Produkte/Blutbildkontrollen/Cal-o-trol Plus für Mythic

Cal-o-trol Plus für Mythic

INTENDED USE
Cal-o-trol Plus for Mythic
is designed for use In the calibration of Orphée hematology analyzers. Please refer to the assay table for specific instrument models.


SUMMARY AND PRINCIPLE
Hematology analyzers require periodic calibration in order to generate accurate patient results. This calibrator is a stable, whole blood preparation that can be used to verify and adjust calibration of select hematology instruments.
Calibrator values for Cal-o-trol Plus for Mythic are derived from replicate testing on instruments operated and maintained according to the manufacturer's instructions, instruments are calibrated with whole blood using values determined by reference methods.


REAGENTS
Cal-o-trol Plus for Mythic
is an In vitro diagnostic reagent composed of human erythrocytes, mammalian leukocytes and mammalian platelets suspended In a plasma-like fluid with preservatives.


PRECAUTION
Cal-o-trol Plus for Mythic
Is intended for in vitro diagnostic use only by trained personnel.


WARNING:
POTENTIAL BIOHAZARDOUS MATERIAL. For In vitro diagnostic use. Each human donor/unit used In the preparation of this product has been tested by a FDA licensed method/test and found to be negative or non-reactive for the presence of HBsAg, Anti-HCV, NAT testing for HlV-1, HCV (RNA) and HIV-1/2. Each unit Is also negative by a serological test for Syphilis (RPR or STS). Because no test method can offer complete assurance that Infectious agents are absent, this material should be handled as potentially infectious. When handling or disposing of viais follow precautions for patient specimens as specified In the OSHA Bloodborne Pathogen Rule (29 CFR Part 1910,1030) or other equivalent biosafety procedures.


STABILITY AND STORAGE

Store Cal-o-trol Plus for Mythic upright at 2 - 8° C (35-46° F) when not in use. Protect tubes/vials from overheating and freezing. Unopened tubes/vtals are stable through the expiration date. Opened tubes/vials are stable for 7 days, provided they are handled properly.


INDICATIONS OF DETERIORATION
After mixing, product should be similar in appearance lo fresh whole blood. In unmixed tubes/vials, the supernatant may appear cloudy and reddish; this Is normal and does not Indicate deterioration. Other discoloration, very dark red supernatant or unacceptable results may Indicate deterioration. Do not use the product if deterioration is suspected.


INSTRUCTIONS FOR USE

A. Mixing and handling directions:

  1. Remove tubss/vlals from the refrigerator and allow to warm at room temperature (15 - 30°C or 59 - 86°F) for 15 minutes before mixing.
  2. To mix, hold a tube/vial horizontally between the palms of the hands. Do not pre-mlx on a mechanical mixer.
    a) Roll the tube/vlal back and forth for 20 - 30 seconds; occasionally invert the tube/vial. Mix vigorously but do not shake.
    b) Continue to mix In this manner until the red cells are completely suspended. Tubes/vials stored for a long time may require extra mixing.
    c) Gently invert the tube/vial 8-10 times immediately before running each sample.
  3. After sampling:
    a) Automatic Sample Handling: Remove the tube/vlal from the sample handler immediately after sampling.
    b) Manual Sample Handling: Carefully wipe the tube/vial rim and cap with a lint-free tissue and replace the cap.
  4. Return tubes/vials to refrigerator within 30 minutes of use.

B. Analyze Calibrator:

  1. Prime the Instrument once by aspirating calibrator sample. Discard the result.
  2. Analyze calibrator according lo the calibralion procedure in the Operator's Manual for your instrument.
  3. Compare the mean value for each parameter tothe assigned value.
    a) If the difference Is within the Acceptable Range, calibration is optional.
    b) If the difference is not within the Acceptable Range, calibration may be needed.
  4. Acceptable Ranges given on the assay sheet are Intended as guidelines, but not absolute limits, for evaluating Instrument calibration. Acceptable calibration should be established by each laboratory.

C. Adjust instrument calibration and verify results:

  1. Calibrate the instrument by using ihe calibration adjustment procedures described in the Operator's Manual for your Instrument.
  2. Verify calibration by analyzing calibrator and repeat step 3 under "Analyze Calibrator".


EXPECTED RESULTS
Verify that the tot number on the tube/viai matches the lot number on the table of assay values. Assay values are determined on wel-maintalned, properly calibrated instruments using the instrument manufacturer's recommended reagents.


REFERENCE METHODS

  1. WBC: A series of 1:500 dilutions are made with calibrated glassware. Counting is performed on a Coulter Counter Z series instrument. All counts are corrected for coincidence
  2. RBC: A series of 1:50,000 dilutions are made with calibrated glassware. Counting is performed on a Coulter Counter Z series instrument. All counts are corrected for coincidence
  3. HGB: Hemoglobin value Is determined byspectrophotometric procedure according to NCCLS Standard H15-A3 and is traceable to 1CSH/WHO International Haemiglobincyanide Standard.
  4. HCT: Packed cell volume (PCV) is measured by the mlcrohematocrit procedure according to NCCLS Standard H7-A3. No correction Is made for trapped plasma.
  5. PLT: A series of 1:125 dilutions are made using calibrated glassware in 1% ammonium oxalate. Platelets are counted using a hemocytometer and phase contrast microscopy.


LIMITATIONS
The performance of this product is assured only if it is property stored and used as described in this insert. Incomplete mixing of a tube/vial prior to use Invalidates both the sample withdrawn and any remaining material in the tube/vial.


TECHNICAL ASSISTANCE AND CUSTOMER SERVICE
For assistance in resolving control recovery problems, please call the BGT technical service at 02551/4090.
For additional information on BGT hematology controls and calibrators, or to place an order, call the BGT's Customer Service at 02551/4090.

All brands and products are trademarks or registered trademarks of their respective companies.

Aktuelle Werteblätter für Cal-o-trol Plus für Mythic finden Sie auf www.werteblatt.de.


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img/page/needfull/ce-zeichen.gif Hersteller:

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Von-Langen-Weg 10
D-48565 Steinfurt
Tel.: 02551/4090  Fax.: 02551/1298
Web: www.biogentechnologies.de



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EN ISO 13485:2003