Solastra Tech Spec Sheet Brochure

• CE-IVD-Marked ‡

• Bethesda 2006 International Consensus-Aligned

• WHO 2008-Revised Classification-Compatible

• 5-Color, 7-Combination, 23-Marker Panel

• Pre-mixed, Optimized, Comprehensive Cocktails

• Provide Standardization, Consistency and Simplicity

Blood BankingCapillary Electrophoresis

Cell AnalysisCentrifugation

GenomicsLab Automation

Lab ToolsParticle Characterization

Solastra™ Lineage Panel

Experience simplicity and consistencyin multiparametric flow cytometry

P RODUC T OV ER V IE W

Flow cytometric analyses are an integral part of the stan-dard of care in hematopathology. The Solastra 5-Color Reagent Panel is a comprehensive CE-marked ‡ panel of conjugated-antibody cocktails for the characterization of hematolymphoid neoplasia by flow cytometry. These products are intended for identification and enumeration of relevant leukocyte surface molecules and are useful as an aid in differential diagnosis of patients with certain abnormal hematology results and/or presence of blasts in the blood stream, bone marrow and/or lymphoid tissues. The Solastra 5-Color Reagents are composed of antibodies directed to B, T, and Myelomonocytic lineage antigens and reflect the minimum number of markers recommended by the 2006 Bethesda International Consensus conference published conclusions (1, 2).

M A R K ERS

The following markers are included in the kits, respectively:• B Lineage Kit: CD45, CD5, CD10, CD19, CD20,

CD38, Kappa and Lambda• T Lineage Kit: CD45, CD2, CD3, CD4, CD5, CD7,

CD8 and CD56• Myelomonocytic Lineage Kit: CD45, CD7, CD11b,

CD13, CD14, CD15, CD16, CD33, CD34, CD56, CD117 and HLA-DR

MARKER CLONE REACTIV ITYCD2 39C1.5

IgG2a (rat)T cells and most of the NK cells

CD3 UCHT1IgG1 (mouse)

Mature T cell (cytoplasmic expres-sion in immature T cells)

CD4 SFCI12T4D11IgG1 (mouse)

Helper / inducer T cells, monocytes, immature myeloid cells

CD5 BL1aIgG2a (mouse)

Thymocytes, mature T cells, subpo-pulation of B cells

CD7 8H8.1IgG2a (mouse)

T cells, NK cells, subpopulation of immature myeloid cells

CD8 SFCI21Thy2D3IgG1 (mouse)

Cytotoxic / suppressor T cells, sub-population of NK cells

CD10 ALB1IgG1 (mouse)

Common acute leukemia antigen (CALLA), lymphatic precursor cells, neutrophils, subpopulation of mature B cells

CD11b Bear1IgG1 (mouse)

Monocytes, macrophages, neu-trophils, NK cells

CD13 366 (MY7)IgG1 (mouse)

Myeloid cells

CD14 RMO52IgG2a (mouse)

Monocytes, weak expression on neutrophils

CD15 80H5IgM (mouse)

Neutrophils, weak expression on monocytes

CD16 3G8IgG1 (mouse)

NK cells, neutrophils, subpopulation of monocytes

CD19 J3-119IgG1 (mouse)

Precursor and mature B cells

MARKER CLONE REACTIV ITYCD20 B9E9

IgG2a (mouse)B cells and a subpopulation of B precursor cells

CD33 D3HL60.251IgG1 (mouse)

Monocytes, myeloid precursor cells, weak on neutrophils

CD34 581IgG1 (mouse)

Myeloid and lymphoid precursor cells

CD38 LS198-4-3IgG1 (mouse)

Activated lymphocytes, subpopula-tion of B cells, plasma cells

CD45 J.33IgG1 (mouse)

All leukocytes

CD56 N901IgG1 (mouse)

NK cells, subpopulation of T cells

CD117 104D2D1IgG1 (mouse)

Myeloid precursor cells

HLA-DR Immu-357IgG1 (mouse)

B cells, activated T cells, monocytes, precursor cells

Kappa N/A: Polyclonal Kappa light chain

Lambda N/A: Polyclonal Lambda light chain

P RODUC T S

The three Beckman Coulter Solastra products (T-, B- and Myelomonocytic-Lineage Kits) consist of 7 pre-mixed, CE-IVD, 5-color cocktails. A total of 23 markers are included as directly conjugated antibodies. As recommended in the Bethesda International Consensus, CD45 is present in each combination for gating purposes. Dual parameter histograms gated on the selected CD45 vs. Side Scatter populations are then used to determine positively stained cells for each of the surface antigens recognized by the antibodies within the kits.

