MICROPOINT qLabs QSV-1-CL Pro User manual

INTENDED USE
Micropoint Biotechnologies, Inc. has optional
liquid controls for qLabs®Vet Coag Panel 2
system. The qLabs®Vet Coag Panel 2 Liquid
Controls are used with qLabs®Vet Coag
Panel 2 Test Strips to verify the qLabs®Vet
Coag Panel 2 system performance. It is
recommended that two levels of liquid controls
are used to perform the test.
WARNING AND PRECAUTIONS
1. For in vitro diagnostics use only. Do not
take internally.
2. Read the instructions carefully before using.
Deviations from the described procedure
may alter performance.
3. Take all necessary precautions required
when handling laboratory reagents.
4. Do not freeze liquid controls.
5. Do not use expired liquid controls.
6. Do not use for any purpose other than
described in the “Intended Use” section.
7. Do not interchange caps as contamination
may occur and compromise results.
qLabs®Vet Coag Panel 2 Liquid Control
For Health Care Professional Use Only
qLabs®Vet Coag Panel 2 Liquid Control Kit Specication / Order Information
REF Quantity Name Storage
QSV-1-CL Pro
2 x 1 ml qLabs®Vet Coag Panel 2 Liquid Control Level 1
(For Professional Use Only ) 18-30 oC
2 x 1 ml qLabs®Vet Coag Panel 2 Liquid Control Level 2
(For Professional Use Only) 18-30 oC

8. Refer to local biohazard procedures for safe
waste disposal.
REAGENTS
Each control contains varied levels of
electrolytes, coagulation factors, stabilizers
and preservatives. The PT and APTT values of
qLabs®liquid controls are lot-specic.
CONTROL STORAGE AND STABILITY
• Unopened controls are stable at 18-30 °C
until expiration date stated on the label.
• Once opened, controls are stable for 15
days if capped tightly at 18-30 °C.
• Before sampling, gently swirl the vial several
times to ensure homogeneity.
Do not freeze. Do not expose to
excessive heat.
TESTING PROCEDURES
1. Gather materials.
• qLabs®Vet
• qLabs®Vet User’s Manual
• qLabs®Vet Coag Panel 2 Test Strip
• qLabs®Vet Coag Panel 2 Liquid Control:
Level 1 and Level 2
Note: Please refer to the user’s manual for
appropriate operation instructions about the
test strip and the meter.
2. Insert the strip.
• Press the power button for 2 seconds to
turn on the qLabs®Vet.
• Remove a new qLabs®Vet Coag Panel 2
Test Strip from foil pouch.
• Insert the strip, electrode end rst, into the
test strip guide.
3. Choose QC Test item.
Use arrow button to choose QC test, then
press OK.
4. Enter the code and lot number of the
control.
If the code and lot number match with
those on the label of control vials, simply
press the “OK” button. If not match, two
methods are available for the user to input
the required information. Either use the left
arrow button to select the “PEN” symbol
to input manually or use the right arrow

button to select the “BarCode” symbol to
input with the built-in barcode scanner.
Please refer to the user manual for more
information.
5.Conrm the code and lot number of the
control.
Press “OK” button to conrm the code
and lot number of the control. Once the
lot number is entered, the meter will
automatically check whether the control
is expired. If the control is expired, the
user shall use another control within the
expiration period to perform the test.
Note:Always match the control code, lot
number on the display with those on the
control vials. Failure to do so may cause
inaccurate results.
6. Enter the code and lot number of the strip.
Use the same method as indicated in step
4 to enter the code and lot number of the
strip printed on the label of the foil pouch.
7. Conrm the code and lot number of the
strip.
Press “OK” button to conrm the code
and lot number of the strip. Once the lot
number of strip is entered, the meter will
automatically check whether the strip is
expired or not. If the strip is expired, the
user shall use another strip within the
expiration period to perform the test.
Note: Always match the strip code, lot
number on the display with those on the
label of strip. Failure to do so may cause
unacceptable results.
8. After conrming the code and lot number
of the strip, the meter will warm up
automatically for the test. When it is ready
to perform a test, the meter will beep and
prompt the user to apply control sample.
9. Perform the control test.
Before using, slightly swirl the target
control at least 10 times and then apply
one drop of the liquid control to the
sample well, the system will start test
automatically.

Do not add more than one drop of
liquid control.
The QC test result will appear as PT and
APTT value, along with test date, name
and time in approximately 1 minute.
APTT
32.3
03/09/15 10.05
.
143.6
PTC2
Note: The result interface may be different,
depending on the software conguration.
10.Finish the test.
Remove the used test strip after the test is
completed. Dispose of the used test strip
in compliance with the local biohazard
regulations.
Insert a new test strip and repeat the above
procedures to perform the next level liquid
control test.
EXPECTED RESULTS
The system is working properly and all testing
procedure has been done correctly when the
test results obtained fall within the assigned
control PT and APTT range on the vial.
Note: Please refer to the assigned PT and
APTT control range printed on the label of
the vial.
UNEXPECTED RESULTS
If the test results fall outside of the assigned
range or qLabs®ElectroMeter displays error
code “E XXX”, check for the following:
1. Controls may be expired and stored
improperly.
2. The user may not be doing the test
correctly. Insert a new test strip and repeat
the test procedure to perform a new test.
3. If the user follow all guidelines and the
results are still unacceptable, please
contact the local distributor or call
Micropoint Biotechnologies, Inc. technical
support at [phone].

PERFORMANCE CHARACTERISTICS
Within-Run
(N=20)
PT Value
Mean S.D. %CV
Level 1 17.36 0.39 2.23
Level 2 31.60 0.96 3.04
Between-
Run (N=40)
PT Value
Mean S.D. %CV
Level 1 17.49 0.48 2.76
Level 2 31.97 1.12 3.49
Within-Run
(N=20)
APTT Value
Mean S.D. %CV
Level 1 113.03 4.35 3.85
Level 2 144.41 4.53 3.14
Between-
Run (N=40)
APTT Value
Mean S.D. %CV
Level 1 115.48 3.86 3.34
Level 2 143.80 7.03 4.89
ADDITIONAL INFORMATION
For additional information about this product,
please call your local distributor or call our
customer service at [phone].

Symbols Explanation
In Vitro Diagnostics
Name and Address of Manufacturer
Temperature Limitation
Lot Number
Expiry Date
Catalogue Number
Catains Sufficient for n Tests
Caution. Read Carefully.

Micropoint Biotechnologies, Inc.
6F, No.3, Industry 5 Road
Shekou, Shenzhen, Guangdong
China, 518067
www.micropointbio.com
Tel [phone]
Fax [phone]
Obelis SA
Bd. General Wahis, 53
1030 Brussels
Belgium
www.obelis.net
Tel [phone]
Fax [phone]
©2015 Micropoint Biotechnologies, Inc.
All rights reserved. Specications are subject to
change without notice. Printed in China.
qLabs®and Micropoint®are registered
trademarks of Micropoint Bioscience, Inc.
P/N 99030545431 Rev. A1