I.

LINEARITY STUDY
! " #
$ % % &'

( ) ! !! "
*

*+, -+'+ .
*+,/ -+'+0 .
% &*+,-+++' + .
$ * 1, 1 2 "

& '

A. Red Blood Cells Linearity

-
! ! " # # # - $" ##
% - 1 - / 0 1
% / -0 1 - + 1
% + 1
% /2 1
% "
%

&' -/ 1 - +0

() ! * 2 -2 1- - 2 0

+, ++ ++ ++ + ++ + + 1
+, 1- +0 + / + ++ 0+
 B. White Blood Cells

- / - $ #
! ! $ - - "
% / -2 21 1/ + 0- + 0 -
% - 20 + 1/ 01 01 0
% 2 - 21 10 0 0 2
% 0 - - 20 1/ + 01 0 +
% "
%

&' - - 2- 10 01 0

() ! * -0 2 2 2 00 12 1 ++

+, + ++ 0/ 1 2 1+ - / 0 -
+, + ++ 2- / 0/ 1 + 1 -

C. PLATELET

- 0 2 #
! ! #.
" " /- + .
" + /- ." -+ " ##
% 1 2 1 22 1 // 01 0
% 1+ 2- 2 - / 0 -1
% / 0- 2 2 ++ 1 0 +
% -/ 1 1 1 0- 0-+
% "
%

&' 0 -+ 2 0 1- 12 / 01++

() ! * - -+ 21- /- - -+ /+++

+, + 2 + 0+
+, -/ + ++ 2 - 2/ -

1
 D. HEMOGLOBIN

-
! ! " # # # - $" ##
% + 0+ + + 0 ++
% + 0+ + 2 +
% + / +
% +
% "

&' ++ 0 ++ +- ++ / + +/

() ! * ++ 0 ++ ++ ++ 2 ++ + ++

+, + ++ + ++ + +- + ++ + / + +/
+, + ++ + ++ +0 + ++ 1+ +

E. CONCLUSION

& # " " " 3

"

/
+ !! + ++ 4+ 1 4 15
+0 !! + 4 + +/ 4 5
$ " +- 1 4+ 4 5
% & + !! - +++ 4 + 4 -5

-
II. LOW LINEARITY STUDY
"
! " # $ % % &'

( ) ! ! ) ! ++5 /+5 -+5 +5 +5 -5

" " *

*+ 1 6 / /+'+ .
*+ 1 6 1 ' +0 .
% &* 6 1 ' +0 .
$ *+ 1 6 "

& 7 # '

# # $

"
! ! " # # "# # ##
WBC LOW RANGE LINEARITY
% + 1+ + + /+ 2+ - -+ / /+ 9
% + 1+ + 2+ /+ 2+ - 1+ / 2+ 8
7
% + -+ + + /+ 2+ - 0+ / +
EXPECTED

6
% + -+ + 2+ 0+ 1 ++ - -+ / +
5
% " 4
3
&' +- +2 / 2 -- / 2
1
() ! * +1 + 0 2 -- / 0
0 5 10
M22
+, + +0 + +/ + ++ + +1 + ++
+, - 2/ / / + 01 + / + ++

# # $

"
RBC LOW RANGE LINEARITY
! ! " # # "# # ## 6
% + 1 +1 + 2/ / 0 1 5
EXPECTED

% + 1 +1 + 20 2 1 /0
4
% + - +1 + 20 + 1 1 /0
% + 1 + 1/ + 2- 1 + 1 /1 3
% " 2
1
&' + 1 +1 + 20 / + 1 //
0
() ! * + 1 +1 + 2- 1 1 // 0 2 M22 4 6

+, + ++ + ++ ++ ++ + +1 + ++
+, / + 0 +0 +0 + ++

0
 % # % # $

"
! ! " # # "# # ##
PLT LOW RANGE LINEARITY
% 0 1 1 1 300
% 2 -1 - // 11 250
% - / -/ + -+

EXPECTED
200
% + - // -
% " 150

100
&' 2 -0 + 1/
50

() ! * - 12 1 / 1/ 0
0 100 M22 200 300
+, 0/ 02 / ++
-
+, - 1 / 00 1 - + ++

& # & #
$
"
! ! " # # "# # ##
HGB LOW RANGE LINEARITY
% + 1+ + + 0 ++ 1+ ++ 14
% + 1+ ++ + 0 ++ + + 12
% + + ++ + - /+ 1+ 2+
EXPECTED

10
% + 1+ ++ + - 2+ + +
8
% "
6
&' +1 + -2 + 4
2
() ! * +0 1 0+ 1 + 0
0 5 M22 10 15
+, + + / + / + +/ + +2 + ++
+, / 1 02 ++

/
III. CARRYOVER STUDY
) ! # " " ) !
% & $ '
( # # ! *

−
= ×
−

& ! # 5'

$ '
()

01 1 /1
,
'2 10 10 22
,
'2 1- 0 - 2
,
'2 10 2 1+ 1 22
3 + ++ +
3 + + ++ 0 +
3 + + ++ +

&&
4 & #. - #.
## #.
# #.
##
IV. REPEATABILITY TEST
& ) # ) ! # " ! # !) '&
) ! ! '( ) ! 8 9 89 :
5 '

& ) # ! ) ! " # '

* !

