Intended Use; Warning And Precautions - Beckman Coulter IM3632 Manual De Instrucciones

Stem-Trol Control Cells
IM3632
For In Vitro Diagnostic Use

INTENDED USE

Stem-Trol Control Cells is an assayed quality control product for immunophenotyping analysis using CD45 and /
or CD34 monoclonal antibodies reagents and flow cytometry. It provides a positive cell control that is processed
in the same manner as a blood specimen when Stem-Trol Control Cells are spiked into a peripheral whole blood
sample. This allows verification of reagent performance and the methods used for staining targeted cells (i.e.
CD34+ Hematopoietic Progenitor Cells HPC), lysing erythrocytes, and analyzing samples with flow cytometry.
Refer to the Stem-Kit Reagents (Ref. IM3630) package insert for complete instructions if performing manual
analysis. Refer to the stemCXP System Guide provided with the stemCXP System Software for complete
instructions if using the automated analysis.
SUMMARY
Immunophenotyping analysis using flow cytometry involves the identification and enumeration of targeted cells
in biological specimens. The specimens of interest are stained with monoclonal antibodies and erythrocytes are
lysed prior to flow cytometric analysis. A positive cell control is required to verify reagent performance, sample
preparation methods, and staining procedures (1). A positive cell control should mimic a representative targeted
cell in terms of monoclonal antibody performance, erythrocytes lysing, and flow cytometric analysis.
Stem-Trol Control Cells is a liquid preparation of stabilized KG-1a derived cells that have antigen expression and
CD45 and CD34 staining properties representative of those found on CD34+ HPC.
PRINCIPLE
Stem-Trol Control Cells are preserved KG-1a cells that have been modified and stabilized to express the CD34
class III epitopes (2) and the CD45 leukocyte common antigen at densities that approximate normal immature
human hematopoietic cells. A mixture of Stem-Trol Control Cells spiked into normal fresh whole blood is first stained
with the monoclonal antibody reagents and 7-AAD Viability Dye and then lysed to remove erythrocytes. Stem-Count
or Flow-Count Fluorospheres are added for the direct determination of absolute counts. Flow cytometric analysis
of the stained and lysed preparation determines the absolute count of the targeted cells. Expected results are
determined using Stem-Kit Reagents on validated and standardized FC500 flow cytometer systems equipped with
CXP System Software (Version 2.0) to analyze samples.
REAGENTS
Stem-Trol Control Cells is suspended in an isotonic solution, containing stabilizers and BSA. The Assayed Cell
concentration (cells/µL) is derived from multiple replicate analyses using the reference method. The specific value
is located on the vial label.

WARNING AND PRECAUTIONS

1. Specimens, samples, and all material coming in contact with them should be handled as if capable of
transmitting infection and disposed of with proper precautions.
2. Never pipet by mouth and avoid contact of specimens or reagents with skin and mucosa.
3. Do not use reagent beyond expiration date on vial label.
4. Do not freeze reagents.
5. Do not expose reagent to heat during storage or use.
6. Avoid evaporation and leakage of reagent by capping vials tightly after use, or erroneous results may occur.
7. Stem-Trol Control Cells will settle over extended periods. Ensure that the cells are completely resuspended
before use. Avoid excessive mixing to minimize the formation of air bubbles. Do not pipette air bubbles or
erroneous results may occur.
8. Use a calibrated positive displacement or repeater pipet to dispense samples and Stem-Trol Control Cells, or
erroneous results may occur.
9. Use pipetting techniques recommended by the pipet manufacturer to ensure accurate and precise pipetting
of samples and Stem-Trol Control Cells, or erroneous results may occur.
10.Each lot of Stem-Trol Control Cells has a specific concentration of cells. Ensure the correct assayed
concentration is used when determining absolute count results.
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