CERA-CHEK Hb Plus ACCURACY DATA

CERAGEM MEDISYS R&D DEPT

CERA-CHEK Hb Plus (Accuracy)

COMPARISON TO STANDARD METHOD
1. 2. 3. SAMPLE: CAPILLARY BLOOD 75 SAMPLES( 15 Patients, sample from each fingers per person. reference 1point , strip 1point , 5points) PRODUCT : CERA-CHEK Hb Plus (1 Lot) STANDARD PRODUCT: sysmex KX-21N

Regression plot
Thumb 25 Meter hemoglobin concentration(g/dL) Index finger Middle finger Ring finger Little finger / Pinky

20

15

10

0 0.0 5.0 10.0 15.0 20.0 25.0

RESULT
STANDARD PRODUCT

Sysmex KX-21N caillary blood glucose concentration (g/dL)

BASED ON ABOVE RESULT, RESULT FROM DIFFERENT FINGERS ARE SHOWN WITHIN 20% COMPARE TO THE
Bold line: 20%

CERA-CHEK Hb Plus (precision)

Precision
10.0 9.0

8.0
7.0 C.V(%) 6.0 5.0

4.0
3.0 2.0 1.0 2.2 2.4 2.2

3.4 1.7 2.3

3.0

2.7

3.3

2.7

2.9

3.4

2.9

3.0

2.7

2.7

0.0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 avg SAMPLE (PERSON)

EVERAGE C.V SHOWS 2.7 WHICH PROVES THERE IS NO DIFFERENCE FROM EACH FINGERS.