SOL A S T R A 5 - C OLOR K I T S A ND C OM B I N AT ION S

PN PANEL TUBE FITC PE ECD PC5.5 PC7

A66286∆ Solastra B Lineage Kit

BL1 Kappa Lambda CD19 CD5 CD45BL2 CD20 CD10 CD19 CD38 CD45

A66287∆ Solastra T Lineage Kit

TL1 CD2 CD56 CD7 CD5 CD45TL2 CD8 CD4 - CD3 CD45

A66288∆ Solastra Myelomo-nocytic Lineage Kit

ML1 CD15 CD11b CD16 CD14 CD45ML2 HLA-DR CD56 CD34 CD117 CD45ML3 CD7 CD13 CD34 CD33 CD45

S TOR AG E C OND I T ION S A ND S TA B I L I T Y:

Closed vial stability: 9 months maximum after date of manu-facturing when stored in standard laboratory refrigerators, i.e. at 2 – 8°C. Do not freeze. Opened vials are stable for 90 days, provided that care is taken to minimize exposure to light and return to 2 – 8°C immediately after use.

originalet.indd 2 10-06-18 15.23.14



M A R K ERS






















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R E AG EN T S R EQU IR ED BU T NOT SU P P L I ED

• VersaLyse™ Lysing Solution, PN A09777• IOTest® 3 Fixative Solution, PN A07800• Flow-Check™ Pro Fluorospheres, PN A63493• Flow-Set™ Pro Fluorospheres, PN A63492• Solastra QuickCOMP 5 Kit, PN A83571¤

or QuickCOMP 4 Kit (except for CD45-PC5), PN 177017, with CD45-PC5.5, PN A62835, and CD45-PC7, PN IM3548

• Phosphate Buffered Saline (PBS), PN 6603369• Heat-Inactivated Fetal Calf Serum (HIFCS)• Heat-Inactivated Mouse Serum (HIMS) (facultative)

F LOW CY TOME T ERS A ND F L UOROC H ROME S :

Solastra is well adapted to Beckman Coulter Cytomics FC 500 Flow Cytometers, capable of simultaneous 5-color analysis from a single 488 nm laser line. Fluorochromes are usable without filter change on the FC 500 configured with the standard IVD application filter set for 5-color single laser analysis. If necessary, optical bench can be adapted to the PC5.5 fluorochrome emission spectrum by using the following devices: Single Laser Filter Kit for FC 500 flow cytometer, PN 179044 or Single Laser Filter Block Assembly for FC 500 flow cytometer, PN 179045.

FLUOROCHROME PRIMARY EXCITATION (nm)

MAXIMUM EMISSION (nm)

FITC 468-509 504-541PE 486-580 568-590ECD 486-580 610-635PC5.5 486-580 680-710PC7 486-580 750-790

IN S T R U MEN T SE T T ING S :

Users should refer to the instrument’s manuals for speci-fic instructions for setting PMT voltages and fluorescence compensation prior to analysis; autostandardization and compensation are to be done with CXP software, using Flow-Check Pro Fluorospheres, Flow-Set Pro Fluorospheres, and fluorochrome matched CD45 conjugates.

SP EC IMEN C OL L EC T ION :

• Each flow cytometric analysis requires 100 µL of whole blood, bone marrow or single lymphoid cell suspension (specimens should be with white blood cell counts in the range of 2-20 x 103 cells/µL).

• Whole Blood and bone marrow may be collected using EDTA, Heparin or ACD anticoagulants as appropriate for the specimen.

