CONTROL BLOOD

- What is control blood?

- Why do they use it?
- Why do we do it?
- How do we do it?
- Where are we now?
- Where are we going to?
 What is control blood?

- The control blood products are quality control materials to monitor

automated electronic instrument determination of blood cell values
in various established clinical hematology procedures.

- The control blood should contain particles that represent all of the
cellular elements of fresh blood, namely White Blood Cell (WBC),
Red Blood Cell (RBC), Platelet (PLT), as well as a liquid component
that serves as a suspending media similar to the function of human
plasma.
 Why do they use it?

- Governments have mandated that there be a method to verify

the integrity of the instrument using a blood control.

- In order to ensure that a hematology instrument is working

properly.

- The function of a hematology control product is to provide a

means of ascertaining the accuracy and precision of the instrument
used to make the next specific blood cell measurements: white
blood cell count (WBC), red blood cell count (RBC), hematocrit
(HCT), hemoglobin (HGB), mean corpuscular volume (MCV),
mean corpuscular hemoglobin concentration (MCHC), and platelet
parameters such as platelet count.
 Why do we do it?

- Increasing user complains with regard to quality and stability of

distributed control blood (manufactured by R&D).

- In order to reduce our dependence on control blood

manufacturers due to there are only 2 notable control blood
manufacturers (Streck, R&D) all over the world.

- A matter of time that governments oblige reagent suppliers to

supply control blood too which increases our dependence on
manufacturers and we have to prepare for this.

Confucius said: „If a man does not give thought to problem

which are still distant he will be worried by them when they
come nearer.”
How do we do it?

*Measured in BC3000
How do we do it?

*Measured in BC3000
How do we do it?

*Measured in Sysmex Kx-21

How do we do it?
 How do we do it?

- We have developed a new technology which enables to

produce control blood for any type of three part differential
hematology instrument.

- By our method, varying levels of MCV, concentrations of WBC,

RBC, PLT, distribution of WBC can be easily obtained to simulate
normal as well as abnormally high or low cases.

- Our control blood have a long term stability (expiry is 6 months

from manufactured date, open vial stability is 30 days).
Open vial stability ( D-Cell 60)

(storage 2-8°C)
 Open vial stability ( D-Cell 60)
MCV change
102,0

97,0

92,0
MCV (fl)

87,0

82,0

77,0

72,0
1 8 15 22 29 36 43 50 57 64 71 78 85 92 99 106 113 120 127

time (day)

(storage 2-8°C)
 Open vial stability (D-Cell 60)
WBC change
10,2

9,2

8,2
WBC (10^9/L)

7,2

6,2

5,2

4,2
0 7 14 21 28 35 42 49 56 63 70 77 84 91 98 105 112 119 126
time (day)

(storage 2-8°C)
 Open vial stability ( D-Cell 60 )
PLT change
310,0

270,0

230,0
PLT (10^9/L)

190,0

150,0

110,0

70,0
0 7 14 21 28 35 42 49 56 63 70 77 84 91 98 105 112 119 126
itime (day)

(storage 2-8°C)
 Open vial stability ( D-Cell 60 )
HGB change
161,0

155,0

149,0
HGB (g/L)

143,0

137,0

131,0

125,0
0 7 14 21 28 35 42 49 56 63 70 77 84 91 98 105 112 119 126
itime(day)

(storage 2-8°C)
 Open vial stability ( D-Cell 60 )
MCV change
102,0

97,0

92,0
MCV (fl)

87,0

82,0

77,0

72,0
1 8 15 22 29 36 43 50 57 64 71 78 85 92 99 106 113 120 127

time (day)

(storage 2-8°C)
 Open vial stability ( D-Cell 60 )
WBC change
10,2

9,2

8,2
WBC (10^9/L)

7,2

6,2

5,2

4,2
0 7 14 21 28 35 42 49 56 63 70 77 84 91 98 105 112 119 126
time (day)

(storage 2-8°C)
 Open vial stability ( D-Cell 60 )

PLT change
310,0

270,0

230,0
PLT (10^9/L)

190,0

150,0

110,0

70,0
0 7 14 21 28 35 42 49 56 63 70 77 84 91 98 105 112 119 126
time (day)
(storage 2-8°C)
Controll blood logistics issues

• Packing

• Air freight

• Cool shipment

• Custom clearance

• Forecasted, ordering
• Shelf life 4 -6 months
 Open stability at room temperature ( D-Cell 60 )

MCV change
97

92
MCV (fL)

87

82

77
0 5 10 15 20 25 30

time (day)

(storage 20-22°C)
 Open stability at room temperature ( D-Cell 60 )

HGB change
160

154

148
HGB (g/L)

142

136

130

124
0 5 10 15 20 25 30
time (day)

(storage 20-22°C)
 Open stability at room temperature ( D-Cell 60 )

WBC change
9,2

8,2
WBC (10^9/L)

