Contour BLOOD GLUCOSE MONITORING SYSTEM Podręcznik Użytkownika Pobierz pdf (Strona 34)

TECHNICAL

INFORMATION

TECHNICAL

INFORMATION

Technical Information - Precision

Technical Information - Accuracy

Accuracy

Table 1 – System accuracy results for glucose

concentration < 5.55 mmol/L

Difference range in values

between YSI laboratory

reference method and

CONTOUR NEXT meter

Within ±

0.28

mmol/L

Within ±

0.56

mmol/L

Within ±

0.83

mmol/L

Number (and percent)

of samples within

specifiedrange

167 of 180

(92.8%)

179 of 180

(99.4%)

180 of 180

(100%)

Table 2 – System accuracy results for glucose

concentration ≥ 5.55 mmol/L

Difference range in values

between YSI laboratory

reference method and

CONTOUR NEXT meter

Within ±

10%

Within ±

15%

Number (and percent)

of samples within

specifiedrange

319 of 420

(76.0%)

412 of 420

(98.1%)

419 of 420

(99.8%)

A repeatability study was conducted with the CONTOUR

blood glucose monitoring system using 5 venous

whole blood specimens with glucose levels from 2.2 to

17.9mmol/L. Multiple replicates (n=300) were tested using

multiple CONTOUR NEXT blood glucose meters and 3 lots

of CONTOUR

NEXT blood glucose test strips. The following

precision results were obtained.

Table 4 – System repeatability results for C

ONTOUR NEXT

meter using C

ONTOUR NEXT test strips

Mean,

mmol/L

Pooled

Standard

Deviation

95% Confidence

Interval of Standard

Deviation, mmol/L

Coefficient of

Variation, %

2.2 0.05 0.043 – 0.051 2.1

4.8 0.07 0.062 – 0.073 1.4

6.8 0.09 0.082 – 0.097 1.3

11.4 0.15 0.138 – 0.164 1.3

18.2 0.26 0.238 – 0.282 1.4

Intermediate precision (which includes variability across

multiple days) was evaluated using 3 control solutions. With

each of 3 lots of C

ONTOUR NEXT Test Strips, each control

was tested once on each of 10 instruments on 10 separate

days for a total of 300 readings.

Table 5 – System intermediate precision results for

ONTOUR NEXT meter using CONTOUR NEXT test strips

Control

Level

Mean,

mmol/L

Standard

Deviation,

mmol/L

95% Confidence

Interval of Standard

Deviation, mmol/L

Coefficient

of Variation,

Low 2.41 0.04 0.036 – 0.043 1.6

Normal 7.16 0.10 0.093 – 0.111 1.4

High 21.30 0.35 0.321 – 0.380 1.6

Acceptance criteria in ISO 15197: 2013 are that 95% of all

differences in glucose values (i.e., between reference method and

meter) should be within ±0.83 mmol/L for glucose values less than

5.55 mmol/L, and within ±15% for glucose values greater than or

equal to 5.55 mmol/L.

Technical Information

User Accuracy

The CONTOUR

NEXT blood glucose monitoring system

was tested in 100 capillary blood samples using 600

CONTOUR

NEXT test strips. Two replicates were tested

with each of 3 lots of CONTOUR NEXT test strips for a

total of 600 readings. Results were compared to the YSI

glucose analyzer, which is traceable to the CDC hexokinase

method.

The tables below compare the performance of the

2methods.

Table 3 – System accuracy results for glucose

concentrations between 1.3 mmol/L and 30.6mmol/L

Within ± 0.83 mmol/L or ±15% 599 of 600 (99.8%)

Precision

A study evaluating glucose values from fingertip capillary

blood samples obtained by 221 lay persons showed

the following results: 100% within ± 0.83 mmol/L of the

medical laboratory values at glucose concentrations below

5.55mmol/L and 98.9% within ±15% of the medical

laboratory glucose concentrations at or above 5.55mmol/L.

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