• EDTA collected specimens stained with Solastra Rea-gents may be prepared within 24 hours. Analysis of samples must be performed on the same day as sample staining. Specimens collected with Heparin or ACD may be prepared within 48 hours of collection. Analysis of samples must be performed on the same day as sample staining.

SP EC IMEN P R EPA R AT ION :

A pre-wash procedure is required to optimize the staining of Kappa- and Lambda-Light Chains on cell surface. It is generalized to the whole panel with the aim to standardize the preparation and staining procedures. Freedom is given to the user to choose a “bulk wash” procedure where the totality of the specimen is washed at once, or a classical “single tube wash” procedure, where specimen aliquots are washed separately.











All leukocytes









P RODUC T S


SOL A S T R A 5 - C OLOR K I T S A ND C OMB IN AT ION S










R E AG EN T S R EQU IR ED BU T NOT S U P P L I ED








FITC 468-509 504-541PE 486-580 568-590ECD 486-580 610-635PC5.5 486-580 680-710PC7 486-580 750-790



















All leukocytes









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FITC 468-509 504-541PE 486-580 568-590ECD 486-580 610-635PC5.5 486-580 680-710PC7 486-580 750-790












M A R K ERS






















Myeloid cells


















All leukocytes









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SOL A S T R A 5 - C OLOR K I T S A ND C OM B IN AT ION S













M A R K ERS






















Myeloid cells


















All leukocytes









P RODUC T S


SOL A S T R A 5 - C OLOR K I T S A ND C OMB IN AT ION S




















All leukocytes









P RODUC T S




















FITC 468-509 504-541PE 486-580 568-590ECD 486-580 610-635PC5.5 486-580 680-710PC7 486-580 750-790










BU L K WA SH P ROC EDU R E

1. Obtain WBC count of the sample.2. Add 1.0 mL whole blood or bone marrow specimen

to a 15 mL conical centrifuge tube.3. Add no less than 9.0 mL of the PBS / 2% FCS wash

buffer (1:10 dilution is critical). Mix by gentle inversion.

4. Centrifuge at 150 x g for 10 minutes at room tempe-rature (20 – 25°C).

5. Aspirate (do not decant) and discard supernatant.

6. Repeat steps 3-5 two additional times.7. Resuspend the washed pellet in either PBS / 2%

HIFCS or PBS / 50% HIMS with an appropriate vo-lume to obtain a WBC count of 2-20 x 103 cells/µL.

8. Proceed to Staining Procedure.

OR : S ING L E T U BE WA SH P ROC EDU R E

1. Obtain WBC count of the sample. a. If the WBC count is above 20 x 103 cells/µL, di-

lute sample appropriately with the PBS/2% FCS wash buffer.

b. If the WBC count is <2 x 103 cells/µL, the sample must be concentrated prior to washing.

2. For each sample add 100 µL of whole blood or bone marrow specimen to three 12 x 75 mm test tubes labe-led for each of the Solastra Lineage Reagents used.

3. Add 3.0 mL of the PBS/2% FCS wash buffer. Mix by gentle inversion.

4. Centrifuge at 1000 x g for 2 minutes.5. Aspirate and discard supernatant.6. Repeat steps 3-5 two additional times.7. Resuspend the washed pellet in either PBS / 2%

HIFCS or PBS / 50% HIMS to the initial 100 µL vo-lume.

8. Proceed to Staining Procedure, Step 3.

S TA IN ING P ROC EDU R E : 1. For each sample washed using the Bulk Wash

Procedure, and for the single cell suspensions of lymphoid tissues, label individual 12 x 75 mm test tubes. For samples washed using the Single Tube Wash Procedure, proceed to Step 3.

2. Add 100 µL of the sample to each test tube.3. Add 20 µL of Solastra reagents to the corresponding

labeled test tube. Vortex gently.4. Incubate the reaction mixtures at 20-25°C for 15-20

minutes. Protect from light.5. Lyse the red blood cells in each test tube

NOTE: Single cell suspensions from lymphoid tis-sues do not require the red blood cell lysis. Proceed to step e.

a. Add 1 mL of the VersaLyse “Fix-and-Lyse” mixture to each test tube and vortex imme-diately for 1 second.

b. Incubate at least 10 minutes at room tempe-rature (20 – 25°C), protected from light.

c. Centrifuge for 5 minutes at 150 x g at room

temperature. d. Remove the supernatant by aspiration. e. Resuspend the cell pellet in 3 mL of PBS. f. Centrifuge for 5 minutes at 150 x g at room

temperature. g. Remove the supernatant by aspiration and

resuspend the cell pellet in 0.5 mL of 0.1% formaldehyde PBS buffer.

h. To minimize the possibility of less than opti-mal results, analyze stained cells promptly.