7,2

6,2

5,2
0 5 10 15 20 25 30

time (day)
(storage 20-22°C)
 Open stability at room temperature ( D-Cell 60 )

PLT change
250

230

210
PLT (10^9/L)

190

170

150

130
0 5 10 15 20 25 30

time (day)

(storage 20-22°C)
 Shelf life ( D-Cell 60 )

MCV change
102,0

97,0

92,0
MCV (fL)

87,0

82,0

77,0

72,0
0 7 14 21 28 35 42 49 56 63 70 77 84 91 98 105112119126133140147154161168175182189196
time (day) (storage 2-8°C)
 Shelf life ( D-Cell 60 )
HGB változás
161,0

155,0

149,0
HGB (g/L)

143,0

137,0

131,0

125,0
0 7 14 21 28 35 42 49 56 63 70 77 84 91 98 105 112 119 126 133 140 147 154 161 168 175 182 189 196
idó (nap)
(tárolás 2-8°C)
 Shelf life ( D-Cell 60 )

WBC change
10,2

9,2

8,2
WBC (10^9/L)

7,2

6,2

5,2

4,2
0 7 14 21 28 35 42 49 56 63 70 77 84 91 98 105 112 119 126 133 140 147 154 161 168 175 182 189 196
time (day)
(storage 2-8°C)
 Shelf life ( D-Cell 60 )

PLT change
310,0

270,0

230,0
PLT(10^9/L)

190,0

150,0

110,0

70,0
0 7 14 21 28 35 42 49 56 63 70 77 84 91 98 105 112 119 126 133 140 147 154 161 168 175 182 189 196
time (day) (storage 2-8°C)
 D-Check D (3 part diff. control)

 D-Check D Plus (3 part diff. control)

 D-Check 5Diff (5 part diff control)

 D-Check 5Diff Plus (5part diff + RETIC + NRBC) NEW

 D-Check VET (3 part diff veterinary control)

 D-Check VET 5Diff (5 part diff veterinary control)

Distribution of WBCs sub-populations of third party control dedicated to
CD-3700 instrument on 5 different 5part diff hematology system

9,00

8,00

7,00

6,00
BASO# /Non-diff.
5,00 EOS#
NEU#
4,00
MONO#
3,00
LYMPH#
2,00

1,00

0,00
CD-3700 XE-2100 ADVIA-120 Coulter LH- Mindray
D-CellBC-5500
5D
500
NB: this third party control dedicated to CD-3700 instrument cannot be
used as control for other instruments
Distribution of WBCs sub-populations of third party control dedicated to
XE-2100 instrument on 5 different 5part diff hematology system

8,00

7,00

6,00
BASO# /Non-diff.
5,00
EOS#
4,00 NEU#
MONO#
3,00
LYMPH#
2,00

1,00

0,00
CD-3700 XE-2100 ADVIA-120 Coulter LH- Mindray
D-Cell 5DBC-5500
500
NB: this third party control dedicated to Sysmex XE-2100 instrument
cannot be used as control for other instruments
Distribution of WBCs sub-populations of third party control dedicated to
ADVIA-120 instrument on 5 different 5part diff hematology system

9,00

8,00

7,00

6,00 BASO#/Non-diff.
EOS#
5,00
NEU#
4,00
MONO#
3,00 LYMPH#

2,00

1,00

0,00
CD-3700 XE-2100 ADVIA-120 Coulter LH- Mindray
D-Cell 5DBC-5500
500
NB: this third party control dedicated to ADVIA-120 instrument cannot be
used as control for other instruments
Distribution of WBCs sub-populations of third party control dedicated to
Coulter LH-500 instrument on 5 different 5part diff hematology system

10,00

9,00

8,00

7,00
BASO#
6,00 EOS#
5,00 NEU#

4,00
MONO#
LYMPH#
3,00

2,00

1,00

0,00
CD-3700 XE-2100 ADVIA-120 Coulter LH- D-Cell 5D
500
Mindray BC-5500

NB: this third party control dedicated to Coulter LH-500 instrument

cannot be used as control for other instruments
Distribution of WBCs sub-populations of third party control dedicated to
Mindray BC-5500 instrument on 5 different 5part diff hematology system

9,00

8,00

7,00

6,00
BASO#
5,00 EOS# /Non-diff.
NEU#
4,00
MONO#
3,00
LYMPH#
2,00

1,00

0,00
CD-3700 XE-2100 ADVIA-120 Coulter LH- D-Cell 5D
500 Mindray BC-5500

NB: this third party control dedicated to Mindray BC-5500 instrument

cannot be used as control for other instruments
Distribution of WBC sub-populations of D-Check 5 Diff control on 5 different systems
WBC
109/L

Mindray BC-5500

NB: Diagon universal D-Check 5Diff control is suitable control for all
mentioned instruments
 D-Check 5Diff Plus „Normal” on Mindray BC-6800
Diff channel RET channel NRBC channel
D-Check 5Diff Plus „Normal”
on Sysmex XN 1000
 D-Check D
Diagon D-Cell 60, D-Cell 60Cs

