cvc 223, rev.e1231 - rna medicalrnamedical.com/files/inserts/13/922335.pdf · cvc 223 co-oximeter...

CVC 223 CO-Oximeter Calibration Verification Controls

CVC 223 5 LevelsCVC 223 CO-Oximeter Calibration Verification Controls

I1231 Rev. 7/2017® ®

922335Set: 2020-09Set: CVC 2239513294860949569505295232

Level 1:Level 2:Level 3:Level 4:Level 5:

2020-092020-092020-102020-102020-10

Level 1:Level 2:Level 3:Level 4:Level 5:

INTENDED USERNA Medical® Brand CVC 223 CO-Oximeter Calibration Verification Controlsare assayed materials used for confirming the calibration and linearity of totalhemoglobin and hemoglobin fractions on CO-Oximeter analyzers.

PRODUCT DESCRIPTIONCVC 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 ofsolution. Ampuls are packaged in kits containing four (4) ampuls of each level.

Active Ingredients:CVC 223 is a purified bovine hemoglobin solution that has been saturated withcarbon monoxide or treated with precise concentrations of carbon monoxide.This control contains no preservatives and no human-based materials. It isconsidered good laboratory practice to follow the recommended "UniversalPrecautions" when handling any blood product.

STORAGEThe expiration date stated on the CVC 223 packaging is for product stored at2-8 °C. Avoid exposure to freezing and temperatures greater than 8 °C.

DIRECTIONS FOR USECVC 223 should be analyzed immediately after removal from refrigeration. 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 ofthese or any other control materials.

General Instructions1. Calibrate your CO-Oximeter according to the manufacturer’s recommendations.If the analyzer is a combination blood gas/CO-Oximetry system, a two-pointcalibration is suggested.

2. Beginning with level 1, gently invert the ampul to mix the solution. Tap theampul to restore the liquid to the bottom of the ampul.

3. Open the ampul by snapping off the tip at the score. Use the Snapperprovided to protect fingers from cuts.

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 providedfor 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 inthe 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 tothe 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 theExpected Value.

b) Connect the plotted points to visualize linearity.Note: Steps 7 and 8 may be performed on-line as a feature of PeerQC®

described below.

EXPECTED VALUESThe values for each control analyte on the enclosed Expected Values Chart arebased on multiple determinations performed on randomly selected samplesfrom each lot. The listing for each instrument represents the expected rangeand mean value of this range.The Expected Values are provided as a guide in evaluating analyzerperformance. Since instrument design and operating conditions may vary,each laboratory should establish its own acceptance criteria.

STATISTICAL SUPPORTRNA Medical PeerQC, available at www.RNAMedical.com, features web-based graphing and reporting for its Calibration Verification Controls and isavailable at no charge to RNA Medical customers. The graphing steps outlinedabove may be performed on-line as a feature of this service. Please contactRNA Medical or visit our website for information about utilizing PeerQC for thisproduct.

LIMITATIONS1. Extended exposure to temperatures greater than 8 °C will affect productperformance. If CVC 223 has turned brown in color, this change indicatesdeterioration and the formation of methemoglobin. In such a case, thecontrol is not suitable for use and should be discarded.

2. The methemoglobin in this control can confirm product storage temperatureintegrity as well as the performance of the MetHb channel on CO-Oximeters. Because of its limited range of values, it will not be of significantvalue in determining linearity, calibration verification, and reportable rangefor MetHb.

3. CVC 223 is sensitive to many instrument related factors that would affectanalytical results. It is a bovine blood-based material but does not containred cells. Therefore, it may not detect certain malfunctions that would affectthe testing of human blood.

4. This product is intended for use as a quality control material and can assistin evaluating the performance of laboratory instruments. It is not for use asa calibration standard and its use should not replace other aspects of acomplete quality control program.

RNA Medical is a registered trademark and PeerQC is a registered service mark of Bionostics, Inc.