6. Analyze cells on a flow cytometer properly standar-dized and gated on each population of interest.

LOW ER L IM I T OF DE T EC T ION :

A study was conducted in accordance with CLSI Approved Guidelines (4). Results support a lower limit of detection of 0.3% when collecting 50,000 events.

E X P EC T ED VA L U E S :

These are intended as representative values only. Each laboratory should establish its own expected values from the local population of normal donors.

SOL A S T R A B L IN E AG E K I T / NOR M A L W HOL E BLOOD :

MEASUREMENT N MEAN INTERVAL

LOWER UPPER

% Lymphocytes

CD19+ (BL1 Tube) 127 10.90 2.98 20.28

CD19+ (BL2 Tube) 127 11.06 2.87 21.43

CD20+ 127 10.87 2.85 21.41

CD5+ 130 79.40 63.10 93.27

% CD19+ B Lymphocytes

CD19+Kappa+ 83 58.24 43.33 75.95

CD19+Lambda+ 83 38.55 30.42 47.55

% Monocytes

CD38+ 130 95.25 79.19 99.66

% Granulocytes

CD10+ 129 93.73 70.94 99.96








































LOWER UPPER

% Lymphocytes

CD19+ (BL1 Tube) 127 10.90 2.98 20.28

CD19+ (BL2 Tube) 127 11.06 2.87 21.43

CD20+ 127 10.87 2.85 21.41

CD5+ 130 79.40 63.10 93.27


CD19+Kappa+ 83 58.24 43.33 75.95

CD19+Lambda+ 83 38.55 30.42 47.55

% Monocytes

CD38+ 130 95.25 79.19 99.66

% Granulocytes

CD10+ 129 93.73 70.94 99.96











All leukocytes









P RODUC T S




















FITC 468-509 504-541PE 486-580 568-590ECD 486-580 610-635PC5.5 486-580 680-710PC7 486-580 750-790










B U L K WA SH P ROC EDU R E









OR : S I NG L E T U BE WA SH P ROC EDU R E





























LOWER UPPER

% Lymphocytes

CD19+ (BL1 Tube) 127 10.90 2.98 20.28

CD19+ (BL2 Tube) 127 11.06 2.87 21.43

CD20+ 127 10.87 2.85 21.41

CD5+ 130 79.40 63.10 93.27


CD19+Kappa+ 83 58.24 43.33 75.95

CD19+Lambda+ 83 38.55 30.42 47.55

% Monocytes

CD38+ 130 95.25 79.19 99.66

% Granulocytes

CD10+ 129 93.73 70.94 99.96








































LOWER UPPER

% Lymphocytes

CD19+ (BL1 Tube) 127 10.90 2.98 20.28

CD19+ (BL2 Tube) 127 11.06 2.87 21.43

CD20+ 127 10.87 2.85 21.41

CD5+ 130 79.40 63.10 93.27


CD19+Kappa+ 83 58.24 43.33 75.95

CD19+Lambda+ 83 38.55 30.42 47.55

% Monocytes

CD38+ 130 95.25 79.19 99.66

% Granulocytes

CD10+ 129 93.73 70.94 99.96


REPRESENTAT IVE RESULTS :

Example of a mature B-cell neoplasm bone marrow aspirate sample.

• Figure 1 (upper left): CD45-PC7 vs. SS Histogram (Ungated). Gate Lymph displays a large CD45bright lymphocytic population.

• Figure 2 (middle): Tube BL1 gated on Leukocytes (Gate WBC).• Figure 3 (lower right): Tube BL1 gated on CD19+ lymphocytes (Gate CD19+ Ly).• Figure 4 (right): Tube BL2 gated on Lymphocytes (Gate CD19+ Ly).


