522330 - RNA Medical

Transcription

522330 - RNA Medical
star
star
M2
Key 29
M1
Y
M
C
K
GRAY
75
CVC 223
Level 5
M
Y
Key 28
M1
M2
CVC 223 CO-Oximeter Calibration Verification Controls
2017-04
C
55226
CVC 223 CO-Oximeter Calibration Verification Controls
tHb
g/dL
O2Hb
%
COHb
%
MetHb
%
Set: 522330
IL
mean
M
C
Synthesis Series
GEM OPL
75
682
GEM 4000
75
range
DNA2
20.7
19.2
21.3
20.3
482
K
Y
Key 27
M2
M1
75
75
K
Expected Values Chart
Analyzers
mean
18.7 - 22.7
17.2 - 21.2
19.1 - 23.5
18.3 - 22.3
range
mean
DNA2
1.6
–0.9 - 4.1
3.8
1.3 - 6.3
0.8 –7.2 - 8.8
2.4 –0.1 - 4.9
range
mean
DNA2
97.4
92.4 - 102.4
95.8 90.8 - 100.8
ORL1
95.8 90.8 - 100.8
DNA2
0.5
0.0
0.5
0.1
range
–1.5 - 2.5
–2.0 - 2.0
–2.4 - 3.4
–1.9 - 2.1
M2
Key 26
M1
C
OSM 3
GRAY
Radiometer
K
CCX
75
ABL 500 Series
M2
ABL 600 Series
ABL 80 Series
ABL 800 Series
M
Y
Key 25
M1
ABL 700 Series
NPT 7
C
–2.1 - 3.7
89.2 - 99.2
0.2
–1.8 - 2.2
PRODUCT DESCRIPTION
93.8
94.8
94.8
93.7
DNA2
93.7
DNA2
88.8
89.8
89.8
88.7
0.7
0.5
0.5
3.3
DNA2
3.3
DNA2
–1.3 - 2.7
–1.5 - 2.5
–1.5 - 2.5
1.3 - 5.3
94.8
92.8
89.8 - 99.8
87.8 - 97.8
0.7
1.2
–1.3 - 2.7
–0.8 - 3.2
3.8
1.3
–4.2 -11.8
–6.7 - 9.3
ORL1
23.8 21.8 - 25.8
4.5
2.0 - 7.0
94.2
21.9
22.1
21.7
19.8
DNA2
19.8
DNA2
4.1
1.6 3.7
1.2 4.1
1.6 2.1 –0.4 DNA2
2.1 –0.4 DNA2
23.9
24.1
23.7
21.8
17.8 - 21.8
6.6
6.2
6.6
4.6
4.6
-
98.8
99.8
99.8
98.7
88.7 - 98.7
CVC 223 is provided in five (5) distinct levels of total hemoglobin,
oxyhemoglobin, and carboxyhemoglobin covering the physiologically
significant range of instrument performance. It also contains methemoglobin.
CVC 223 is packaged in sealed glass ampuls, each containing 1.2 mL of
solution. Ampuls are packaged in kits containing four (4) ampuls of each level.
1.3 - 5.3
K
Roche
20.4 18.4 - 22.4
20.4 18.4 - 22.4
50
Cobas b 221
50
OMNI Series
2.2
3.1
–0.3 - 4.7
0.6 - 5.6
M2
21.8 19.8 - 23.8
22.1 20.1 - 24.1
22.3 20.3 - 24.3
M1
Key 24
1200 Series
4.2 - 9.2
3.7 - 8.7
4.2 - 9.2
91.6
92.8
91.6
86.6 - 96.6
87.8 - 97.8
86.6 - 96.6
0.1
0.0
0.1
–1.9 - 2.1
–2.0 - 2.0
–1.9 - 2.1
C
K
50
50
M
Y
Key 23
M1
M2
For Roche OMNI Analyzers:
Create a new file of aqueous QC material in the QC Set-up function. Set the
ranges for the CO-Oximeter parameters as follows:
Analyte
tHb (g/dL)
Hb Derivatives (%)
C
K
GRAY
Consult Instructions for Use
For In Vitro Diagnostic Use
Y
Key 22
M1
M2
50
Catalog Number
Store At
Manufactured For
Use By
K
50
25
M2
Key 21
M1
Y
M
General Instructions for all other CO-Oximeters:
1. Calibrate your CO-Oximeter according to the manufacturer’s recommendations.
If the analyzer is a combination blood gas/CO-Oximetry system, a two-point
calibration is suggested.
2. Beginning with level 1, gently invert the ampul to mix the solution. Tap the
ampul to restore the liquid to the bottom of the ampul.
3. Open the ampul by snapping off the tip at the score. Use the Snapper
provided to protect fingers from cuts.
C
K
25
M2
25
Key 20
High Limit
25.0
110.0
For Siemens (Bayer) 800 Series Analyzers:
Follow steps one (1) through five (5) below under “General Instructions.”
Alternate running human blood samples with the CVC 223 samples. Complete
steps six (6) through eight (8) under “General Instructions.” Verify the analyzer
performance with daily QC. If a shift in the daily QC values for oximetry is
observed, perform the following corrective action:
●
Clean the CO-Ox sample chamber per the maintenance instructions in
section 3 of the Operator's Manual.
●
Verify the performance with QC.
●
If you still see a shift in QC, run a quantity of 10-12 normal human blood
samples through the system (CO-Ox only mode is sufficient).
●
Verify performance with QC.
●
Contact Siemens Technical Support for assistance if the problem persists.
RNA Medical, Division of Bionostics, Inc.
7 Jackson Road
Devens, MA 01434 USA
978-772-9070 ● 800-533-6162
www.RNAMedical.com
M1
Low Limit
0.0
-10.0
Run the CVC 223 samples as a QC sample in the new file, following steps one
(1) through eight (8) below under “General Instructions.”
C
M
Lot Number
Y
EXPECTED VALUES
It is best to run CVC 223 in the same manner as patient samples, however,
please refer to any specific instructions for your analyzer regarding the use of
these or any other control materials.
INSTRUMENT MANUFACTURERS
Instrumentation Laboratory, Lexington, MA
International Technidyne Corporation, Edison, NJ
Nova Biomedical, Waltham, MA
Radiometer America, Westlake, OH
Roche Diagnostics, Indianapolis, IN
Siemens Healthcare Diagnostics, Deerfield, IL
H1231 Rev. 4/2012
®
4. Introduce the liquid from the ampul to the analyzer. Use direct aspiration,
syringe transfer, or capillary mode techniques.
5. Record the results on the Data Collection and Linearity Worksheet provided
for each analyte.
6. Repeat steps 2 through 5 for the remaining ampuls of level 1 until three
(3) replicates are completed. (A fourth ampul of each level is provided in
the event of accidental breakage or obvious sampling error.) Test levels 2,
3, 4, and 5 the same way. Record all values on the worksheets.
7. Calculate the mean value for each test analyte and compare your mean to
the range on the Expected Values Chart. If your mean is within the range,
circle "Y" at the question “OK?” If your mean is outside the range, circle "N"
and take corrective action.
8. To graph the linearity of your results:
a) Using the graph area provided, plot the Test Value (mean) against the
Expected Value.
b) Connect the plotted points to visualize linearity.
STORAGE
CVC 223 should be analyzed immediately after removal from refrigeration.
FOOTNOTES:
1. ORL - Outside Reportable Limits of Analyzer
2. DNA - Data Not Available at time of printing
CVC 223
2017-05
2017-04
2017-04
2017-04
2017-04
Note: Steps 7 and 8 may be performed on-line as a feature of PeerQC®
described below.
DIRECTIONS FOR USE
M
Y
800 Series
6.7
6.2
6.7
Level 1:
Level 2:
Level 3:
Level 4:
Level 5:
Active Ingredients:
CVC 223 is a purified bovine hemoglobin solution that has been saturated with
carbon monoxide or treated with precise concentrations of carbon monoxide.
This control contains no preservatives and no human-based materials. It is
considered good laboratory practice to follow the recommended "Universal
Precautions" when handling any blood product.
The expiration date stated on the CVC 223 packaging is for product stored at
2-8 °C. Avoid exposure to freezing and temperatures greater than 8 °C.
Siemens (Bayer)
400 Series
Set: 2017-04
0.8
21.4 19.2 - 23.6
21.2 19.0 - 23.4
19.9 20.1 19.7 17.8 -
55127
54851
54947
55042
55226
RNA Medical® Brand CVC 223 CO-Oximeter Calibration Verification Controls
are assayed materials used for confirming the calibration and linearity of total
hemoglobin and hemoglobin fractions on CO-Oximeter analyzers.