AccrivaAVOXimeter 1000E

AVOXimeter 4000

IL482

682

Synthesis Series

GEM OPL

GEM Premier 4000

GEM Premier 5000

NovaCCX

pHOx Ultra

RadiometerABL 700 Series

ABL 800 Series

ABL 80 Series

ABL 90 Series

RocheCobas b 221

OMNI Series

Siemens400 Series

500 Series

1200 Series

tHb O2Hb COHb MetHb3

g/dL % % %

Expected Values Chart

mean rangeAnalyzers mean range mean range mean range

95232 2020-10Level 5

FOOTNOTES:1. ORL - Outside Reportable Limits of Analyzer2. DNA - Data Not Available at time of printing3. MetHb range cannot determine linearity, calibration verification or reportable range.

INSTRUMENT MANUFACTURERS

Accriva Diagnostics, San Diego, CAInstrumentation Laboratory, Lexington, MA

Nova Biomedical, Waltham, MARadiometer America, Westlake, OHRoche Diagnostics, Indianapolis, IN

Siemens Healthcare Diagnostics, Deerfield, IL

RNA Medical, Division of Bionostics, Inc.7 Jackson Road

Devens, MA 01434 USA978-772-9070 l 800-533-6162

www.RNAMedical.com

4

Consult Instructions for Use

Use ByStore At

For In Vitro Diagnostic Use

Lot Number

Catalog Number

Manufactured For

21.7 19.5 - 23.9 3.1 –4.9 - 11.1 21.7 19.5 - 23.9 1.2 –6.8 - 9.2 ORL 1 0.4 –2.5 - 3.3

DNA 2 DNA 2 DNA 2 DNA 2

20.5 18.5 - 22.5 1.4 –1.1 - 3.9 98.4 93.4 - 103.4 0.6 –1.4 - 2.6

19.0 17.0 - 21.0 2.6 0.1 - 5.1 96.8 91.8 - 101.8 0.1 –1.9 - 2.1 21.7 19.5 - 23.9 1.2 –6.8 - 9.2 ORL1 0.4 –2.5 - 3.3 20.1 18.1 - 22.1 1.2 –1.3 - 3.7 96.8 91.8 - 101.8 0.2 –1.8 - 2.2 DNA 2 DNA 2 DNA 2 DNA 2

23.6 21.6 - 25.6 3.3 0.8 - 5.8 95.2 90.2 - 100.2 0.3 –1.7 - 2.3 DNA 2 DNA 2 DNA 2 DNA 2

19.6 17.6 - 21.6 0.9 –1.6 - 3.4 94.7 89.7 - 99.7 3.4 1.4 - 5.4 19.6 17.6 - 21.6 0.9 –1.6 - 3.4 94.7 89.7 - 99.7 3.4 1.4 - 5.4



20.2 18.2 - 22.2 1.0 –1.5 - 3.5 95.8 90.8 - 100.8 0.8 –1.2 - 2.8 20.2 18.2 - 22.2 1.9 –0.6 - 4.4 93.8 88.8 - 98.8 1.3 –0.7 - 3.3

–21.6 19.6 - 23.6 5.5 3.0 - 8.0 92.6 87.6 - 97.6 0.2 –1.8 - 2.2 DNA 2 DNA 2 DNA 2 DNA 2

22.1 20.1 - 24.1 5.5 3.0 - 8.0 92.6 87.6 - 97.6 0.2 –1.8 - 2.2



AVOXimeter 4000

IL482

682

Synthesis Series

GEM OPL

GEM Premier 4000

GEM Premier 5000

NovaCCX

pHOx Ultra


ABL 800 Series

ABL 80 Series

ABL 90 Series

RocheCobas b 221

OMNI Series

Siemens400 Series

500 Series

1200 Series


g/dL % % %



95132 2020-09Level 1



AVOXimeter 4000

IL482

682

Synthesis Series

GEM OPL

GEM Premier 4000

GEM Premier 5000

NovaCCX

pHOx Ultra


ABL 800 Series

ABL 80 Series

ABL 90 Series

RocheCobas b 221

OMNI Series

Siemens400 Series

500 Series

1200 Series


g/dL % % %



94956 2020-10Level 3


AVOXimeter 4000

IL482

682

Synthesis Series

GEM OPL

GEM Premier 4000

GEM Premier 5000

NovaCCX

pHOx Ultra


ABL 800 Series

ABL 80 Series

ABL 90 Series

RocheCobas b 221

OMNI Series

Siemens400 Series

500 Series

1200 Series


g/dL % % %



94860 2020-09Level 2

2 3


AVOXimeter 4000

IL482

682

Synthesis Series

GEM OPL

GEM Premier 4000

GEM Premier 5000

NovaCCX

pHOx Ultra


ABL 800 Series

ABL 80 Series

ABL 90 Series

RocheCobas b 221

OMNI Series

Siemens400 Series

500 Series

1200 Series


g/dL % % %



95052 2020-10Level 4

4.7 4.1 - 5.3 33.5 28.9 - 38.1 4.7 4.1 - 5.3 32.2 27.6 - 36.8 68.9 61.9 - 75.9 0.5 –2.4 - 3.4


