BD Vacutainer® CPT™ Cell Preparation Tube with Sodium Citrate

Performance Characteristics

(Using 4 mL Draw Capacity)

Table 2 shows the reproducibility of separated sample quality using the BD Vacutainer® CPT™ Tube system which was tested and compared to the FICOLL™ HYPAQUE™ method. Ten samples of one donor's blood were centrifuged and assayed in duplicate for each method. No final washing steps were performed. The samples were resuspended to approximately equal final volumes. Between Tube variation was calculated by differencing the mean of the duplicate readings for each Tube.

Table 2

Reproducibility Study: Recovery, Purity, Viability,Red Blood Cell (RBC) and Granulocyte (PMN) Contamination** for BD Vacutainer® CPT™ (CPT) Citrate Tube Method and FICOLL™ HYPAQUE™ (FH) Method

PARAMETER		Number	MEAN****	SD	CV%
Recovery*	CPT FH	9*** 10	70.3 82.6	9.7 5.5	13.8 6.7
Purity*
Total Mononuclear	CPT	10	98.3	0.6	0.6
Cells	FH	10	99	0.3	0.3
Lymphocytes	CPT FH	10 10	84.4 84.8	1.3 0.9	1.5 1.1
Monocytes	CPT FH	10 10	13.9 14.2	1.4 0.8	10.4 5.9
Viability	CPT FH	10 10	100 99.8	0.0 0.4	0.0 0.4
RBC Contamination	CPT FH	10 10	7.4 2.6	1.6 1.0	21.7 39.0
PMN Contamination	CPT FH	10 10	1.7 1.0	0.6 0.3	34.5 30.7

Footnotes:
****Recovery and Purity are based on the Mean of 2 readings.
****Parameters defined in Table 1
****Sample lost due to spillage, Recovery could not be calculated.
****Using an F-Statistic (2-tailed) at the 5% level, no significant difference was detected between the methods.
• MEAN - Arithmetic Mean
• SD - Standard Deviation
• CV - Coefficient of Variation (%)
• N - Number of Tubes

Table 3 shows the cell percentage obtained from 4 groups of 5 patients each, using the FICOLL™ HYPAQUE™ and the BD Vacutainer® CPT™ Tube cell separation methods. Recovery and purity percentage were determined from the mean of duplicate values obtained using the Coulter® STKR cell counting method. Viability percentages were determined by Acridine Orange/Ethidium Bromide staining(7).

Table 3

Results from Patient Sample Study

SAMPLE NUMBER	TOTAL MONONUCLEAR RECOVERY (%)		PURITY (%)		VIABILITY (%)
	CPT	FH	CPT	FH	CPT	FH
Leukemia
1 CLL	70.5	76.2	98.0	99.4	96.4	97.4
2 CLL	67.8	70.6	99.0	98.5	99.2	98.9
3 CLL	79.7	83.2	97.6	99.5	96.0	97.1
4 CLL	71.4	68.3	99.1	99.3	97.5	98.0
5 CLL	75.6	82.4	99.7	99.7	99.4	100.0
HIV Positive
6 HIV	62.1	67.3	98.4	97.8	98.5	98.0
7 HIV	59.0	63.7	97.4	98.3	100.0	99.5
8 HIV	68.3	65.6	99.2	96.9	99.2	100.0
9 HIV	63.9	73.0	98.2	97.9	99.3	100.0
10 HIV	70.7	74.8	99.2	98.5	97.2	99.4
Diabetics
11 DIAB	58.1	64.3	96.7	97.0	99.5	97.8
12 DIAB	66.4	72.3	98.9	99.3	98.9	99.6
13 DIAB	70.2	67.5	97.5	99.0	100.0	99.7
14 DIAB	64.9	70.7	98.5	96.5	99.7	98.2
15 DIAB	62.7	67.7	97.0	98.2	97.8	98.3
Auto Immune
16 SLE	62.3	64.5	96.4	95.7	97.5	99.0
17 SLE	60.5	63.4	97.0	96.3	99.2	97.3
18 SLE	65.6	62.3	95.7	96.9	96.5	99.0
19 RA	71.5	66.5	96.2	97.2	99.2	100.0
20 RA	69.5	75.6	95.7	97.0	98.9	99.2

Footnotes:
• CLL - Chronic Lymphocytic Leukemia
• HIV - Human Immunodeficiency Virus Positive
• DIAB - Type I Diabetes
• SLE - Systemic Lupus Erythematosis
• RA - Rheumatoid Arthritis
• Recovery, Purity, and Viability Parameters defined in Table 1

FICOLL is a trademark of Amersham Biosciences AB
HYPAQUE is a trademark of Amersham Health AS