Cal-o-trolCD
(Bloof for Calibration)
DIMDI Reg.-Nr.: DE/CA22/1116-39-IVD
INTENDED USE
Cal-o-trol CD is designed for use in the calibration of Cell-Dyn hematology instruments. Refer to the assay sheet for specific instrument models. Values are provided for WBC, RBC, HGB, MCV/HCT, and PLT.
SUMMARY AND PRINCIPLE
The WBC, RBC, HGB, MCV/HCT, and PLT parameters on hematology instruments require calibration on a periodic basis.1 Cal-o-trol CD is a stable preparation which can be used to perform the calibration. The assigned values for Cal-o-trol CD are based on replicate analyses on instruments which have been whole blood calibrated to values obtained from reference methods. The instruments use the manufacturer's recommended reagents.
REAGENTS
CaCal-o-trol CD contains human erythrocytes, mammalian leukocytes and platelets in a plasma-like fluid. Cal-o-trol CD is for in vitro diagnostic use.
PRECAUTIONS
WARNING: POTENTIAL HAZARDOUS MATERIAL.
Cal-o-trol CD is intended solely for in vitro diagnostic use by trained, qualified personnel. Human blood components used in Cal-o-trol CD were found to be non-reactive for HBsAg and antibody to HIV-1, HIV-2 and HCV when testing with licensed reagents. No known test methods can provide complete assurance that products derived from human blood will not transmit infectious diseases. Follow the same precautions as with patient samples when handling or disposing of vials. Do not inject or consume by mouth. Avoid direct mouth pipetting of samples.
STORAGE AND STABILITY
Open vial stability is 7 days, provided the vials are handled properly. The vials must be mixed according to instructions before each sampling and should be stored, tightly capped, at 2-8° C when not in use. See Instructions for Use section for detailed handling directions. Unopened vials stored continuously at 2-8° C are stable until the expiration date.
INDICATIONS OF DETERIORATION
Discoloration of the supernatant fluid may be caused by overheating or freezing during shipment or storage. Examine vials for excess hemolysis. Test the vials using reference methods if deterioration is suspected.
INSTRUMENTATION
Cal-o-trol CD can be used to calibrate the WBC, RBC, HGB, MCV/HCT, and PLT parameters on the Cell-Dyn hematology instrument models listed on the assay sheet.
INSTRUCTIONS FOR USE
CAUTION: IF THESE INSTRUCTIONS ARE NOT CAREFULLY FOLLOWED, CALIBRATION ERRORS MAY RESULT.
- Perform instrument set up/start up procedures according to the appropriate instrument Operator Reference Manual. Be sure instrument is clean and reagent containers have been checked.
- Mix a vial of Cal-o-trol CD as follows:
- a) Bring to room temperature by rolling the vial between the palms of the hands until the erythrocyte sediment is completely resuspended.
- b) Mix by gently inverting vial 8-10 times. Avoid vigorous shaking.
- c) IMPORTANT: DO NOT PLACE THE VIAL ON A ROTARY MIXER OR BLOOD TIPPER.
- d) After sampling, carefully wipe the vial rim and cap with lint-free gauze. Replace the cap immediately. Replace vial in refrigerator within 30 minutes of use. Store in an upright position.
- Aspirate Cal-o-trol CD. Verify calibration following the procedure in the instrument operator reference manual. If the WBC, RBC, HGB, MCV/HCT, and PLT values on all runs of Cal-o-trol CD are within the calculated acceptable range, recalibration is not necessary.
- If recalibration is required, refer to the instrument Operator Reference Manual.
- Verify calibration by processing a whole blood control sample such as Cal-o-trol CD through the instrument.
RESULTS
Refer to the assay table for the assigned value and acceptable range for each lot of Cal-o-trol CD. Verify that the lot number on the assay table corresponds with the lot number on the calibrator vial in use.
PERFORMANCE CHARACTERISTICS
Laboratories may consider results acceptable when at least 95 percent of patient test results from an instrument calibrated to Cal-o-trol CD are within 3 percent of values obtained on the patient sample using reference methods.
Cal-o-trol CD product integrity can be checked using the reference procedures listed below. Values recovered should be within the reference value acceptable range.
TECHNICAL ASSISTANCE-CUSTOMER SERVICE
Customers desiring technical assistance are encouraged to call our Technical Service Department at 02551/4090. For additional information on BGT hematology controls and Hematology Quality Control Program, call our Customer Service Department at 02551/4090.
REFERENCE METHODS
WBC and RBC: A large-volume, single-step dilution is made with calibrated glassware. Counts are performed on a single-aperture impedance cell counter and corrected for coincidence at all count levels.
HGB: Hemoglobin value is determined by spectrophotometric procedure according to NCCLS Standard H15-A2 and is traceable to ICSH/WHO International Haemiglobincyanide Standard.
HCT: Packed cell volume (PCV) is measured by the microhematocrit procedure according to NCCLS Standard H7-A2. No correction is made for trapped plasma.
MCV: MCV is calculated: PCV/RBC x 10.
PLT: Samples are diluted in I percent ammonium oxalate. Platelets are counted using a hemocytometer and phase contrast microscopy.
BIBLIOGRAPHY
- National Committee for Clinical Laboratory Standards. Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood - Second Edition; Approved Standard. NCCLS document H15-A2. Villanova, PA, 1994.
- National Committee for Clinical Laboratory Standards. Procedure for Determining Packed Cell Volume by the Microhematocrit Method.; Approved Standard. NCCLS publication H7-A2. Villanova, PA, 1993.
- Henry, JB, ed. Clinical Diagnosis and Management by Laboratory Methods. 18th ed. Philadelphia, W.B. Saunders Co., 1991.
- Van Assendelft, OW and England, MB. Advances in Hernatological Methods: The Blood Count. Boca Raton, FL, CRC Press, Inc., 1982.
TRADEMARKS
Cell-Dyn is a registered trademark of Unipath Corporation, Mountain View, CA 94043.
You can find the newest assay sheets for Cal-o-trol CD on the web www.assaysheet.com.