5.0 4.4 - 5.6 31.7 28.7 - 34.7 71.4 67.4 - 75.4 –0.7 –2.7 - 1.3 4.8 4.2 - 5.4 35.2 32.2 - 38.2 67.9 63.9 - 71.9 –1.0 –3.0 - 1.0 4.7 4.1 - 5.3 32.2 27.6 - 36.8 68.9 61.9 - 75.9 0.5 –2.4 - 3.4

ORL 1 ORL 1 ORL 1 ORL 1


5.5 4.9 - 6.1 36.8 33.8 - 39.8 64.5 60.5 - 68.5 –0.6 –2.6 - 1.4 DNA 2 DNA 2 DNA 2 DNA 2

4.7 4.1 - 5.3 35.7 32.7 - 38.7 65.4 61.4 - 69.4 1.2 –0.8 - 3.2 4.7 4.1 - 5.3 35.7 32.7 - 38.7 65.4 61.4 - 69.4 1.2 –0.8 - 3.2 DNA 2 DNA 2 DNA 2 DNA 2


4.7 4.1 - 5.3 31.2 28.2 - 34.2 66.8 62.8 - 70.8 –0.3 –2.3 - 1.7 4.7 4.1 - 5.3 32.9 29.9 - 35.9 68.3 64.3 - 72.3 0.2 –1.8 - 2.2

6.3 5.7 - 6.9 37.1 34.1 - 40.1 64.4 60.4 - 68.4 –0.8 –2.8 - 1.2 DNA 2 DNA 2 DNA 2 DNA 2

6.0 5.4 - 6.6 37.5 34.5 - 40.5 64.4 60.4 - 68.4 –0.9 –2.9 - 1.1

13.2 12.1 - 14.3 79.9 75.6 - 84.2 13.4 12.3 - 14.5 80.4 76.1 - 84.7 20.3 15.8 - 24.8 0.3 –2.7 - 3.2


12.6 11.6 - 13.6 81.2 77.2 - 85.2 20.3 16.3 - 24.3 0.0 –2.0 - 2.0

12.8 11.8 - 13.8 83.4 79.4 - 87.4 19.2 15.2 - 23.2 –0.2 –2.2 - 1.8 13.4 12.3 - 14.5 80.4 76.1 - 84.7 20.3 15.8 - 24.8 0.3 –2.7 - 3.2

12.2 11.2 - 13.2 83.3 79.3 - 87.3 18.5 14.5 - 22.5 –0.3 –2.3 - 1.7 DNA 2 DNA 2 DNA 2 DNA 2

13.6 12.6 - 14.6 84.6 80.6 - 88.6 14.5 10.5 - 18.5 –0.1 –2.1 - 1.9 DNA 2 DNA 2 DNA 2 DNA 2

13.1 12.1 - 14.1 83.6 79.6 - 87.6 14.7 10.7 - 18.7 0.9 –1.1 - 2.9

13.1 12.1 - 14.1 83.6 79.6 - 87.6 14.5 10.5 - 18.5 0.9 –1.1 - 2.9



12.3 11.3 - 13.3 82.8 78.8 - 86.8 16.5 12.5 - 20.5 0.2 –1.8 - 2.2 12.5 11.5 - 13.5 83.1 79.1 - 87.1 15.6 11.6 - 19.6 0.7 –1.3 - 2.7

14.0 13.0 - 15.0 83.3 79.3 - 87.3 16.6 12.6 - 20.6 –0.2 –2.2 - 1.8 DNA 2 DNA 2 DNA 2 DNA 2

13.9 12.9 - 14.9 83.3 79.3 - 87.3 16.6 12.6 - 20.6 –0.2 –2.2 - 1.8

8.2 7.5 - 8.9 92.4 87.9 - 96.9 8.1 7.4 - 8.8 94.1 89.6 - 98.6 7.6 3.6 - 11.6 0.6 –2.3 - 3.5


