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An intralaboratory quality control program for quantitation of CD34+ cells by flow cytometry
T J Farley1, W Rooney, E Kuhns
1New York Blood Center, Clinical Services, Valhalla, USA.
Journal of Hematotherapy
|August 1, 1997
Summary
Developing a quality control protocol using cryopreserved peripheral blood progenitor cells (PBPCs) ensures reliable CD34 analysis. This method enhances assay accuracy and identifies potential issues in instrument or operator performance.
Area of Science:
- Hematology
- Clinical Laboratory Science
- Immunophenotyping
Background:
- Accurate CD34+ cell enumeration is critical for hematopoietic stem cell transplantation.
- Standardized quality control (QC) is essential for reliable instrument and assay performance.
Purpose of the Study:
- To develop and validate a dual-level quality control protocol for CD34 assay performance.
- To assess the suitability of cryopreserved peripheral blood progenitor cells (PBPCs) as control materials.
Main Methods:
- Cryopreservation of PBPC aliquots with varying CD34+ cell percentages.
- Assay of 25 samples per control specimen to establish control ranges (mean +/- 2 SD).
- Utilizing Levey-Jennings graphs for monitoring CD34+ measurements over time.
Main Results:
- No significant differences in light scatter or CD34 antigen density between fresh and cryopreserved PBPCs.
- Established control ranges using cryopreserved PBPC samples.
- Demonstrated the stability of cryopreserved PBPCs for QC purposes.
Conclusions:
- Cryopreserved PBPC samples are effective positive controls for daily CD34 analysis.
- The developed QC protocol can identify issues with reagents, sample preparation, or data analysis.
- This system improves the reliability of CD34 enumeration in clinical laboratories.