REPRESENTAT IV E RESULTS :











































LOWER UPPER

% Lymphocytes

CD19+ (BL1 Tube) 127 10.90 2.98 20.28

CD19+ (BL2 Tube) 127 11.06 2.87 21.43

CD20+ 127 10.87 2.85 21.41

CD5+ 130 79.40 63.10 93.27


CD19+Kappa+ 83 58.24 43.33 75.95

CD19+Lambda+ 83 38.55 30.42 47.55

% Monocytes

CD38+ 130 95.25 79.19 99.66

% Granulocytes

CD10+ 129 93.73 70.94 99.96


SOL A S T R A T L IN E AG E K I T / NOR M A L W HOL E BLOOD :


LOWER UPPER

% Lymphocytes

CD2+ 130 85.24 72.63 95.35

CD5+ 130 78.65 61.42 88.13

CD7+ 130 81.53 69.74 91.04

CD56+ 130 14.38 3.97 32.34

CD3+ 130 77.82 62.42 88.43

CD3+CD4+ 130 49.52 17.61 70.19

CD3+CD8+ 130 26.68 12.01 52.40

SOL ASTR A MYELOMONOCY T IC L INE AGE K IT / NORMAL WHOLE BLOOD :


LOWER UPPER

% Lymphocytes

CD7+ 130 81.01 65.80 92.79

CD56+ 129 14.39 4.03 32.92

% Granulocytes

CD11b+ 130 99.66 97.58 100.00

CD13+ 129 99.41 92.36 100.00

CD15+ 130 99.68 97.55 99.99

CD16+ 130 95.48 84.59 99.68

% Monocytes

CD14+ 129 96.94 90.18 99.46

CD33+ 129 97.90 90.73 99.70

HLA-DR+ 130 98.40 88.69 99.95

P R EC I S ION :

The percent positive values were determined using IM-MUNO-TROL™ (or, as necessary, IMMUNO-TROL with Stem-Trol™ Control Cells, and IMMUNO-TROL with MO7E cell line), run in duplicate, twice each day for up to 20 days at 4 geographically diverse sites using the Solastra B, T and Myelomonocytic Lineage Kit reagents.

SOL A S T R A B L IN E AG E K I T

MEASUREMENT REPEATABILITY(CV %)