Nova
M
Y
AVOXimeter 4000
Level 1:
Level 2:
Level 3:
Level 4:
Level 5:
INTENDED USE
ITC
AVOXimeter 1000E
5 Levels
The values for each control analyte on the enclosed Expected Values Chart are
based on multiple determinations performed on randomly selected samples
from each lot. The listing for each instrument represents the expected range
and mean value of this range.
The Expected Values are provided as a guide in evaluating analyzer
performance. Since instrument design and operating conditions may vary,
each laboratory should establish its own acceptance criteria.
STATISTICAL SUPPORT
RNA Medical PeerQC, available at www.RNAMedical.com, features webbased graphing and reporting for its Calibration Verification Controls and is
available at no charge to RNA Medical customers. The graphing steps outlined
above may be performed on-line as a feature of this service. Please contact
RNA Medical or visit our website for information about utilizing PeerQC for this
product.
LIMITATIONS
1. Extended exposure to temperatures greater than 8 °C will affect product
performance. If CVC 223 has turned brown in color, this change indicates
deterioration and the formation of methemoglobin. In such a case, the
control is not suitable for use and should be discarded.
2. The methemoglobin in this control can confirm product storage temperature
integrity as well as the performance of the MetHb channel on COOximeters. Because of its limited range of values, it will not be of significant
value in determining linearity, calibration verification, and reportable range
for MetHb.
3. CVC 223 is sensitive to many instrument related factors that would affect
analytical results. It is a bovine blood-based material but does not contain
red cells. Therefore, it may not detect certain malfunctions that would affect
the testing of human blood.
4. This product is intended for use as a quality control material and can assist
in evaluating the performance of laboratory instruments. It is not for use as
a calibration standard and its use should not replace other aspects of a
complete quality control program.
RNA Medical is a registered trademark and PeerQC is a registered service mark of Bionostics, Inc.
®
GRAY
K
C
M
4
M
Level 5
2017-04
CVC 223 CO-Oximeter Calibration Verification Controls
Expected Values Chart
C
K
mean
O2Hb
%
range
mean
COHb
%
range
mean
MetHb
%
range
mean
Set: 522330
range
IL
DNA2
20.7
19.2
21.3
20.3
482
682
Synthesis Series
P
GEM OPL
M+C
GEM 4000
18.7 - 22.7
17.2 - 21.2
19.1 - 23.5
18.3 - 22.3
DNA2
1.6
–0.9 - 4.1
3.8
1.3 - 6.3
0.8 –7.2 - 8.8
2.4 –0.1 - 4.9
DNA2
97.4
92.4 - 102.4
95.8 90.8 - 100.8
ORL1
95.8 90.8 - 100.8
DNA2
0.5
0.0
0.5
0.1
–1.5 - 2.5
–2.0 - 2.0
–2.4 - 3.4
–1.9 - 2.1
M2
Y
Key 17
M1
AVOXimeter 1000E
AVOXimeter 4000
M
C
K
ABL 600 Series
ABL 700 Series
M
ABL 80 Series
ABL 800 Series
C
Y
Key 16
M2
GRAY
Y+C
ABL 500 Series
M1
OSM 3
–2.1 - 3.7
89.2 - 99.2
0.2
–1.8 - 2.2
PRODUCT DESCRIPTION
93.8
94.8
94.8
93.7
DNA2
93.7
DNA2
88.8
89.8
89.8
88.7
0.7
0.5
0.5
3.3
DNA2
3.3
DNA2
–1.3 - 2.7
–1.5 - 2.5
–1.5 - 2.5
1.3 - 5.3
94.8
92.8
89.8 - 99.8
87.8 - 97.8
0.7
1.2
–1.3 - 2.7
–0.8 - 3.2
3.8
1.3
–4.2 -11.8
–6.7 - 9.3
ORL1
23.8 21.8 - 25.8
4.5
2.0 - 7.0
94.2
21.9
22.1
21.7
19.8
DNA2
19.8
DNA2
4.1
1.6 3.7
1.2 4.1
1.6 2.1 –0.4 DNA2
2.1 –0.4 DNA2
NPT 7
23.9
24.1
23.7
21.8
17.8 - 21.8
6.6
6.2
6.6
4.6
4.6
-
98.8
99.8
99.8
98.7
88.7 - 98.7
CVC 223 is provided in five (5) distinct levels of total hemoglobin,
oxyhemoglobin, and carboxyhemoglobin covering the physiologically
significant range of instrument performance. It also contains methemoglobin.
CVC 223 is packaged in sealed glass ampuls, each containing 1.2 mL of
solution. Ampuls are packaged in kits containing four (4) ampuls of each level.
1.3 - 5.3
Y+M
K
Roche
20.4 18.4 - 22.4
20.4 18.4 - 22.4
Cobas b 221
3
4
OMNI Series
2.2
3.1
–0.3 - 4.7
0.6 - 5.6
M2
Key 15
M1
Y
21.8 19.8 - 23.8
22.1 20.1 - 24.1
22.3 20.3 - 24.3
800 Series
4.2 - 9.2
3.7 - 8.7
4.2 - 9.2
91.6
92.8
91.6
86.6 - 96.6
87.8 - 97.8
86.6 - 96.6
0.1
0.0
0.1
–1.9 - 2.1
–2.0 - 2.0
–1.9 - 2.1
K
4
3
4
3
1/2/3/4 Y 1/2/3/4 M1
1
2
1
2
M2
Key 14
M1
For Roche OMNI Analyzers:
Create a new file of aqueous QC material in the QC Set-up function. Set the
ranges for the CO-Oximeter parameters as follows:
Analyte
tHb (g/dL)
Hb Derivatives (%)
Low Limit
0.0
-10.0
High Limit
25.0
110.0
C
M
Y
EXPECTED VALUES
It is best to run CVC 223 in the same manner as patient samples, however,
please refer to any specific instructions for your analyzer regarding the use of
these or any other control materials.
K
GRAY
4
3
Consult Instructions for Use
For In Vitro Diagnostic Use
M
Y
Key 13
M1
M2
1/2/3/4 M
1
2
Catalog Number
Lot Number
Store At
For Siemens (Bayer) 800 Series Analyzers:
Follow steps one (1) through five (5) below under “General Instructions.”
Alternate running human blood samples with the CVC 223 samples. Complete
steps six (6) through eight (8) under “General Instructions.” Verify the analyzer
performance with daily QC. If a shift in the daily QC values for oximetry is
observed, perform the following corrective action:
●
Clean the CO-Ox sample chamber per the maintenance instructions in
section 3 of the Operator's Manual.
●
Verify the performance with QC.
●
If you still see a shift in QC, run a quantity of 10-12 normal human blood
samples through the system (CO-Ox only mode is sufficient).
●
Verify performance with QC.
●
Contact Siemens Technical Support for assistance if the problem persists.
Use By
3
3
Key 12
General Instructions for all other CO-Oximeters:
1. Calibrate your CO-Oximeter according to the manufacturer’s recommendations.
If the analyzer is a combination blood gas/CO-Oximetry system, a two-point
calibration is suggested.
2. Beginning with level 1, gently invert the ampul to mix the solution. Tap the
ampul to restore the liquid to the bottom of the ampul.
3. Open the ampul by snapping off the tip at the score. Use the Snapper
provided to protect fingers from cuts.
C
M
Y
M1
M2
4
4
1/2/3/4 C
1
2
1/2/3/4 K
1
2
K
C
Manufactured For
Run the CVC 223 samples as a QC sample in the new file, following steps one
(1) through eight (8) below under “General Instructions.”
INSTRUMENT MANUFACTURERS
Instrumentation Laboratory, Lexington, MA
International Technidyne Corporation, Edison, NJ
Nova Biomedical, Waltham, MA
Radiometer America, Westlake, OH
Roche Diagnostics, Indianapolis, IN
Siemens Healthcare Diagnostics, Deerfield, IL
Key 11
H1231 Rev. 4/2012
®
The values for each control analyte on the enclosed Expected Values Chart are
based on multiple determinations performed on randomly selected samples
from each lot. The listing for each instrument represents the expected range
and mean value of this range.
The Expected Values are provided as a guide in evaluating analyzer
performance. Since instrument design and operating conditions may vary,
each laboratory should establish its own acceptance criteria.
STATISTICAL SUPPORT
RNA Medical PeerQC, available at www.RNAMedical.com, features webbased graphing and reporting for its Calibration Verification Controls and is
available at no charge to RNA Medical customers. The graphing steps outlined
above may be performed on-line as a feature of this service. Please contact
RNA Medical or visit our website for information about utilizing PeerQC for this
product.
LIMITATIONS
1. Extended exposure to temperatures greater than 8 °C will affect product
performance. If CVC 223 has turned brown in color, this change indicates
deterioration and the formation of methemoglobin. In such a case, the
control is not suitable for use and should be discarded.