5 /
01 ; - < 0 += + !!
;- < -5
; + < /5
6 ; < -+ 5
; + < -5
1 ; 1+ < 5
1 ; < 1 += +0 !!
/1 ; - < +"
; < 1+ + 5
5 ; < -
+0 ; < 1
;- < -+= + !!
5 ; <

& # '

01 6 1 1 /1 5 +0 5
0 1 2- - 0 2 1 1- -/ 1+ / 2 - 1 0/ 2
- - 21 -- 1 +/ 1- -/ 1 2 11 + 2
-2 +- - - + 1 12 -/ 1 2 - / /0 2
-2 2- - 0 +2 1 -0 -/ 1 / 2 - 1 /- 2
0 2 -1 2 1 + 1- -0 1 1 2 1 02
- 2 -- +- 1- -0 1 2 1 2
0 2 -0 0 + 1- -0 1 2 0 / +/ 2
-2 1 2 -1 0 / + 1 -- -/ 1 0 2 1 2 2
0 - 2 -1 1 1 +/ 1 -1 -0 1 1 2 1- 2 2
0 1 2- -1 +/ 1 -1 -/ 1 1 2 1 /0 2
-2 0 2 -0 - +/ 1 12 -0 1 2 1 1 2
0 0 -0 - 2 + 1 10 -/ 1+ / 2 1 / 2
0 1 21 - - / +0 1 -1 -/ 1 2 1 /- 2

. $. " . . #. .
" ". . $ . -# $
8&9 + +- + + ++ + + + + +
5 . . " . .
- .
- #.
- #. #. #. .
$ .
- .

2
V. CORRELATIONS
& !) ) ! '

& ) ! # !) 3 % + # >#7 '

( / ! # ! !) '

& "*

WBC HGB
30
25
25
20
20
15
M22

M22
15
10
10
y = 0,9791x + 0,21
y = 0,9195x + 0,6222 5
5 R2 = 0,9941
R2 = 0,9945
0
0
0 5 10 15 20 25
0 10 20 30 40
P120 P120

RBC HT
60
7,00
6,00 50
5,00 40
4,00
30
M22

3,00
20
2,00
y = 0,9356x + 0,2301 y = 0,8501x + 5,3347
1,00 10
2
R = 0,9837 R 2 = 0,9721
0,00 0
0,00 2,00 4,00 6,00 8,00 0 20 40 60 80
P 12 0 P120

+
 MCV PLT
140 1000
120 900
800
100
700
80 600
M22

M22
500
60
400
40 300
y = 0,9631x + 3,5265 200
20 y = 0,9083x + 18,194
R2 = 0,8982 100
0 R 2 = 0,9811
0
0 50 100 150
0 200 400 600 800 1000
P120 P120

MPV
12

10

8
M22

4
y = 0,8015x + 1,7543
2
R 2 = 0,8085
0
0 5 P120 10 15

$ "$ " "

+

9 " ,- 9?
(( '&
) (" 0'

WBC LYM
30 60

25 50

20 40
M22
M22

15 30

10 20
y = 0,9195x + 0,6222 y = 1,009x - 0,2862
5 10
R2 = 0,9945 R 2 = 0,9788

0 0
0 10 20 30 40 0 20 40 60
P120 P120
 MON EOS
20 14
18 12
16
14 10
12 8
M22

M22
10
8 6
6 4
y = 0,9377x + 0,4536
4 R 2 = 0,876 y = 0,8402x + 0,1817
2 2
R 2 = 0,9031
0 0
0 5 10 15 20 0 5 10 15
P120 P120

NEU BAS
100 3,5
90 y = 0,4447x + 0,7282
3 R 2 = 0,035
80
70 2,5
60 2
M22

M22

50
40 1,5
30 1
20
y = 0,9878x + 0,5612 0,5
10
0 R2 = 0,9768
0
0 20 40 60 80 100 0 0,5 1 1,5 2
P120 P120

$ " ,-./
00 " "
+

& ) ! 7 # '

