BD Vacutainer® CPT™ Cell Preparation Tube with Sodium Citrate

Expected Normal Donor Study Results

(Using 4 mL Draw Capacity)

Table 1 shows the cell percentages obtained from 45 blood specimens from 32 normal healthy adults using the FICOLL™ HYPAQUE™ and the BD Vacutainer® CPT™ Tube cell separation methods. Recovery and Purity percentages were determined from the mean of duplicate values obtained using the Coulter Counter® Model S Plus IV. Viability percentages were determined by Acridine Orange/Ethidium Bromide staining(7). Red blood cell percentages were determined by hemocytometer count under a light microscope. Both viability and red blood cell contamination were single determinations for each specimen.

Table 1

Cell Percentages, BD Vacutainer® CPT™ (CPT) Citrate Tube Method and FICOLL™ HYPAQUE™ (FH) Method

PARAMETER		MEAN	SD	CV
Recovery*	CPT FH	71.7 80.9	10.5 8.5	14.7 10.5
Purity*
Total Mononuclear	CPT	98.0	1.8	1.8
Cells	FH	98.7	0.8	0.9
Lymphocytes	CPT FH	85.9 87.3	4.3 4.0	5.0 4.5
Monocytes	CPT FH	12.1 11.4	3.3 3.4	27.7 29.7
Viability	CPT FH	99.9 99.7	0.3 0.5	0.3 0.5
RBC Contamination	CPT FH	14.3 6.8	9.4 5.5	65.9 81.3
PMN Contamination	CPT FH	2.0 1.2	1.8 0.8	88.7 68.1

Footnotes:
• Recovery - Number of recovered mononuclear cells expressed as a % of the total number of mononuclear cells contained in the original whole blood sample.
• Purity - Number of mononuclear cells expressed as a % of the mononuclear cells (lymphocytes and monocytes) in the separated white blood cell fraction.
• Viability - Number of mononuclear cells expressed as a % of the total mononuclear cells recovered.
• RBC Contamination - Number of red blood cells expressed as a % of the number of separated cells.
• Granulocyte (PMN) Contamination - Number of granulocytes expressed as a % of the total number of separated white blood cells.
• MEAN - Arithmetic Average
• SD - Standard Deviation
• CV - Coefficient of Variation (%)
• (4 mL Draw Capacity, n = 45)
  Mean Blood Draw Volume = 3.83 mL (SD 0.08)
  Mean Absolute Mononuclear Cell Count Recovered = 6.54x106 cells per tube (SD 1.99x106)with a Range of 3.36 to 10.54 x 106 cells
• (8 mL Draw Capacity, n = 10)
  Mean Blood Draw Volume = 7.58 mL (SD 0.08)
  Mean Absolute Mononuclear Cell Count Recovered = 12.72x106 cells per tube (SD 4.64x106) with a Range of 7.02 to 21.44 x 106 cells.


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