2. The methemoglobin in this control can confirm product storage temperature
integrity as well as the performance of the MetHb channel on COOximeters. Because of its limited range of values, it will not be of significant
value in determining linearity, calibration verification, and reportable range
for MetHb.
3. CVC 223 is sensitive to many instrument related factors that would affect
analytical results. It is a bovine blood-based material but does not contain
red cells. Therefore, it may not detect certain malfunctions that would affect
the testing of human blood.
4. This product is intended for use as a quality control material and can assist
in evaluating the performance of laboratory instruments. It is not for use as
a calibration standard and its use should not replace other aspects of a
complete quality control program.
RNA Medical is a registered trademark and PeerQC is a registered service mark of Bionostics, Inc.
®
M
Y
M1
M2
75
75
K
RNA Medical, Division of Bionostics, Inc.
7 Jackson Road
Devens, MA 01434 USA
978-772-9070 ● 800-533-6162
www.RNAMedical.com
4. Introduce the liquid from the ampul to the analyzer. Use direct aspiration,
syringe transfer, or capillary mode techniques.
5. Record the results on the Data Collection and Linearity Worksheet provided
for each analyte.
6. Repeat steps 2 through 5 for the remaining ampuls of level 1 until three
(3) replicates are completed. (A fourth ampul of each level is provided in
the event of accidental breakage or obvious sampling error.) Test levels 2,
3, 4, and 5 the same way. Record all values on the worksheets.
7. Calculate the mean value for each test analyte and compare your mean to
the range on the Expected Values Chart. If your mean is within the range,
circle "Y" at the question “OK?” If your mean is outside the range, circle "N"
and take corrective action.
8. To graph the linearity of your results:
a) Using the graph area provided, plot the Test Value (mean) against the
Expected Value.
b) Connect the plotted points to visualize linearity.
STORAGE
CVC 223 should be analyzed immediately after removal from refrigeration.
FOOTNOTES:
1. ORL - Outside Reportable Limits of Analyzer
2. DNA - Data Not Available at time of printing
CVC 223
2017-05
2017-04
2017-04
2017-04
2017-04
Note: Steps 7 and 8 may be performed on-line as a feature of PeerQC®
described below.
DIRECTIONS FOR USE
C
M
1200 Series
6.7
6.2
6.7
Level 1:
Level 2:
Level 3:
Level 4:
Level 5:
Active Ingredients:
CVC 223 is a purified bovine hemoglobin solution that has been saturated with
carbon monoxide or treated with precise concentrations of carbon monoxide.
This control contains no preservatives and no human-based materials. It is
considered good laboratory practice to follow the recommended "Universal
Precautions" when handling any blood product.
The expiration date stated on the CVC 223 packaging is for product stored at
2-8 °C. Avoid exposure to freezing and temperatures greater than 8 °C.
Siemens (Bayer)
400 Series
Set: 2017-04
0.8
21.4 19.2 - 23.6
21.2 19.0 - 23.4
19.9 20.1 19.7 17.8 -
55127
54851
54947
55042
55226
RNA Medical® Brand CVC 223 CO-Oximeter Calibration Verification Controls
are assayed materials used for confirming the calibration and linearity of total
hemoglobin and hemoglobin fractions on CO-Oximeter analyzers.
Nova
CCX
Level 1:
Level 2:
Level 3:
Level 4:
Level 5:
INTENDED USE
ITC
Radiometer
1/2/3/4 M2
1
2
tHb
g/dL
Analyzers
Komori/GATF
M
Y
Key 18
M1
M2
25
25
Part No. K-40-6(D)
K
C
55226
5 Levels
75
GRAY
K
C
4
Key 10
M
Y
M1
M2
CVC 223
CVC 223 CO-Oximeter Calibration Verification Controls
C
Level 5
2017-04
75
K
55226
CVC 223 CO-Oximeter Calibration Verification Controls
tHb
g/dL
Key 9
mean
DNA2
20.7
19.2
21.3
20.3
C
482
K
682
75
Synthesis Series
M2
GEM OPL
Key 8
AVOXimeter 1000E
AVOXimeter 4000
M
Y
M1
M2
GEM 4000
C
K
CCX
range
mean
range
mean
Set: 522330
range
18.7 - 22.7
17.2 - 21.2
19.1 - 23.5
18.3 - 22.3
DNA2
1.6
–0.9 - 4.1
3.8
1.3 - 6.3
0.8 –7.2 - 8.8
2.4 –0.1 - 4.9
DNA2
97.4
92.4 - 102.4
95.8 90.8 - 100.8
ORL1
95.8 90.8 - 100.8
DNA2
0.5
0.0
0.5
0.1
–1.5 - 2.5
–2.0 - 2.0
–2.4 - 3.4
–1.9 - 2.1
GRAY
M1
OSM 3
ABL 500 Series
–2.1 - 3.7
89.2 - 99.2
0.2
–1.8 - 2.2
PRODUCT DESCRIPTION
93.8
94.8
94.8
93.7
DNA2
93.7
DNA2
88.8
89.8
89.8
88.7
0.7
0.5
0.5
3.3
DNA2
3.3
DNA2
–1.3 - 2.7
–1.5 - 2.5
–1.5 - 2.5
1.3 - 5.3
94.8
92.8
89.8 - 99.8
87.8 - 97.8
0.7
1.2
–1.3 - 2.7
–0.8 - 3.2
–4.2 -11.8
–6.7 - 9.3
ORL1
23.8 21.8 - 25.8
4.5
2.0 - 7.0
94.2
21.9
22.1
21.7
19.8
DNA2
19.8
DNA2
4.1
1.6 3.7
1.2 4.1
1.6 2.1 –0.4 DNA2
2.1 –0.4 DNA2
Key 7
ABL 600 Series
M
C
ABL 700 Series
ABL 800 Series
NPT 7
17.8 - 21.8
6.6
6.2
6.6
4.6
4.6
CVC 223 is provided in five (5) distinct levels of total hemoglobin,
oxyhemoglobin, and carboxyhemoglobin covering the physiologically
significant range of instrument performance. It also contains methemoglobin.
CVC 223 is packaged in sealed glass ampuls, each containing 1.2 mL of
solution. Ampuls are packaged in kits containing four (4) ampuls of each level.
-
98.8
99.8
99.8
98.7
88.7 - 98.7
1.3 - 5.3
Siemens (Bayer)
20.4 18.4 - 22.4
20.4 18.4 - 22.4
21.8 19.8 - 23.8
22.1 20.1 - 24.1
22.3 20.3 - 24.3
800 Series
1200 Series
2.2
3.1
6.7
6.2
6.7
–0.3 - 4.7
0.6 - 5.6
4.2 - 9.2
3.7 - 8.7
4.2 - 9.2
91.6
92.8
91.6
86.6 - 96.6
87.8 - 97.8
86.6 - 96.6
0.1
0.0
0.1
–1.9 - 2.1
–2.0 - 2.0
–1.9 - 2.1
It is best to run CVC 223 in the same manner as patient samples, however,
please refer to any specific instructions for your analyzer regarding the use of
these or any other control materials.
50
50
Key 5
M2
M1
K
C
M
Y
For Roche OMNI Analyzers:
Create a new file of aqueous QC material in the QC Set-up function. Set the
ranges for the CO-Oximeter parameters as follows:
GRAY
25
M2
Key 4
M1
For In Vitro Diagnostic Use
C
M
Y
Consult Instructions for Use
Manufactured For
Store At
25
25
Key 3
M2
M1
Y
C
M
General Instructions for all other CO-Oximeters:
1. Calibrate your CO-Oximeter according to the manufacturer’s recommendations.
If the analyzer is a combination blood gas/CO-Oximetry system, a two-point
calibration is suggested.
2. Beginning with level 1, gently invert the ampul to mix the solution. Tap the
ampul to restore the liquid to the bottom of the ampul.
3. Open the ampul by snapping off the tip at the score. Use the Snapper
provided to protect fingers from cuts.
Key 2
M
Y
M1
M2
25
25
K
RNA Medical, Division of Bionostics, Inc.
7 Jackson Road
Devens, MA 01434 USA
978-772-9070 ● 800-533-6162
www.RNAMedical.com
C
High Limit
25.0
110.0
For Siemens (Bayer) 800 Series Analyzers:
Follow steps one (1) through five (5) below under “General Instructions.”
Alternate running human blood samples with the CVC 223 samples. Complete
steps six (6) through eight (8) under “General Instructions.” Verify the analyzer
performance with daily QC. If a shift in the daily QC values for oximetry is
observed, perform the following corrective action:
●
Clean the CO-Ox sample chamber per the maintenance instructions in
section 3 of the Operator's Manual.
●
Verify the performance with QC.
●
If you still see a shift in QC, run a quantity of 10-12 normal human blood
samples through the system (CO-Ox only mode is sufficient).
●
Verify performance with QC.
●
Contact Siemens Technical Support for assistance if the problem persists.