7.5 6.8 - 8.2 94.9 89.9 - 99.9 6.8 2.8 - 10.8 –0.1 –2.1 - 1.9 7.2 6.5 - 7.9 97.8 92.8 - 102.8 5.9 1.9 - 9.9 –0.2 –2.2 - 1.8 8.1 7.4 - 8.8 94.1 89.6 - 98.6 7.6 3.6 - 11.6 0.6 –2.3 - 3.5 7.2 6.5 - 7.9 97.0 92.0 - 102.0 4.8 0.8 - 8.8 –0.3 –2.3 - 1.7 DNA 2 DNA 2 DNA 2 DNA 2

7.7 7.0 - 8.4 98.2 93.2 - 103.2 2.4 –1.6 - 6.4 –0.3 –2.3 - 1.7 DNA 2 DNA 2 DNA 2 DNA 2

7.7 7.0 - 8.4 96.3 91.3 - 101.3 2.7 –1.3 - 6.7 0.6 –1.4 - 2.6 7.7 7.0 - 8.4 96.1 91.1 - 101.1 2.7 –1.3 - 6.7 0.6 –1.4 - 2.6



7.9 7.2 - 8.6 95.4 90.4 - 100.4 4.5 0.5 - 8.5 0.1 –1.9 - 2.1 7.2 6.5 - 7.9 96.3 91.3 - 101.3 3.8 –0.2 - 7.8 0.1 –1.9 - 2.1

9.0 8.3 - 9.7 96.1 91.1 - 101.1 4.5 0.5 - 8.5 –0.2 –2.2 - 1.8 DNA 2 DNA 2 DNA 2 DNA 2

8.6 7.9 - 9.3 96.1 91.1 - 101.1 4.5 0.5 - 8.5 –0.2 –2.2 - 1.8

17.0 15.7 - 18.3 53.6 49.3 - 57.9 16.7 15.4 - 18.0 53.5 49.2 - 57.8 47.4 42.1 - 52.7 0.0 –2.9 - 2.9


15.7 14.5 - 16.9 53.8 49.8 - 57.8 48.4 44.4 - 52.4 –0.7 –2.7 - 1.3 15.6 14.4 - 16.8 59.1 55.1 - 63.1 46.6 42.6 - 50.6 –0.8 –2.8 - 1.2 16.7 15.4 - 18.0 53.5 49.2 - 57.8 47.4 42.1 - 52.7 0.0 –2.9 - 2.9 15.1 13.9 - 16.3 56.3 52.3 - 60.3 46.6 42.6 - 50.6 –1.0 –3.0 - 1.0 DNA 2 DNA 2 DNA 2 DNA 2

17.6 16.4 - 18.8 58.3 54.3 - 62.3 42.6 38.6 - 46.6 –0.8 –2.8 - 1.2 DNA 2 DNA 2 DNA 2 DNA 2

15.8 14.6 - 17.0 57.8 53.8 - 61.8 43.0 39.0 - 47.0 1.6 –0.4 - 3.6 15.8 14.6 - 17.0 58.0 54.0 - 62.0 43.0 39.0 - 47.0 1.5 –0.5 - 3.5 DNA 2 DNA 2 DNA 2 DNA 2


15.4 14.2 - 16.6 55.1 51.1 - 59.1 44.4 40.4 - 48.4 –0.4 –2.4 - 1.6 15.5 14.3 - 16.7 56.6 52.6 - 60.6 42.2 38.2 - 46.2 0.2 –1.8 - 2.2

16.7 15.5 - 17.9 58.1 54.1 - 62.1 43.2 39.2 - 47.2 –0.9 –2.9 - 1.1DNA 2 DNA 2 DNA 2 DNA 2

16.8 15.6 - 18.0 58.1 54.1 - 62.1 43.2 39.2 - 47.2 –0.9 –2.9 - 1.1

cvc 223, rev.e1231 - rna medicalrnamedical.com/files/inserts/13/922335.pdf · cvc 223 co-oximeter...

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