.0%) (98.1%) (100.0%) (96.3%) (100.0%) (100%)
Within ±15%
≥100 mg/dL 744 / 751 298 / 300 305 / 306 552 / 552 552 / 552 551 / 552 547 / 552
/ ±15mg/dL 52/52 (100%)
(5.55 mmol/L) (99.1%) (99.3%) (99.7%) (100.0%) (100.0%) (99.8%) (99.1%)
(0.83 mmol/L)
Combined 966 / 973 358 / 360 359 / 360 658 / 660 660 / 660 655 / 660 655 / 660 471 / 471
Results (99.3%) (99.4%) (99.7%) 99.7% (100.0%) (99.2%) (99.2%) (100%)
< 75 mg/dL 108 / 108 6/6 6/6 18 / 18 18 / 18 18 / 18 18 / 18 235/235
(4.2 mmol/L) (100.0%) (100.0%) (100.0%) (100.0%) (100.0%) (100.0%) (100.0%) (100%)
Within ±20%
≥ 75 mg/dL 864 / 865 354 / 354 354/354 641 / 642 642 / 642 641 / 642 642 / 642 236 / 236
/ ±15mg/dL
(4.2 mmol/L) (99.9%) (100.0%) 100% (99.8%) (100.0%) (99.8%) (100.0%) (100%)
(0.83 mmol/L)
Combined 972 / 973 360 / 360 360 / 360 659 / 660 660 / 660 659 / 660 660 / 660 471 / 471
Results (99.9%) 100.0% 100.0% 99.8% 100.0% (99.8%) (100.0%) (100%)
972 / 973 359 / 360 359 / 360 660 / 660 660 / 660 660 / 660 660 / 660 457 / 471
Zone A
(99.9%) (99.7%) (99.7%) (99.8%) (100.0%) (99.8%) (100.0%) (97.0%)*
1 / 973 1 / 360 1 / 360 0 / 660 0 / 660 0 / 660 0 / 660 14 / 471
Zone B
(0.1%) (0.3%) (0.3%) (0.0%) (0.0%) (0.0%) (0.0%) (3.0%)*
Consensus
Error Grid / Zone C - - - - - - - -*
Leroux Error
Grid* Analysis Zone D
- - - - - - - -*

Zone E - - - - - - - -*

973 / 973 360 / 360 360 / 360 660 / 660 660 / 660 660 / 660 660 / 660 471 / 471*
Total
(100) (100) (100) (100) (100) (100) (100) (100)

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FreeStyle and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions.
Other trademarks are the property of their respective owners.

© 2013 Abbott ART25397 Rev A 10/13

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