Use By
®
Low Limit
0.0
-10.0
Run the CVC 223 samples as a QC sample in the new file, following steps one
(1) through eight (8) below under “General Instructions.”
K
Lot Number
H1231 Rev. 4/2012
4. Introduce the liquid from the ampul to the analyzer. Use direct aspiration,
syringe transfer, or capillary mode techniques.
5. Record the results on the Data Collection and Linearity Worksheet provided
for each analyte.
6. Repeat steps 2 through 5 for the remaining ampuls of level 1 until three
(3) replicates are completed. (A fourth ampul of each level is provided in
the event of accidental breakage or obvious sampling error.) Test levels 2,
3, 4, and 5 the same way. Record all values on the worksheets.
7. Calculate the mean value for each test analyte and compare your mean to
the range on the Expected Values Chart. If your mean is within the range,
circle "Y" at the question “OK?” If your mean is outside the range, circle "N"
and take corrective action.
8. To graph the linearity of your results:
a) Using the graph area provided, plot the Test Value (mean) against the
Expected Value.
b) Connect the plotted points to visualize linearity.
EXPECTED VALUES
Analyte
tHb (g/dL)
Hb Derivatives (%)
Catalog Number
The values for each control analyte on the enclosed Expected Values Chart are
based on multiple determinations performed on randomly selected samples
from each lot. The listing for each instrument represents the expected range
and mean value of this range.
The Expected Values are provided as a guide in evaluating analyzer
performance. Since instrument design and operating conditions may vary,
each laboratory should establish its own acceptance criteria.
STATISTICAL SUPPORT
RNA Medical PeerQC, available at www.RNAMedical.com, features webbased graphing and reporting for its Calibration Verification Controls and is
available at no charge to RNA Medical customers. The graphing steps outlined
above may be performed on-line as a feature of this service. Please contact
RNA Medical or visit our website for information about utilizing PeerQC for this
product.
LIMITATIONS
1. Extended exposure to temperatures greater than 8 °C will affect product
performance. If CVC 223 has turned brown in color, this change indicates
deterioration and the formation of methemoglobin. In such a case, the
control is not suitable for use and should be discarded.
2. The methemoglobin in this control can confirm product storage temperature
integrity as well as the performance of the MetHb channel on COOximeters. Because of its limited range of values, it will not be of significant
value in determining linearity, calibration verification, and reportable range
for MetHb.
3. CVC 223 is sensitive to many instrument related factors that would affect
analytical results. It is a bovine blood-based material but does not contain
red cells. Therefore, it may not detect certain malfunctions that would affect
the testing of human blood.
4. This product is intended for use as a quality control material and can assist
in evaluating the performance of laboratory instruments. It is not for use as
a calibration standard and its use should not replace other aspects of a
complete quality control program.
RNA Medical is a registered trademark and PeerQC is a registered service mark of Bionostics, Inc.
®
C
M
Key 1
Y
M1
M2
25
GRAY
K
4
1010750 Bionostics INS01231 Rev. K
K
CVC 223
STORAGE
CVC 223 should be analyzed immediately after removal from refrigeration.
INSTRUMENT MANUFACTURERS
Instrumentation Laboratory, Lexington, MA
International Technidyne Corporation, Edison, NJ
Nova Biomedical, Waltham, MA
Radiometer America, Westlake, OH
Roche Diagnostics, Indianapolis, IN
Siemens Healthcare Diagnostics, Deerfield, IL
2017-05
2017-04
2017-04
2017-04
2017-04
Note: Steps 7 and 8 may be performed on-line as a feature of PeerQC®
described below.
DIRECTIONS FOR USE
FOOTNOTES:
1. ORL - Outside Reportable Limits of Analyzer
2. DNA - Data Not Available at time of printing
Level 1:
Level 2:
Level 3:
Level 4:
Level 5:
Active Ingredients:
CVC 223 is a purified bovine hemoglobin solution that has been saturated with
carbon monoxide or treated with precise concentrations of carbon monoxide.
This control contains no preservatives and no human-based materials. It is
considered good laboratory practice to follow the recommended "Universal
Precautions" when handling any blood product.
The expiration date stated on the CVC 223 packaging is for product stored at
2-8 °C. Avoid exposure to freezing and temperatures greater than 8 °C.
K
M
400 Series
C
Key 6
50
M2
OMNI Series
M1
50
Roche
Cobas b 221
Set: 2017-04
0.8
3.8
1.3
23.9
24.1
23.7
21.8
55127
54851
54947
55042
55226
RNA Medical® Brand CVC 223 CO-Oximeter Calibration Verification Controls
are assayed materials used for confirming the calibration and linearity of total
hemoglobin and hemoglobin fractions on CO-Oximeter analyzers.