"
" " $

1
01 7 # 899 : / + 2 2- +0 + 22/
7 : ++2 ,+ 0 +2 2
7 : + 2 // + 1- 0 +2 -
67 : +2 / + -0 +2
7 : + 1+ + / + 2-
1 7 : + 111/ +/ 0 + /
1 7 # 899 : / + 2 -0 + + + 22
/1 7'8* : / + 2/2 + + 22/
7 : / + -+ - 1/ +2 1
57 : / + 20 0 0- + 21/
7 # 899 : / + 2+ 21 + 22
57 : / + + - /-1 + 2
> ) ! !) 3 ,/-+
@! ? ''( 20 ! # ! !)
'

& "*

WBC HT
70 60

60 50

50 40

M22-576
M22-576

40 30
30
20
20 y = 1,0247x - 0,2032
R2 = 0,9966 y = 1,0238x + 0,4471
10
10 R2 = 0,9724
0
0
0 10 20 30 40 50
0 20 40 60
BCI
BCI

RBC MPV
7 14

6 12
5 10
M22-576

M22-576

4 8
3
6
2 y = 1,0194x - 0,0594
y = 0,5816x +3,9007
R2 = 0,9762 4
1 R2 = 0,5358
2
0
0 2 4 6 8 0
0 5 10 15
BCI
BCI

HGB RDW
25
18
16
20
14
12
M 22-576
M22-576

15
10
8
10
6
y = 0,9683x + 0,21
4 y = 0,622x + 5,5612
R 2 = 0,977 5
R2 = 0,7656
2
0 0
0 5 10 15 20 0 5 10 15 20 25 30

BCI BCI
 MCV PLT
140 800
120 700
100 600
500
M22-576

M22-576
80
400
60
300
y = 1,0369x + 0,2582
40 y = 0,9319x + 10,833
R2 = 0,9335 200
20 R2 = 0,9827
100
0 0
0 50 100 150 0 200 400 600 800
BCI BCI

$ " " "

1-

9 " ,- 9?
(( '&
) (" '

WBC MON
70 35
60 30
50 25
M22-576
M22-576

40 20
30 15

20 10
y = 1,0247x - 0,2032 y = 0,9511x + 1,2602
10 5
R2 = 0,9966 R2 = 0,9685
0 0
0 20 40 60 0 10 20 30 40

BCI BCI

LYM NEU
80 120
70
100
60
80
50
M22-576

M22-576

40 60
30
y = 0,9871x + 1,0463 40
20
R2 = 0,994 y = 0,9806x + 0,1361
10 20
R2 = 0,992
0 0
0 20 40 60 80 0 50 100 150
BCI BCI

1
 EOS BAS
30 1,6
1,4
25
1,2
20 1

M22-576
M22-576

15 0,8
0,6
10 y = 0,3396x +0,2059
y = 0,8026x +0,0208
0,4 R2 = 0,2279
5 R2 = 0,9838 0,2
0 0
0 10 20 30 40 0 1 2 3 4 5
BCI BCI

$ " ,-./
00 " "
1-

-
VI. STABILITY TESTS
", ! # 1 !) 1A A '& !)
'

& 7 " *

0
 10 60

9,5

9
8,5
50
8

N EU %
WBC

7,5
7
40
6,5

6
5,5

5 30
Day 0 Day +1 Day +2 Day 0 Day +1 Day +2

Day Day

60 10

9
55
8

7
50
6
EO S %
L ym %

45 5
4
40
3

2
35
1
30 0
Day 0 Day +1 Day +2 Day 0 Day +1 Day +2

Day Day

10 5

8 4
7

6 3
MO N %

BAS %

4 2

2 1

0 0
Day 0 Day +1 Day +2 Day 0 Day +1 Day +2

Day Day

, ! "! 23 43

/
VII. MORPHOLOGIC ABNORMALITY FLAGGING
EFFICIENCY
& ! ) " # ! "" " 3 +-
!) ) ! !) /-+ @! ? ''? !
) # # # ! !)
!! -,) 9 ! '

> # ! *

, & % &% *8 !) ) # ! '

, & B" &B *8 !) " # ! '
, ( % (% *8 !) " # "" # 3 '
, ( B" (B *8 !) % # "" # 3 '

& ) ! *

= ×
+

= ×
+

+
= ×
+ + +

& " # *

4 2,
!
8 !) !# +-
% 8 !)
&B *& B" +1
&% *& % /+
(B *( B"
(% *( % 2

,,! ,,,47 : - 5
,,! ) !,,!,47 : 105
,!, !47 : 125

& *,
!, 5 %
B" 2/5
% / /5