Bio-Rad Bio-Plex System Validation and Calibration Tools User Manual
Page 11
3.
If the control numbers on the BizCard CD already exist in the database, you
will receive the message that the control numbers are already installed and
the program will exit. Click on the OK button and remove the BizCard CD.
4.
If the control numbers on the BizCard CD are not found in the database, you
will see a dialog asking you to press OK to install the control numbers with
their specifications. Click on the OK button.
5.
A dialog box will appear informing you that control numbers installation is
complete. You may now proceed with validation in Bio-Plex Manager using
the current control number.
Section 10
Procedure for Performing Validation
Introduction
This section provides instructions for use of the Bio-Plex
®
validation kit 4.0 using
either Bio-Plex Manager™ 4.0/4.1 software with MCV plate III or Bio-Plex
Manager 5.0 and later with MCV plate IV. Either software version provides a fully
automated validation routine that sequentially performs all the validation tests
without further user intervention. To perform all validations in a single step, follow
instructions in Section 10.1. If you wish to perform an individual validation routine,
consult Sections 10.2–10.5.
N
No
otte
e:: IIn
n tth
he
e ffo
ollllo
ow
wiin
ng
g iin
ns
sttrru
uc
cttiio
on
ns
s a
allll rre
effe
erre
en
nc
ce
es
s tto
o tth
he
e M
MC
CV
V p
plla
atte
e w
wiitth
ho
ou
utt
s
sp
pe
ec
ciiffy
yiin
ng
g IIIIII o
orr IIV
V iin
nd
diic
ca
atte
e tth
he
e p
prro
oc
ce
ed
du
urre
e iis
s u
us
se
ed
d ffo
orr e
eiitth
he
err c
co
on
nffiig
gu
urra
attiio
on
n.. A
Allll
p
piic
cttu
urre
es
s a
arre
e u
up
pd
da
atte
ed
d tto
o rre
efflle
ec
ctt tth
he
e n
ne
ew
we
es
stt M
MC
CV
V p
plla
atte
e,, b
bu
utt d
do
oe
es
s n
no
ott iim
mp
plly
y tth
ha
att
tth
he
erre
e iis
s a
an
ny
y d
diiffffe
erre
en
nc
ce
e iin
n p
pe
errffo
orrm
ma
an
nc
ce
e..
10.1 One-Step Procedure for all Validation Parameters
Procedure
1.
Turn on the Bio-Plex array reader, microplate platform, and computer as
specified in the Bio-Plex hardware and Bio-Plex Manager user manuals.
2.
Perform start-up procedure as directed.
3.
Calibrate Bio-Plex array reader using Cal1 and Cal2 beads found in the
Bio-Plex calibration kit according to the Bio-Plex Manager software manual.
N
No
otte
e:: B
Be
e s
su
urre
e tto
o c
ca
alliib
brra
atte
e iim
mm
me
ed
diia
atte
elly
y b
be
effo
orre
e v
va
alliid
da
attiio
on
n.. IIff y
yo
ou
u a
arre
e u
us
siin
ng
g B
Biio
o--P
Plle
ex
x
M
Ma
an
na
ag
ge
err 4
4..0
0//4
4..1
1,, u
us
se
e e
eiitth
he
err tth
he
e h
hiig
gh
h o
orr llo
ow
w R
RP
P1
1 tta
arrg
ge
ett ffo
orr C
Ca
all2
2 c
ca
alliib
brra
attiio
on
n
d
de
ep
pe
en
nd
diin
ng
g o
on
n tth
he
e tty
yp
pe
e o
off a
as
ss
sa
ay
y b
be
eiin
ng
g p
pe
errffo
orrm
me
ed
d.. IIff y
yo
ou
u a
arre
e u
us
siin
ng
g B
Biio
o--P
Plle
ex
x
M
Ma
an
na
ag
ge
err 5
5..0
0,, tth
he
e c
ca
alliib
brra
attiio
on
n iis
s d
do
on
ne
e o
on
n llo
ow
w R
RP
P1
1 tta
arrg
ge
ett.. S
Se
elle
ec
cttiio
on
n o
off h
hiig
gh
h R
RP
P1
1
tta
arrg
ge
ett iis
s d
do
on
ne
e iin
n tth
he
e v
va
alliid
da
attiio
on
n s
sc
crre
ee
en
n..
4.
Remove all validation bead sets from 4°C storage and vortex each bottle for
30 sec. This is very important for proper validation.
9
4110185B.qxp 9/25/2007 11:55 AM Page 9