21.4 19.2 - 23.6
21.2 19.0 - 23.4
19.9 20.1 19.7 17.8 -
Level 1:
Level 2:
Level 3:
Level 4:
Level 5:
INTENDED USE
Radiometer
M2
M1
mean
MetHb
%
Nova
K
Y
range
COHb
%
ITC
ABL 80 Series
Y
O2Hb
%
IL
M
Y
M1
M2
75
Expected Values Chart
Analyzers
5 Levels
1010750 Bionostics INS01231 Rev. K 1 A Spot
Process
PANTONE
5 Black
1
2
3
4
Cyan
Magenta
Yellow
2748 U
Y
Key 19
M1
M2
25
CVC 223
CVC 223 CO-Oximeter Calibration Verification Controls
K
C
M
Y
M1
Key 6
M2
1010750 Bionostics INS01231 Rev. K
50
50
K
54947
2017-04
M2
2017-05
M1
55127
Y
Level 3
M
Level 1
C
CVC 223 CO-Oximeter Calibration Verification Controls
Key 7
CVC 223 CO-Oximeter Calibration Verification Controls
O2Hb
%
COHb
%
Expected Values Chart
MetHb
%
tHb
g/dL
O2Hb
%
COHb
%
MetHb
%
GRAY
tHb
g/dL
M1
Expected Values Chart
K
range
mean
range
mean
range
mean
range
mean
Analyzers
range
mean
range
mean
range
mean
range
C
mean
Analyzers
482
682
Synthesis Series
GEM OPL
GEM 4000
12.1
12.3
12.5
11.7
DNA2
81.7
83.9
82.9
83.8
77.7
79.9
78.6
79.8
13.6
13.7
12.5 - 14.7
12.6 - 14.8
81.2
82.5
14.1
13.1 - 15.1
14.1
14.6
14.2
13.6
DNA2
13.6
DNA2
13.1
13.6
13.2
12.6
-
14.1
14.3
14.7
13.7
DNA2
19.2
18.1
17.6
17.4
15.2
14.1
13.1
13.4
76.9 - 85.5
78.2 - 86.8
17.7
85.1
81.1 - 89.1
13.4
82.8
81.7
82.9
84.1
DNA2
84.1
DNA2
78.8
77.7
78.9
80.1
-
85.7
87.9
87.2
87.8
DNA2
0.6
0.4
0.7
0.3
–1.4 –1.6 –2.2 –1.7 -
13.2 - 22.2
0.8
–2.1 - 3.7
9.4 - 17.4
0.5
–1.5 - 2.5
18.2 14.2 - 22.2
17.5 13.5 - 21.5
17.0 13.0 - 21.0
13.6
9.6 - 17.6
DNA2
13.4
9.4 - 17.4
DNA2
1.0
1.0
0.8
1.5
DNA2
1.5
DNA2
–1.0 –1.0 –1.2 –0.5 -
-
23.2
22.1
22.1
21.4
2.6
2.4
3.6
2.3
75
DNA2
13.1
13.3
13.6
12.7
M2
30.2
28.5
DNA2
0.6 –1.4 - 2.6
0.3 –1.7 - 2.3
0.9 –2.0 - 3.8
ORL1
M2
5.0
4.9
DNA2
72.6 68.6 - 76.6
69.1 65.1 - 73.1
ORL1
ORL1
M1
DNA2
28.2 25.2 - 31.2
31.7 28.7 - 34.7
27.8 23.2 - 32.4
ORL1
Y
DNA2
4.9
4.3 - 5.5
4.7
4.1 - 5.3
5.0
4.4 - 5.6
ORL1
Key 8
482
682
Synthesis Series
GEM OPL
GEM 4000
M
IL
IL
ITC
ITC
25.6 - 34.8
23.9 - 33.1
71.3
64.3 - 78.3
1.3
AVOXimeter 1000E
AVOXimeter 4000
–1.6 - 4.2
C
4.4 - 5.6
4.3 - 5.5
K
AVOXimeter 1000E
AVOXimeter 4000
M
Nova
Nova
33.3
30.3 - 36.3
65.7
61.7 - 69.7
0.7
–1.3 - 2.7
CCX
64.6
61.7
61.7
62.6
24.7 - 30.7
26.4 - 32.4
68.0
69.5
5.6 - 6.8
4.3 - 5.5
5.3 - 6.5
33.6
28.2
34.0
30.6 - 36.6
25.2 - 31.2
31.0 - 37.0
65.6
70.6
65.6
29.2 - 35.2
-
72.6
69.7
69.7
70.6
1.0
1.1
1.1
2.5
DNA2
2.5
DNA2
–1.0
–0.9
–0.9
0.5
64.0 - 72.0
65.5 - 73.5
1.0
1.5
–1.0 - 3.0
–0.5 - 3.5
61.6 - 69.6
66.6 - 74.6
61.6 - 69.6
0.5
0.6
0.4
–1.5 - 2.5
–1.4 - 2.6
–1.6 - 2.4
62.6 - 70.6
-
OSM 3
ABL 500 Series
ABL 600 Series
ABL 700 Series
ABL 80 Series
ABL 800 Series
NPT 7
3.0
3.1
3.1
4.5
0.5 - 4.5
-
15.1
15.6
15.2
14.6
12.6 - 14.6
-
86.8
85.7
86.9
88.1
80.1 - 88.1
3.0
3.0
2.8
3.5
–0.5 - 3.5
Roche
Roche
12.8
13.0
11.8 - 13.8
12.0 - 14.0
83.3
83.6
79.3 - 87.3
79.6 - 87.6
15.4
14.5
11.4 - 19.4
10.5 - 18.5
0.8
1.3
–1.2 - 2.8
–0.7 - 3.3
14.5
13.3
14.4
13.5 - 15.5
12.3 - 14.3
13.4 - 15.4
83.8
81.3
83.8
79.8 - 87.8
77.3 - 85.3
79.8 - 87.8
15.5
17.6
15.5
11.5 - 19.5
13.6 - 21.6
11.5 - 19.5
0.4
0.5
0.4
–1.6 - 2.4
–1.5 - 2.5
–1.6 - 2.4
75
Cobas b 221
OMNI Series
M2
Cobas b 221
OMNI Series
M1
68.6
65.7
65.7
66.6
DNA2
66.6
DNA2
Y
27.7
29.4
35.6
37.2
38.2
35.2
M
4.0 - 5.2
4.0 - 5.2
4.0 - 5.2
-
C
29.6
31.2
32.2
29.2
K
32.6
34.2
35.2
32.2
DNA2
32.2
DNA2
75
6.2
4.9
5.9
5.8
5.9
5.9
5.2
75
4.6
4.6
-
M2
4.6
4.7
4.7
4.0
Key 10
5.2
5.3
5.3
4.6
DNA2
4.6
DNA2
M1
Radiometer
OSM 3
ABL 500 Series
ABL 600 Series
ABL 700 Series
ABL 80 Series
ABL 800 Series
NPT 7
Y
4.8 - 6.0
Key 9
5.4
CCX
Radiometer
C
400 Series
800 Series
1200 Series
K
400 Series
800 Series
1200 Series
GRAY
Siemens (Bayer)
Siemens (Bayer)
M
Y
Key 11
M1
Level 4
55042
2017-04
75
54851
M2
Level 2
2017-04
75
range
mean
COHb
%
range
mean
Expected Values Chart
MetHb
%
range
mean
range
mean
Analyzers
O2Hb
%
range
mean
COHb
%
range
mean
MetHb
%
range
mean
range
89.2 - 98.2
91.0 - 100.0
2.2
1.3
1.1
0.2
-
10.2
9.3
9.1
8.2
DNA2
0.8
0.7
0.8
0.6
–1.2
–1.3
–2.1
–1.4
-
ITC
DNA2
16.3
16.2
16.8
15.7
482
682
Synthesis Series
GEM OPL
GEM 4000
2.8
2.7
3.7
2.6
DNA2
53.7
59.0
54.9
56.2
49.7
55.0
50.6
52.2
16.8 15.5 - 18.1
16.8 15.5 - 18.1
54.5
54.5
18.2 17.0 - 19.4
17.4
18.0
17.6
16.4
DNA2
16.4
DNA2
15.1
15.0
15.5
14.5
-
17.5
17.4
18.1
16.9
DNA2
46.5
44.7
44.9
44.7
42.5 40.7 39.6 40.7 -
50.2 - 58.8
50.2 - 58.8
44.7
58.2
54.2 - 62.2
40.7
56.2
55.5
56.6
57.7
DNA2
57.9
DNA2
52.2
51.5
52.6
53.7
-
57.7
63.0
59.2
60.2
DNA2
0.3
0.2
0.4
0.0
–1.7 –1.8 –2.5 –2.0 -
39.4 - 50.0
0.4
–2.5 - 3.3
36.7 - 44.7
0.2
–1.8 - 2.2
43.7 39.7 - 47.7
43.7 39.7 - 47.7
43.0 39.0 - 47.0
41.1 37.1 - 45.1
DNA2
41.1 37.1 - 45.1
DNA2
0.7
0.5
0.5
2.6
DNA2
2.5
DNA2
–1.3 –1.5 –1.5 0.6 -
50.5
48.7
50.2
48.7
2.3
2.2
3.3
2.0
C
93.7
95.5
DNA2
6.2
5.3
5.1
4.2
K
7.1 - 8.5
7.1 - 8.5
99.3
102.2
100.3
101.4
ITC
1.0
AVOXimeter 1000E
AVOXimeter 4000
–1.9 - 3.9
Nova
7.1 - 8.5
97.6