Mindray BC-3200, BC-3000Plus, BC-2900, BC-2800, BC-1800

ABX Micros 60, Pentra 60 Series*, Pentra 120*

Siemens ADVIA 60
Beckman Coulter AcT 3Diff
Nihon Kohden MEK-6318, MEK-6400, MEK-6410, MEK-6420, MEK-7722*
Others ABACUS, Erba Elite 3, Drew D3

* Non diff. parameters

D-Check D Plus

SYSMEX K-800, K1000, K4500, KX-21, KX-21N

ABBOTT CD-1600
 D-Check 5Diff
SYSMEX XN-1000, XE-2100, XT-2000, XS-1000, SF-3000

MINDRAY BC-6800, BC-6600, BC-5800, BC-5500, BC-5380

ABBOTT Cell Dyn-3700, Cell-Dyn-3500

SIEMENS ADVIA-2120, ADVIA-120

NIHON-KOHDEN MEK-7722
Abacus 5, Erba Elite 5, ANALYTICON BIOTECHNOLOGIES
Others
Hemolyzer 5
 D-Check 5Diff Plus (5Diff+RETIC+NRBC)
SYSMEX XN-1000, XE-2100, XT-2000, XS-1000, SF-3000

MINDRAY BC-6800, BC-6600, BC-5800, BC-5500, BC-5380

ABBOTT Cell Dyn-3700, Cell-Dyn-3500

SIEMENS ADVIA-2120, ADVIA-120

NIHON-KOHDEN MEK-7722
Abacus 5, Erba Elite 5, ANALYTICON BIOTECHNOLOGIES
Others
Hemolyzer 5
 Competitor control stability
R&D Systems
Control Characteristics Shelflife Open vial stability
CBC 3D 3 diff. control 105 days 14 days
CBC ST Plus 3 diff. control 105 days 14 days
CBC 3K 5 diff. control 75 days 8 days
CBC 4K 5 diff. control 75 days 8 days
CBC-Tech 5 diff. control 75 days 14 days
CBC 5D 5 diff. control 105 days 14 samples within 14 days
CBC X 5 diff. control 75 days 15 samples within 15 days

Streck
Control Characteristics Shelflife Open vial stability
Para 12 3 diff. control 110 days 14 days
Para 12 Extended 3 diff. control 190 days 30 days
Para Check 3 diff. control 132 days 14 days
Para 12 Plus 5 diff. control 75 days 7 days
Para Tech 5 diff. control 75 days 10 days
STaK-Chex 5 diff. control 105 days 14 days
 Competitor control stability
Bio-Rad
Control Characteristics Shelflife Open vial stability
Liquichek™ Hematology-16 Control 3 diff. control 160 days 21 days
Liquichek™ Hematology-16T Control 3 diff. control 160 days 18 days
Liquichek™ Hematology Control (A) 5 diff. control 120 days 21 days
Liquichek™ Hematology Control (A-I) 5 diff. control 75 days 8 days
Liquichek™ Hematology Control (C) 5 diff. control 105 days 14 samples within 14 days
Liquichek™ Hematology Control (S) 5 diff. control 75 days 14 days
Liquichek™ Hematology Control (X) 5 diff. control 75 days 15 samples within 15 days

AVANTOR (JT Baker)

Control Characteristics Shelflife Open vial stability
8 parameter control 8 parameter control 4/6 months 4 weeks
3 Diff Control 3 diff. control 4/6 months 3 weeks
CA Diff Control 3 diff. control 4 months 3 weeks
K Diff Control 3 diff. control 4 months 3 weeks
5D Control 5 diff. control 3 months 2 weeks
ADV Diff Control 5 diff. control 3 months 2 weeks
BC Diff 5 Control 5 diff. control 3 months 2 weeks
CD Diff Control 5 diff. control 3 months 2 weeks
DIA Diff 5 Control 5 diff. control 3 months 2 weeks
SF Diff Control 5 diff. control 3 months 2 weeks
XE Diff Control 5 diff. control 3 months 2 weeks
 Competitor control stability

Diagon
Control Characteristics Shelflife Open vial stability
D-Check D 3 diff. control 6 months 30 days
D-Check D Plus 3 diff. control 6 months 30 days
D-Check 5Diff 5 diff. control 4 months 21 days

Abbott
Control Characteristics Shelflife Open vial stability
Cell-Dyn 29 Plus 5 diff. control 75 days 7 days

Sysmex
Control Characteristics Shelflife Open vial stability
e-Check XE 5 diff. control 8 weeks 7 days
 STABILITY

Open vial stability Shelf life

D-Check D 30 days 6 months

D-Check D Plus 30 days 6 months

D-Check 5Diff 21 days 4 months

D-Check 5Diff Plus 21 days 4 months

D-Check VET 30 days 6 months

D-Check VET 5Diff 21 days 4 months