Examples of expected results (.pdf)
KONTROLLBLOD 16
16 parameter whole blood reference control
Intended use
KONTROLLBLOD 16 is a hematology reference control used in monitoring determinations of blood cell values on cell counters.
Summary
Mean values and expected ranges for automated hematological parameters are indicated on the Chart of Expected Results. Clinical hematology laboratories require stabilized cellsuspensions and similar substances as a means of determining and monitoring these hematological parameters. When used daily, KONTROLLBLOD 16 provides a useful means of evaluating the accuracy and precision of instrument operation.
Principle
KONTROLLBLOD 16 should be handled in the same manner as a patient blood specimen. When analyzed on a properly calibrated instrument, KONTROLLBLOD 16 values will fall within the assay sheet’s indicated ranges. KONTROLLBLOD 16 uses fixed human and other red cells to simulate human leukocytes in this control, as they are more stable than human leukocytes. Human red blood cells and simulated platelet components are used in the other parameters. The use of stabilized blood cell preparations of this nature is an established procedure in monitoring determinations of automated blood cell values.
Reagents
KONTROLLBLOD 16 is a suspension of stabilized lysable human erythrocytes, platelet components and fixed red cells (to simulate white cells) in a medium containing preservatives.
Warnings and precautions
KONTROLLBLOD 16 is intended for IN VITRO DIAGNOSTIC USE ONLY. The human constituents of KONTROLLBLOD 16 have been found nonreactive for Human Immunodeficiency Virus, Hepatitis B Surface Antigen (HBsAg) and Hepatitis C Virus (HCV) using reagents licensed by the Food and Drug Administration’s Bureau of Biologics. However, as no test available can provide total assurance that specimens of human origin will not transmit infectious disease, this product should be handled with care and considered potentially capable of transmitting infectious disease.
Storage and stability
KONTROLLBLOD 16 should be stored at 2° – 8°C. DO NOT FREEZE. Store the vials in an upright position. KONTROLLBLOD 16 is guaranteed stable 21 days after opening when returned to the refrigerator after each use.
Indications of deterioration
When KONTROLLBLOD 16 values fall outside the ranges on the Chart of Expected Results, there may be a problem with the control, the reagents or the instrument. Should this occur, assay an unopened vial of KONTROLLBLOD 16. If the problem persists, contact your LABEX representative or call LABEX Technical Support at: +46 42 32 40 00 or by fax: +46 42 20 27 71.
Procedure
On automated instrumentation, make dilutions and run specimens according to the instrument manufacturer’s instructions for patient samples. For manual methods, refer to manual of clinical laboratory procedures.
Expected results
Both manual reference methods and replicate analysis of whole blood calibrated instrumentation are used in deriving the mean assay values for each parameter indicated. Azide-free reagents were used in analyzing KONTROLLBLOD 16. When azidecontaining reagents are used with KONTROLLBLOD 16, differences in MCV, HCT and MCHC can be expected. Reagent differences, maintenance, operating technique and calibration method may account for interlaboratory variation. Therefore, KONTROLLBLOD 16 assay values are a useful guideline for control, but not absolute assay for calibrating.
Limitation of product
As the white blood cell components of KONTROLLBLOD 16 are erythrocytes, the WBCs simulate size but not morphology. A differential analysis of white blood cells cannot be performed. The performance of this product is ensured only by proper storage and use as indicated above.