92.6 - 102.6
1.8
–2.2 - 5.8
0.6
–1.4 - 2.6
CCX
M2
7.8
CCX
M1
Nova
Y
1.1 - 9.1
M
5.1
Key 13
AVOXimeter 1000E
AVOXimeter 4000
90.1
89.8
89.8
90.7
-
100.1
99.8
99.8
100.7
1.8
1.4
1.4
–1.9
-
9.8
9.4
9.4
6.1
-
2.9
3.1
3.1
3.5
OSM 3
ABL 500 Series
ABL 600 Series
ABL 700 Series
ABL 80 Series
ABL 800 Series
NPT 7
–0.5 - 3.5
-
18.6
19.2
18.8
17.6
15.2 -17.6
-
60.2
59.5
60.6
61.7
53.9 - 61.9
2.7
2.5
2.5
4.6
0.5 - 4.5
3.9
3.2
–0.1 - 7.9
–0.8 - 7.2
1.0
1.0
–1.0 - 3.0
–1.0 - 3.0
9.1
7.4
8.7
8.4 - 9.8
6.7 - 8.1
8.0 - 9.4
95.5
94.1
95.5
90.5 - 100.5
89.1 - 99.1
90.5 - 100.5
3.9
5.1
3.9
–0.1 - 7.9
1.1 - 9.1
–0.1 - 7.9
0.7
0.7
0.7
–1.3 - 2.7
–1.3 - 2.7
–1.3 - 2.7
Siemens (Bayer)
Cobas b 221
OMNI Series
16.0 14.8 - 17.2
16.1 14.9 - 17.3
55.0
56.5
51.0 - 59.0
52.5 - 60.5
42.5
40.3
38.5 - 46.5
36.3 - 44.3
0.6
1.2
–1.4 - 2.6
–0.8 - 3.2
17.3 16.1 - 18.5
17.1 15.9 - 18.3
17.4 16.2 - 18.6
58.0
55.2
58.0
54.0 - 62.0
51.2 - 59.2
54.0 - 62.0
41.3
44.1
41.3
37.3 - 45.3
40.1 - 48.1
37.3 - 45.3
0.1
0.1
0.1
–1.9 - 2.1
–1.9 - 2.1
–1.9 - 2.1
K
89.8 - 99.8
90.7 - 100.7
4
94.8
95.7
3
7.3 - 8.7
6.6 - 8.0
4
8.0
7.3
3
Roche
Cobas b 221
OMNI Series
Siemens (Bayer)
C
M
Y
400 Series
800 Series
1200 Series
Key 15
400 Series
800 Series
1200 Series
1/2/3/4 Y 1/2/3/4 M1
1
2
1
2
Roche
16.2
16.8
16.4
15.2
M2
–1.1
–0.9
–0.9
–0.5
M1
–1.9 - 6.1
0.9
1.1
1.1
1.5
DNA2
1.5
DNA2
Y
90.5 - 100.5
5.8
5.4
5.4
2.1
DNA2
2.1
DNA2
M
7.1 - 8.5
95.1
94.8
94.8
95.7
DNA2
95.5
DNA2
C
9.1
9.0
8.9
8.5
K
-
GRAY
7.7
7.6
7.5
7.1
Key 14
8.4
8.3
8.2
7.8
DNA2
7.8
DNA2
OSM 3
ABL 500 Series
ABL 600 Series
ABL 700 Series
ABL 80 Series
ABL 800 Series
NPT 7
4
Radiometer
1/2/3/4 M
1
2
3
Radiometer
1/2/3/4 C
1
2
7.8
7.8
-
1/2/3/4 K
1
2
89.3
92.2
91.3
91.4
M2
DNA2
94.3
97.2
95.8
96.4
4
8.3
8.0
8.5
8.0
-
3
6.9
6.6
7.1
6.6
4
DNA2
7.6
7.3
7.8
7.3
3
482
682
Synthesis Series
GEM OPL
GEM 4000
M1
IL
Y
Key 12
IL
tHb
g/dL
M
mean
Analyzers
O2Hb
%
C
tHb
g/dL
K
Expected Values Chart
M1
M2
3
3
4
1/2/3/4 M2
1
2
2
Y+M
K
2017-04
M2
54947
2017-05
M1
55127
Y
Level 3
M
Level 1
C
CVC 223 CO-Oximeter Calibration Verification Controls
Key 16
CVC 223 CO-Oximeter Calibration Verification Controls
Y+C
range
mean
COHb
%
range
mean
Expected Values Chart
MetHb
%
range
mean
range
tHb
g/dL
mean
Analyzers
O2Hb
%
range
mean
COHb
%
range
mean
MetHb
%
range
mean
C
mean
Analyzers
O2Hb
%
K
tHb
g/dL
GRAY
Expected Values Chart
range
M
IL
AVOXimeter 1000E
AVOXimeter 4000
4.4 - 5.6
4.3 - 5.5
25.6 - 34.8
23.9 - 33.1
71.3
64.3 - 78.3
1.3
AVOXimeter 1000E
AVOXimeter 4000
–1.6 - 4.2
14.1
14.6
14.2
13.6
DNA2
13.6
DNA2
13.1
13.6
13.2
12.6
–2.1 - 3.7
5.4
CCX
4.8 - 6.0
33.3
30.3 - 36.3
65.7
61.7 - 69.7
0.7
–1.3 - 2.7
CCX
85.1
81.1 - 89.1
13.4
9.4 - 17.4
0.5
–1.5 - 2.5
82.8
81.7
82.9
84.1
DNA2
84.1
DNA2
78.8
77.7
78.9
80.1
18.2 14.2 - 22.2
17.5 13.5 - 21.5
17.0 13.0 - 21.0
13.6
9.6 - 17.6
DNA2
13.4
9.4 - 17.4
DNA2
1.0
1.0
0.8
1.5
DNA2
1.5
DNA2
–1.0 –1.0 –1.2 –0.5 -
Radiometer
Radiometer
32.6
34.2
35.2
32.2
DNA2
32.2
DNA2
29.6
31.2
32.2
29.2
4.0 - 5.2
4.0 - 5.2
27.7
29.4
5.6 - 6.8
4.3 - 5.5
5.3 - 6.5
33.6
28.2
34.0
4.0 - 5.2
-
35.6
37.2
38.2
35.2
68.6
65.7
65.7
66.6
DNA2
66.6
DNA2
64.6
61.7
61.7
62.6
24.7 - 30.7
26.4 - 32.4
68.0
69.5
30.6 - 36.6
25.2 - 31.2
31.0 - 37.0
65.6
70.6
65.6
29.2 - 35.2
-
72.6
69.7
69.7
70.6
1.0
1.1
1.1
2.5
DNA2
2.5
DNA2
–1.0
–0.9
–0.9
0.5
64.0 - 72.0
65.5 - 73.5
1.0
1.5
–1.0 - 3.0
–0.5 - 3.5
61.6 - 69.6
66.6 - 74.6
61.6 - 69.6
0.5
0.6
0.4
–1.5 - 2.5
–1.4 - 2.6
–1.6 - 2.4
62.6 - 70.6
-
OSM 3
ABL 500 Series
ABL 600 Series
ABL 700 Series
ABL 80 Series
ABL 800 Series
NPT 7
3.0
3.1
3.1
4.5
0.5 - 4.5
-
15.1
15.6
15.2
14.6
12.6 - 14.6
-
86.8
85.7
86.9
88.1
80.1 - 88.1
3.0
3.0
2.8
3.5
–0.5 - 3.5
Roche
Cobas b 221
OMNI Series
11.8 - 13.8
12.0 - 14.0
83.3
83.6
79.3 - 87.3
79.6 - 87.6
15.4
14.5
11.4 - 19.4
10.5 - 18.5
0.8
1.3
–1.2 - 2.8
–0.7 - 3.3
14.5
13.3
14.4
13.5 - 15.5
12.3 - 14.3
13.4 - 15.4
83.8
81.3
83.8
79.8 - 87.8
77.3 - 85.3
79.8 - 87.8
15.5
17.6
15.5
11.5 - 19.5
13.6 - 21.6
11.5 - 19.5
0.4
0.5
0.4
–1.6 - 2.4
–1.5 - 2.5
–1.6 - 2.4
GRAY
12.8
13.0
25
Cobas b 221
OMNI Series
M2
Roche
Siemens (Bayer)
Siemens (Bayer)
C
M
400 Series
800 Series
1200 Series
K
400 Series
800 Series
1200 Series
M1
M2
25
Level 4
55042
2017-04
2017-04
25
54851
Y
Key 20
Level 2
M1
6.2
4.9
5.9
5.8
5.9
5.9
5.2
M
4.6
4.6
-
C
4.6
4.7
4.7
4.0
K
5.2
5.3
5.3
4.6
DNA2
4.6
DNA2
Key 19
OSM 3
ABL 500 Series
ABL 600 Series
ABL 700 Series
ABL 80 Series
ABL 800 Series
NPT 7
Y
13.1 - 15.1
0.8
25
14.1
13.2 - 22.2
25
17.7
Nova
Nova
M2
76.9 - 85.5
78.2 - 86.8
2.6
2.4
3.6
2.3
M1
81.2
82.5
–1.4 –1.6 –2.2 –1.7 -
23.2
22.1
22.1
21.4
Y
12.5 - 14.7
12.6 - 14.8
DNA2
0.6
0.4
0.7
0.3
-
M
15.2
14.1
13.1
13.4
85.7
87.9
87.2
87.8
C
13.6
13.7
DNA2
19.2
18.1
17.6
17.4
-
K
77.7
79.9
78.6
79.8
14.1
14.3
14.7
13.7
ITC
ITC
K
range
mean
COHb
%
range
mean
Expected Values Chart
MetHb
%
range
mean
range
mean
Analyzers
O2Hb
%
range
mean
COHb
%
range
