BD Vacutainer® CPT™ Cell Preparation Tube with Sodium Heparin

Expected Normal Donor Study Results

Table 1 shows the cell percentages obtained from forty-two blood specimens from a total of twenty-nine normal apparently healthy adults using the FICOLL™ HYPAQUE™ and the BD Vacutainer® CPT™ Tube cell separation methods. Recovery and Purity percentages were determined from values obtained using the Coulter Counter® Model S + STKR cell counting method. Viability percentages were determined by Acridine Orange/Ethidium Bromide method. RBC percentages were determined by hemo-cytometer count under a light microscope. Results are obtained following the procedures recommended by the manufacturer.

Table 1

Cell Percentages, FICOLL™ HYPAQUE™ versus BD Vacutainer® CPT™ Tube Method (7)

	FICOLL™ HYPAQUE™ Method			VACUTAINER® CPT™ Tube Method
PARAMETER	AVG%	SD	CV	AVG%	SD	CV
Recovery	68.2	10.322	15.122	63.0	11.722	18.622
Purity
Total Mononuclear Cells	93.5	*	*	92.2	*	*
Lymphocytes	79.8	*	*	79.6	*	*
Monocytes	13.6	*	*	12.2	*	*
Viability	94.7	4.5	4.8	95.8	2.8	2.9
RBC Contamination	6.3	9.9	157.1	16.9	14.2	84.0
Granulocyte Contamination	6.5	*	*	8.2	*	*

Footnotes:
• *Regression analysis shows that the percent purity parameter is donor dependent, thus no independent values of standard deviation are appropriate.
• Average number of mononuclear cells (Lymphocytes & Monocytes) recovered per milliliter of whole blood for each method was:
    • Vacutainer® CPT™ 1.30x106 cells
    •FICOLL™ HYPAQUE™ 1.40x106 cells
• Recovery - # of recovered mononuclear cells expressed as a % of the # contained in the original whole blood sample.
• Purity - # of mononuclear cells expressed as a % of lymphocytes and monocytes in the separated white blood cells.
• Viability - # of viable mononuclear cells expressed as a % of the total # cells separated.
• RBC Contamination - # of red blood cells expressed as a % of the # of separated cells.
• Granulocyte - # of granulocytes expressed as a % of the total Contamination # of separated white blood cells.
• AVG - Mean Number
• SD - Standard Deviation
• CV - Coefficient of Variation


Coulter Counter is a registered trademark of Coulter International Corp.
FICOLL is a trademark of Amersham Biosciences AB
HYPAQUE is a trademark of Amersham Health AS