Hemoglobin determination Biotest Hemoglobin System Accuracy and precision Biotest Medizintechnik GmbH.

Hemoglobin determination Biotest Hemoglobin SystemAccuracy and precision

Biotest Medizintechnik GmbH

2

Products

• Cuvette– Biotest Hemoglobin

• Measuring device– Biotest Hemoglobin Tester

3

Function

• Cuvette

• Blood capillary, reagent and measuring cuvette in one.

• Biotest Hemoglobin Tester

Photometer with integrated control and digital display

4

Function - Cuvette

• Chemical reaction

Free Haemoglobin

Sodium nitrite Sodium azid

Erythrocytes

Haemolysis by sodium desoxycholat

Methemo-globin

Azid-Methaemo-globin

5

Function - Cuvette

• Absorbance curve

6

Measurementsn = 30

Mean g/dl SD g/dl CV & Mean g/dl SD g/dl CV &Sample 1 5,50 g/dl 0,09 g/dl 1,61 % 5,46 g/dl 0,08 g/dl 1,47 %Sample 2 7,42 g/dl 0,07 g/dl 0,93 % 7,47 g/dl 0,07 g/dl 0,91 %Sample 3 7,90 g/dl 0,12 g/dl 1,46 % 7,97 g/dl 0,09 g/dl 1,12 %Sample 4 9,82 g/dl 0,06 g/dl 0,61 % 10,03 g/dl 0,12 g/dl 1,23 %Sample 5 10,13 g/dl 0,10 g/dl 1,02 % 10,05 g/dl 0,12 g/dl 1,17 %Sample 6 11,70 g/dl 0,09 g/dl 0,77 % 11,65 g/dl 0,07 g/dl 0,58 %Sample 7 11,88 g/dl 0,24 g/dl 2,04 % 11,75 g/dl 0,10 g/dl 0,81 %Sample 8 12,77 g/dl 0,08 g/dl 0,63 % 12,68 g/dl 0,10 g/dl 0,81 %Sample 9 13,48 g/dl 0,11 g/dl 0,84 % 13,47 g/dl 0,10 g/dl 0,76 %Sample 10 13,51 g/dl 0,08 g/dl 0,59 % 13,50 g/dl 0,13 g/dl 0,93 %Sample 11 13,65 g/dl 0,13 g/dl 0,94 % 13,51 g/dl 0,08 g/dl 0,60 %Sample 12 14,10 g/dl 0,21 g/dl 1,50 % 14,04 g/dl 0,18 g/dl 1,29 %Sample 13 14,39 g/dl 0,08 g/dl 0,56 % 14,41 g/dl 0,10 g/dl 0,69 %Sample 14 14,76 g/dl 0,10 g/dl 0,65 % 14,72 g/dl 0,09 g/dl 0,62 %Sample 15 14,82 g/dl 0,17 g/dl 1,15 % 14,82 g/dl 0,10 g/dl 0,69 %Sample 16 15,21 g/dl 0,10 g/dl 0,66 % 15,14 g/dl 0,14 g/dl 0,94 %Sample 17 15,59 g/dl 0,13 g/dl 0,82 % 15,66 g/dl 0,13 g/dl 0,82 %Sample 18 15,83 g/dl 0,10 g/dl 0,64 % 15,83 g/dl 0,16 g/dl 0,99 %Sample 19 18,36 g/dl 0,18 g/dl 0,95 % 18,57 g/dl 0,10 g/dl 0,54 %Sample 20 19,37 g/dl 0,18 g/dl 0,95 % 19,54 g/dl 0,11 g/dl 0,59 %Mean value 13,01 g/dl 0,12 g/dl 0,97 % 13,01 g/dl 0,11 g/dl 0,88 %

HiCN Biotest

7

Measurements

Linearity and precision, n = 20 measurements by each blood sample.

y = 1,0064x - 0,0773R² = 0,9992

5,00

10,00

15,00

20,00

5,0 g/dl 10,0 g/dl 15,0 g/dl 20,0 g/dl

Mean value HiCN, i g/dl

Bio

tes

t H

em

og

lob

in S

ys

tem

, g

/dl

8

MeasurementsVergleich venöses Blut

Biotest Hemoglobin Meßsystem mit HiCN-Methode

y = 0,9965x + 0,0363

R2 = 0,9981

0,00

5,00

10,00

15,00

20,00

25,00

0,00 5,00 10,00 15,00 20,00 25,00

HiCN-Methode Hb [g/dl]

Bio

tes

t S

yste

m H

b [

g/d

l]

Biotest

Linjär(Biotest)

n = 300

9

Function - Tester

• Photometer; two wave lengths

• Evaluation and calculation

• Reading

Evaluation

10

Self calibration • 100% green light, 100% red light and dark current• Compared to moment of calibration• If necessary automatic adjustment of LED current

Evaluation

11

Absorption 256 g/L

12 bits = 4000 ”steps”

Resolution

0 = 100 % light 470 – 880 nm

Resolution

Max deviation = +/- 0,75 % or +/- 30 steps

12

Calibration

Absorption 256 g/L

12 bits = 4000 ”steps”0 = 100 % light 470 – 880 nm

Two points of calibration for linearity; 80 and 220 g/L

Three control levels for linearity 120, 150, 180 g/L

13

Function - Tester

• Calculation of HbE

xtin

ctio

n

500 570 600 700 800 880Wave length [nm]

Turbidity

Turbidity

14

Hb

Time

0 min 1 min 2 min 3 min

Capillary blood

15

Results - Introduction

• Accuracy– How close to true value is the result

• Precision– How close to each other are repeated

measurements with the same sample

16

Results - Introduction

• Accuracy and precision

High accuracyLow precision

Low accuracyHigh precision

High accuracyHigh precision

17

Results - Introduction• Accuracy:

– Deviation (mean) in g/L

– Preferred; deviation in %

• Precision:– Standard deviation SD

– Preferred; Coefficient of variation, CV %

18

Results

Precision with control blood (n=50)

0

5

10

15

20

25

30

12,1 12,2 12,3 12,4 12,5 12,6 12,7

Result [g/dl]

Nu

mb

ers

Mean value 12,39 g/dlSD 0,084 g/dlCV 0,68 %

19

Features

• Cuvette– Aimed for Hb-measurement with Biotest-Hemoglobin-Tester

and compatible instruments– High accuracy and precision– Can be used for venous, capillary and arterial blood– Developed to be price worth due to latest production and

control technique

20

Features

• Tester Automatic calibration:

no calibration or test cuvette needed Cuvette holder minimizing the risk of contamination Automatic monitoring of power supply with fast loading of batteries

(1 hour loading > 40 hours of measuring) Automatic shut off with latest value saved Measures only cuvettes with properly haemolysed blood

21

Summary

• High accuracy and precision• Easy and reliable system• Long time use on battery power

22

Results - Introduction