VITROS Chemistry Products Calibrator Kit 32
Intended Use
For in vitro diagnostic use only.VITROS Chemistry Products Calibrator Kit 32 is used to calibrate VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of sodium, chloride, potassium and ECO2..
Reagents
This product is prepared from processed water to which inorganic salts, a polymer and preservatives have been added.
Nominal Values and TraceabilityNominal values are representative target concentrations used during the calibrator manufacturing process. The particular Supplementary Assigned Value (SAV) for an analyte in each vial is the generation-specific assigned concentration for VITROS Chemistry Products Slides, and is provided on the calibration media. To view this value, refer to the operating instructions for your system. Refer to the analyte-specific Instructions for Use for additional calibration information.
Nominal Values
|
Analyte |
Calibrator Vial 1 | Calibrator Vial 2 | Calibrator Vial 3 | Calibrator Vial 4 |
Units |
| Carbonate | 22 | 37 | 6 | – | mmol/L |
| Chloride | 65 | 120 | 280 | 15 | mmol/L |
| Potassium | 1.0 | 120.0 | 11.0 | 25.0 | mmol/L |
| Sodium | 95 | 54 | 320 | 14 | mmol/L |
Note: A dash indicates those analytes that are not targeted in a calibrator bottle.
Traceability of Values
| Analyte/Chemistry | Reference Material | Comparative Method | |
| Carbonate | ECO2 | NIST SRM 351 | Thermal Conductivity 1 2 |
| Chloride | Cl- | NIST SRM 919 | Coulometry 3 4 |
| Potassium | K+ | NIST SRM 918 | Flame atomic emission spectroscopy 5 |
| Sodium | Na+ | NIST SRM 919 | Flame atomic emission spectroscopy 5 |
Warnings and Precautions
For in vitro diagnostic use only.
Warning: The packaging (vial stopper) of this product contains dry natural rubber, which may cause allergic reactions in some individuals.
Contains ProClin 950 (CAS 2682-20-4) 6The VITROS Chemistry Products Calibrator Kit 32 contains 0.052% ProClin 950 (2-methyl-4-isothiazolin-3-one). H317: May cause an allergic skin reaction. P280: Wear protective gloves/protective clothing/eye protection/face protection. P302 + P352: IF ON SKIN: Wash with plenty of soap and water. P333 + P313: If skin irritation or rash occurs: Get medical advice/attention. P363: Wash contaminated clothing before reuse.Refer to www.Orthoclinicaldiagnostics.com for the Safety Data Sheets and for Ortho contact information.Not all products and systems are available in all countries.
Storage
| Reagent | Storage Condition | Stability |
| Unopened | Refrigerated 2–8 °C (36–46 °F) | Until expiration date |
| Opened | Refrigerated 2–8 °C (36–46 °F) | ≤ 24 hours if tightly
stoppered |
Refer to the analytic specific Instructions for Use for special calibration precautions.
Materials Provided
VITROS Chemistry Products Calibrator Kit 32
- 3 vials each of calibrator 1, 2, 3, and 4
- 12 calibrator bar code labels (For use on VITROS 4600 Chemistry System and the VITROS 5600 Integrated System only)
Testing Procedure
Do not use visibly damaged product or product with incompletely sealed packaging.Be sure to use components from the same kit lot number.
- Calibrate Na+, K+, Cl- and ECO2 together the first time using VITROS Chemistry Products Calibrator Kit 32.
- Enter the ‘Calibration Programs’ or ‘Calibration Programming’ screen. Delete any calibration programs which include Na+, K+, Cl- or ECO2 (permanent and incomplete programs).
- Load the most recent assay data disk (ADD) or calibration disk that supports VITROS Chemistry Products Calibrator Kit 32.
- When prompted, select ‘Change Kit’ or ‘Change to New Cal Kit’ and then touch ‘Next’ or ‘Continue’ and wait for the data to load. This may take a few minutes.
- When prompted, select ‘32’ to configure the VITROS System for VITROS Chemistry Products Calibrator Kit 32, then touch ‘Next’ or ‘Continue’ and wait for the data to load.
- Program and run a calibration tray for Na+, K+, Cl- and ECO2.
Operating Instructions
- Mix the vial thoroughly by gently inverting several times. DO NOT SHAKE.
- Place fluid in a cup and cover with a pierceable cap.
- Restopper the vial and immediately return it to the refrigerator.
- Bring the cup to room temperature, 18–28 °C (64–82 °F), before analysis (approximately 10 minutes for refrigerated material).
- Analyze according to the operating instructions for your system.
- Discard any unused portion in the cup following testing.
- Use refrigerated fluid within 24 hours.
Limitations
The commutability of the VITROS Chemistry Products Calibrator Kit 32 for Na+, K+, Cl- and ECO2 has been demonstrated among VITROS MicroSlide methods. Commutability of this calibrator has not been established with other methods.
References
- Van Slyke D.C., Neill J.M. J. Biol. Chem., 1924; 61: 523-6.
- Corning 956 Carbon Dioxide Analyzer Instruction Manual, Corning Medical, Medfield, MA, 1977.
- Velapoldi RA, Paule RC, Schaffer R, Mandel TJ, Gramlich JW. Standard reference materials: a reference method for the determination of chloride in serum. National Institute of Standards and Technology Special Publication 260-67, Washington, DC, 1979.
- Dietz A.A., Bond E.E., Chloride, coulomeric-amperometric methods. In: Faulkner W.R., Meites S., eds. Selected Methods of Clinical Chemistry, 1982, 9: 149-52.
- Velapoldi RA, et al. A reference method for the determination of potassium in serum. NIST Special Publication 260-63, US Department of Commerce, National Institute of Standards and Technology, Gaithersburg, MD, 1978.
- Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.
Glossary of Symbols
Revision History
| Date of Revision | Version | Description of Technical Changes* |
| 2019-01-08 | 1.0 | Initial version of Instructions for Use |
When this Instructions For Use is replaced, sign and date below and retain as specified by local regulations or laboratory policies, as appropriate.
Ortho-Clinical Diagnostics Felindre MeadowsPencoed Bridgend CF35 5PZ United KingdomOrtho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626USA
References
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