mean
MetHb
%
range
mean
range
IL
7.1 - 8.5
7.1 - 8.5
93.7
95.5
89.2 - 98.2
91.0 - 100.0
99.3
102.2
100.3
101.4
DNA2
6.2
5.3
5.1
4.2
2.2
1.3
1.1
0.2
-
10.2
9.3
9.1
8.2
DNA2
0.8
0.7
0.8
0.6
–1.2
–1.3
–2.1
–1.4
-
ITC
DNA2
16.3
16.2
16.8
15.7
482
682
Synthesis Series
GEM OPL
GEM 4000
2.8
2.7
3.7
2.6
DNA2
53.7
59.0
54.9
56.2
49.7
55.0
50.6
52.2
16.8 15.5 - 18.1
16.8 15.5 - 18.1
54.5
54.5
18.2 17.0 - 19.4
17.4
18.0
17.6
16.4
DNA2
16.4
DNA2
15.1
15.0
15.5
14.5
-
17.5
17.4
18.1
16.9
DNA2
46.5
44.7
44.9
44.7
42.5 40.7 39.6 40.7 -
50.2 - 58.8
50.2 - 58.8
44.7
58.2
54.2 - 62.2
40.7
56.2
55.5
56.6
57.7
DNA2
57.9
DNA2
52.2
51.5
52.6
53.7
-
57.7
63.0
59.2
60.2
DNA2
0.3
0.2
0.4
0.0
–1.7 –1.8 –2.5 –2.0 -
39.4 - 50.0
0.4
–2.5 - 3.3
36.7 - 44.7
0.2
–1.8 - 2.2
43.7 39.7 - 47.7
43.7 39.7 - 47.7
43.0 39.0 - 47.0
41.1 37.1 - 45.1
DNA2
41.1 37.1 - 45.1
DNA2
0.7
0.5
0.5
2.6
DNA2
2.5
DNA2
–1.3 –1.5 –1.5 0.6 -
50.5
48.7
50.2
48.7
2.3
2.2
3.3
2.0
1.1 - 9.1
1.0
AVOXimeter 1000E
AVOXimeter 4000
–1.9 - 3.9
Nova
Key 22
5.1
M
ITC
AVOXimeter 1000E
AVOXimeter 4000
7.1 - 8.5
97.6
92.6 - 102.6
1.8
–2.2 - 5.8
0.6
–1.4 - 2.6
CCX
50
7.8
CCX
Radiometer
M2
Nova
90.1
89.8
89.8
90.7
-
100.1
99.8
99.8
100.7
1.8
1.4
1.4
–1.9
-
9.8
9.4
9.4
6.1
–1.9 - 6.1
–1.1
–0.9
–0.9
–0.5
-
2.9
3.1
3.1
3.5
OSM 3
ABL 500 Series
ABL 600 Series
ABL 700 Series
ABL 80 Series
ABL 800 Series
NPT 7
–0.5 - 3.5
-
18.6
19.2
18.8
17.6
15.2 -17.6
-
60.2
59.5
60.6
61.7
53.9 - 61.9
2.7
2.5
2.5
4.6
0.5 - 4.5
50
Roche
16.2
16.8
16.4
15.2
M2
0.9
1.1
1.1
1.5
DNA2
1.5
DNA2
Roche
89.8 - 99.8
90.7 - 100.7
3.9
3.2
–0.1 - 7.9
–0.8 - 7.2
1.0
1.0
–1.0 - 3.0
–1.0 - 3.0
9.1
7.4
8.7
8.4 - 9.8
6.7 - 8.1
8.0 - 9.4
95.5
94.1
95.5
90.5 - 100.5
89.1 - 99.1
90.5 - 100.5
3.9
5.1
3.9
–0.1 - 7.9
1.1 - 9.1
–0.1 - 7.9
0.7
0.7
0.7
–1.3 - 2.7
–1.3 - 2.7
–1.3 - 2.7
Siemens (Bayer)
Cobas b 221
OMNI Series
16.0 14.8 - 17.2
16.1 14.9 - 17.3
55.0
56.5
51.0 - 59.0
52.5 - 60.5
42.5
40.3
38.5 - 46.5
36.3 - 44.3
0.6
1.2
–1.4 - 2.6
–0.8 - 3.2
17.3 16.1 - 18.5
17.1 15.9 - 18.3
17.4 16.2 - 18.6
58.0
55.2
58.0
54.0 - 62.0
51.2 - 59.2
54.0 - 62.0
41.3
44.1
41.3
37.3 - 45.3
40.1 - 48.1
37.3 - 45.3
0.1
0.1
0.1
–1.9 - 2.1
–1.9 - 2.1
–1.9 - 2.1
C
Siemens (Bayer)
M
400 Series
800 Series
1200 Series
Key 24
400 Series
800 Series
1200 Series
M1
94.8
95.7
Y
7.3 - 8.7
6.6 - 8.0
K
8.0
7.3
50
Cobas b 221
OMNI Series
M1
90.5 - 100.5
5.8
5.4
5.4
2.1
DNA2
2.1
DNA2
Y
7.1 - 8.5
95.1
94.8
94.8
95.7
DNA2
95.5
DNA2
M
9.1
9.0
8.9
8.5
C
-
K
7.7
7.6
7.5
7.1
Key 23
8.4
8.3
8.2
7.8
DNA2
7.8
DNA2
GRAY
Radiometer
OSM 3
ABL 500 Series
ABL 600 Series
ABL 700 Series
ABL 80 Series
ABL 800 Series
NPT 7
M1
7.8
7.8
-
Y
89.3
92.2
91.3
91.4
C
DNA2
94.3
97.2
95.8
96.4
K
8.3
8.0
8.5
8.0
-
50
6.9
6.6
7.1
6.6
25
DNA2
7.6
7.3
7.8
7.3
M2
482
682
Synthesis Series
GEM OPL
GEM 4000
M1
IL
tHb
g/dL
Y
mean
Analyzers
O2Hb
%
M
tHb
g/dL
C
Expected Values Chart
Key 21
1010750 Bionostics INS01231 Rev. K 1 B Spot
Process
PANTONE
5 Black
1
2
3
4
Cyan
Magenta
Yellow
2748 U
DNA2
81.7
83.9
82.9
83.8
-
P
12.1
12.3
12.5
11.7
M+C
DNA2
13.1
13.3
13.6
12.7
M2
482
682
Synthesis Series
GEM OPL
GEM 4000
M1
30.2
28.5
DNA2
0.6 –1.4 - 2.6
0.3 –1.7 - 2.3
0.9 –2.0 - 3.8
ORL1
Part No. K-40-6(D)
5.0
4.9
DNA2
72.6 68.6 - 76.6
69.1 65.1 - 73.1
ORL1
ORL1
Key 18
DNA2
28.2 25.2 - 31.2
31.7 28.7 - 34.7
27.8 23.2 - 32.4
ORL1
Komori/GATF
DNA2
4.9
4.3 - 5.5
4.7
4.1 - 5.3
5.0
4.4 - 5.6
ORL1
Y
482
682
Synthesis Series
GEM OPL
GEM 4000
Key 17
IL
M2
50
2
3
50
K
C
mean
range
mean
Expected Values Chart
MetHb
%
range
mean
range
tHb
g/dL
mean
Analyzers
O2Hb
%
range
mean
COHb
%
range
mean
MetHb
%
range
mean
range
M
range
COHb
%
C
mean
O2Hb
%
K
tHb
g/dL
GRAY
Expected Values Chart
2017-04
75
54947
2017-05
Analyzers
M2
55127
482
682
Synthesis Series
GEM OPL
GEM 4000
DNA2
13.1
13.3
13.6
12.7
12.1
12.3
12.5
11.7
DNA2
81.7
83.9
82.9
83.8
77.7
79.9
78.6
79.8
13.6
13.7
12.5 - 14.7
12.6 - 14.8
81.2
82.5
14.1
13.1 - 15.1
14.1
14.6
14.2
13.6
DNA2
13.6
DNA2
13.1
13.6
13.2
12.6
-
14.1
14.3
14.7
13.7
DNA2
19.2
18.1
17.6
17.4
15.2
14.1
13.1
13.4
76.9 - 85.5
78.2 - 86.8
17.7
85.1
81.1 - 89.1
13.4
82.8
81.7
82.9
84.1
DNA2
84.1
DNA2
78.8
77.7
78.9
80.1
-
85.7
87.9
87.2
87.8
DNA2
0.6
0.4
0.7
0.3
–1.4 –1.6 –2.2 –1.7 -
13.2 - 22.2
0.8
–2.1 - 3.7
9.4 - 17.4
0.5
–1.5 - 2.5
18.2 14.2 - 22.2
17.5 13.5 - 21.5
17.0 13.0 - 21.0
13.6
9.6 - 17.6
DNA2
13.4
9.4 - 17.4
DNA2
1.0
1.0
0.8
1.5
DNA2
1.5
DNA2
–1.0 –1.0 –1.2 –0.5 -
-
23.2
22.1
22.1
21.4
2.6
2.4
3.6
2.3
K
25.6 - 34.8
23.9 - 33.1
71.3
64.3 - 78.3
1.3
AVOXimeter 1000E
AVOXimeter 4000
–1.6 - 4.2
M
4.4 - 5.6
4.3 - 5.5
Nova
Nova
4.8 - 6.0
33.3
30.3 - 36.3
65.7
61.7 - 69.7
0.7
–1.3 - 2.7
CCX
M2
5.4
CCX
27.7
29.4
5.6 - 6.8
4.3 - 5.5
5.3 - 6.5
33.6
28.2
34.0
35.6
37.2
38.2
35.2
68.6
65.7
65.7
66.6
DNA2
66.6
DNA2
64.6
61.7
61.7
62.6
24.7 - 30.7
26.4 - 32.4
68.0
69.5
30.6 - 36.6
25.2 - 31.2
31.0 - 37.0
65.6
70.6
65.6
29.2 - 35.2
-
72.6
69.7
69.7
70.6
1.0
1.1
1.1
2.5
DNA2
2.5
DNA2
–1.0
–0.9
–0.9
0.5
64.0 - 72.0
65.5 - 73.5
1.0
1.5
–1.0 - 3.0
–0.5 - 3.5
61.6 - 69.6
66.6 - 74.6
61.6 - 69.6
0.5
0.6
0.4
–1.5 - 2.5
–1.4 - 2.6
–1.6 - 2.4
62.6 - 70.6
-
OSM 3
ABL 500 Series
ABL 600 Series
ABL 700 Series
ABL 80 Series
ABL 800 Series
NPT 7
3.0
3.1
3.1
4.5
0.5 - 4.5
-
15.1
15.6
15.2
14.6
12.6 - 14.6
-
86.8
85.7
86.9
88.1
80.1 - 88.1
3.0
3.0
2.8
3.5
–0.5 - 3.5
12.8
13.0
11.8 - 13.8
12.0 - 14.0
83.3
83.6
79.3 - 87.3
79.6 - 87.6
15.4
14.5
11.4 - 19.4
10.5 - 18.5
0.8
1.3
–1.2 - 2.8
–0.7 - 3.3
14.5
13.3
14.4
13.5 - 15.5
12.3 - 14.3
13.4 - 15.4
83.8
81.3
83.8
79.8 - 87.8
77.3 - 85.3
79.8 - 87.8
15.5
17.6
15.5
11.5 - 19.5
13.6 - 21.6
11.5 - 19.5
0.4
0.5
0.4
–1.6 - 2.4
–1.5 - 2.5
–1.6 - 2.4
GRAY
Cobas b 221
OMNI Series
75
Cobas b 221
OMNI Series
M2
Roche
Roche
C
M
400 Series
800 Series
1200 Series
M1
Key 29
400 Series
800 Series
1200 Series
K
Siemens (Bayer)
Siemens (Bayer)
Y
4.0 - 5.2
4.0 - 5.2
4.0 - 5.2
-
M1
29.6
31.2
32.2
29.2
Y
32.6
34.2
35.2
32.2
DNA2
32.2
DNA2
M
6.2
4.9
5.9
5.8
5.9
5.9
5.2
C
4.6
4.6
-
K
4.6
4.7
4.7
4.0
75
5.2
5.3
5.3
4.6
DNA2
4.6
DNA2
Key 28
OSM 3
ABL 500 Series
ABL 600 Series
ABL 700 Series
ABL 80 Series
ABL 800 Series
NPT 7
75
Radiometer
Radiometer
M1
Key 27
AVOXimeter 1000E
AVOXimeter 4000
C
ITC
ITC
Y
30.2
28.5
DNA2
0.6 –1.4 - 2.6
0.3 –1.7 - 2.3
0.9 –2.0 - 3.8
ORL1
75
5.0
4.9
DNA2
72.6 68.6 - 76.6
69.1 65.1 - 73.1
ORL1
ORL1
75
DNA2
28.2 25.2 - 31.2
31.7 28.7 - 34.7
27.8 23.2 - 32.4
ORL1
M2
DNA2
4.9
4.3 - 5.5
4.7
4.1 - 5.3
5.0
4.4 - 5.6
ORL1
M1
482
682
Synthesis Series
GEM OPL
GEM 4000
Y
Key 26
IL
IL
M1
Level 3
Y
Level 1
M
CVC 223 CO-Oximeter Calibration Verification Controls
Key 25
CVC 223 CO-Oximeter Calibration Verification Controls
M2
star
Level 4
55042
2017-04
range
mean
range
mean
range
Analyzers
mean
O2Hb
%
range
mean
COHb
%
range
mean
MetHb
%
range
mean
range
M2
IL
tHb
g/dL
IL
7.1 - 8.5
7.1 - 8.5
93.7
95.5
89.2 - 98.2
91.0 - 100.0
99.3
102.2
100.3
101.4
DNA2
6.2
5.3
5.1
4.2
2.2
1.3
1.1
0.2
-
10.2
9.3
9.1
8.2
DNA2
0.8
0.7
0.8
0.6
–1.2
–1.3
–2.1
–1.4
-
2.8
2.7
3.7
2.6
ITC
1.1 - 9.1
1.0
–1.9 - 3.9
54.5
54.5
18.2 17.0 - 19.4
17.4
18.0
17.6
16.4
DNA2
16.4
DNA2
DNA2
0.3
0.2
0.4
0.0
–1.7 –1.8 –2.5 –2.0 -
50.2 - 58.8
50.2 - 58.8
44.7
39.4 - 50.0
0.4
–2.5 - 3.3
58.2
54.2 - 62.2
40.7
36.7 - 44.7
0.2
–1.8 - 2.2
56.2
55.5
56.6
57.7
DNA2
57.9
DNA2
52.2
51.5
52.6
53.7
43.7 39.7 - 47.7
43.7 39.7 - 47.7
43.0 39.0 - 47.0
41.1 37.1 - 45.1
DNA2
41.1 37.1 - 45.1
DNA2
0.7
0.5
0.5
2.6
DNA2
2.5
DNA2
–1.3 –1.5 –1.5 0.6 -
50.5
48.7
50.2
48.7
2.3
2.2
3.3
2.0
AVOXimeter 1000E
AVOXimeter 4000
97.6
92.6 - 102.6
1.8
–2.2 - 5.8
0.6
–1.4 - 2.6
CCX
GRAY
7.1 - 8.5
Radiometer
90.1
89.8
89.8
90.7
-
100.1
99.8
99.8
100.7
90.5 - 100.5
1.8
1.4
1.4
–1.9
-
9.8
9.4
9.4
6.1
–1.9 - 6.1
0.9
1.1
1.1
1.5
DNA2
1.5
DNA2
–1.1
–0.9
–0.9
–0.5
-
2.9
3.1
3.1
3.5
–0.5 - 3.5
OSM 3
ABL 500 Series
ABL 600 Series
ABL 700 Series
ABL 80 Series
ABL 800 Series
NPT 7
16.2
16.8
16.4
15.2
-
18.6
19.2
18.8
17.6
15.2 -17.6
-
60.2
59.5
60.6
61.7
53.9 - 61.9
2.7
2.5
2.5
4.6
0.5 - 4.5
star
5.8
5.4
5.4
2.1
DNA2
2.1
DNA2
M2
7.1 - 8.5
95.1
94.8
94.8
95.7
DNA2
95.5
DNA2
M
9.1
9.0
8.9
8.5
C
-
K
7.7
7.6
7.5
7.1
Key 32
8.4
8.3
8.2
7.8
DNA2
7.8
DNA2
Y+M
Roche
3.9
3.2
–0.1 - 7.9
–0.8 - 7.2
1.0
1.0
–1.0 - 3.0
–1.0 - 3.0
9.1
7.4
8.7
8.4 - 9.8
6.7 - 8.1
8.0 - 9.4
95.5
94.1
95.5
90.5 - 100.5
89.1 - 99.1
90.5 - 100.5
3.9
5.1
3.9
–0.1 - 7.9
1.1 - 9.1
–0.1 - 7.9
0.7
0.7
0.7
–1.3 - 2.7
–1.3 - 2.7
–1.3 - 2.7
Cobas b 221
OMNI Series
16.0 14.8 - 17.2
16.1 14.9 - 17.3
55.0
56.5
51.0 - 59.0
52.5 - 60.5
42.5
40.3
38.5 - 46.5
36.3 - 44.3
0.6
1.2
–1.4 - 2.6
–0.8 - 3.2
17.3 16.1 - 18.5
17.1 15.9 - 18.3
17.4 16.2 - 18.6
58.0
55.2
58.0
54.0 - 62.0
51.2 - 59.2
54.0 - 62.0
41.3
44.1
41.3
37.3 - 45.3
40.1 - 48.1
37.3 - 45.3
0.1
0.1
0.1
–1.9 - 2.1
–1.9 - 2.1
–1.9 - 2.1
Key 33
M2
400 Series
800 Series
1200 Series
M
Siemens (Bayer)
M1
89.8 - 99.8
90.7 - 100.7
Y
94.8
95.7
C
7.3 - 8.7
6.6 - 8.0
K
8.0
7.3
M1
42.5 40.7 39.6 40.7 -
57.7
63.0
59.2
60.2
Y
DNA2
46.5
44.7
44.9
44.7
-
star
7.8
Siemens (Bayer)
400 Series
800 Series
1200 Series
16.8 15.5 - 18.1
16.8 15.5 - 18.1
17.5
17.4
18.1
16.9
Nova
Roche
Cobas b 221
OMNI Series
49.7
55.0
50.6
52.2
-
M2
5.1
Radiometer
OSM 3
ABL 500 Series
ABL 600 Series
ABL 700 Series
ABL 80 Series
ABL 800 Series
NPT 7
DNA2
53.7
59.0
54.9
56.2
15.1
15.0
15.5
14.5
ITC
Nova
CCX
DNA2
16.3
16.2
16.8
15.7
Key 31
AVOXimeter 1000E
AVOXimeter 4000
482
682
Synthesis Series
GEM OPL
GEM 4000
M1
7.8
7.8
-
Y
89.3
92.2
91.3
91.4
M
DNA2
94.3
97.2
95.8
96.4
C
8.3
8.0
8.5
8.0
-
K
6.9
6.6
7.1
6.6
star
DNA2
7.6
7.3
7.8
7.3
star
482
682
Synthesis Series
GEM OPL
GEM 4000
M1
mean
Expected Values Chart
MetHb
%
Y
range
COHb
%
M
mean
O2Hb
%
Key 30
Analyzers
tHb
g/dL
C
Expected Values Chart
2017-04
K
54851
star
Level 2
Y+C
3
C+M
2
K
C
M
Y
M1
Key 34
M2
P
GRAY

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