MEAN

% Lymphocytes

CD19+ (BL1 Tube) 2.80% 14.20

CD19+ (BL2 Tube) 2.74% 14.34

CD20+ 3.56% 14.78

CD5+ 1.04% 71.86

% CD19 B Lymphocytes

CD19+Kappa+ 2.91% 57.42

CD19+Lambda+ 4.06% 40.23

% CD38 Monocytes

CD38+ 0.89% 94.45

% CD10+ Granulocytes

CD10+ 0.03% 99.96

SOL A S T R A T L IN E AG E K I T


MEAN

% Lymphocytes

CD2+ 0.67% 81.78

CD5+ 0.93% 72.73

CD7+ 0.73% 74.65

CD56+ 3.32% 13.76

CD3+ 0.76% 71.16

CD3+CD4+ 1.24% 45.48

CD3+CD8+ 1.94% 22.67

SOL A S T R A M Y E LOMONOC Y T IC L IN E AG E K I T


MEAN

% Lymphocytes

CD7+ 1.59% 73.88

CD56+ 7.34% 14.16

% Granulocytes

CD11b+ 2.34% 97.26

CD13+ 0.43% 99.91

CD15+ 0.20% 99.76

CD16+ 0.56% 94.56

% Monocytes

CD14+ 0.91% 89.35

CD33+ 0.94% 95.44

HLA-DR+ 0.56% 95.20

% Stem-Trol Population

CD34+ (ML2 Tube) 9.26% 11.85

CD34+ (ML3 Tube) 7.00% 11.75

% MO7E Cell Line Population

CD117+ 9.23% 13.89




LOWER UPPER

% Lymphocytes

CD2+ 130 85.24 72.63 95.35

CD5+ 130 78.65 61.42 88.13

CD7+ 130 81.53 69.74 91.04

CD56+ 130 14.38 3.97 32.34

CD3+ 130 77.82 62.42 88.43

CD3+CD4+ 130 49.52 17.61 70.19

CD3+CD8+ 130 26.68 12.01 52.40



LOWER UPPER

% Lymphocytes

CD7+ 130 81.01 65.80 92.79

CD56+ 129 14.39 4.03 32.92

% Granulocytes

CD11b+ 130 99.66 97.58 100.00

CD13+ 129 99.41 92.36 100.00

CD15+ 130 99.68 97.55 99.99

CD16+ 130 95.48 84.59 99.68

% Monocytes

CD14+ 129 96.94 90.18 99.46

CD33+ 129 97.90 90.73 99.70

HLA-DR+ 130 98.40 88.69 99.95

P R EC I S ION :




MEAN

% Lymphocytes

CD19+ (BL1 Tube) 2.80% 14.20

CD19+ (BL2 Tube) 2.74% 14.34

CD20+ 3.56% 14.78

CD5+ 1.04% 71.86


CD19+Kappa+ 2.91% 57.42

CD19+Lambda+ 4.06% 40.23

% CD38 Monocytes

CD38+ 0.89% 94.45


CD10+ 0.03% 99.96



MEAN

% Lymphocytes

CD2+ 0.67% 81.78

CD5+ 0.93% 72.73

CD7+ 0.73% 74.65

CD56+ 3.32% 13.76

CD3+ 0.76% 71.16

CD3+CD4+ 1.24% 45.48

CD3+CD8+ 1.94% 22.67

SOL A S T R A M Y E LOMONOC Y T IC L IN E AG E K I T


MEAN

% Lymphocytes

CD7+ 1.59% 73.88

CD56+ 7.34% 14.16

% Granulocytes

CD11b+ 2.34% 97.26

CD13+ 0.43% 99.91

CD15+ 0.20% 99.76

CD16+ 0.56% 94.56

% Monocytes

CD14+ 0.91% 89.35

CD33+ 0.94% 95.44

HLA-DR+ 0.56% 95.20


CD34+ (ML2 Tube) 9.26% 11.85

CD34+ (ML3 Tube) 7.00% 11.75


CD117+ 9.23% 13.89




Lambda - PE

Kap

pa

- FI

TC

100

100 101 102 103

101

102

103

010

23

100 101 102 103

CD19 - ECD

SS

Lin

100

100 101 102 103

101

102

103

010

23

100 101 102 103

CD45 - PC7

SS

Lin

100

100 101 102 103

101

102

103

010

23

100 101 102 103

CD45 - PC7

CD34 - ECD

CD7 - ECD

SS

Lin

CD45 - PC7

SS

Lin

CD

117

- P

C5.

5

CD

2 -

FITC

Example of a precursor T-cell lymphoblastic leukemia / lymphoma (T-ALL/LBL) bone marrow sample.

• Figure 4 (above): CD45-PC7 vs. SS Histogram (Ungated). Gate CD45dimSSlow displays a large CD45dim popula-tion.

• Figure 5 (below): Tube TL1 displaying CD45dim/SSlow

gated events.

Example of an acute myeloid leukemia (AML) bone mar-row sample.

• Figure 6 (opposite): CD45-PC7 vs. SS Histogram (Unga-ted). Gate CD45dimSSlow displays a large CD45dim popu-lation.

• Figure 7 (above): Tube ML2 displaying CD45dim/SSlow gated events.


Example of a precursor T-cell lymphoblastic leukemia / lymphoma (T-ALL/LBL) bone marrow sample.

• Figure 4 (above): CD45-PC7 vs. SS Histogram (Ungated). Gate CD45dimSSlow displays a large CD45dim popula-tion.

• Figure 5 (below): Tube TL1 displaying CD45dim/SSlow

gated events.

Example of an acute myeloid leukemia (AML) bone mar-row sample.

• Figure 6 (opposite): CD45-PC7 vs. SS Histogram (Unga-ted). Gate CD45dimSSlow displays a large CD45dim popu-lation.

• Figure 7 (above): Tube ML2 displaying CD45dim/SSlow gated events.




LOWER UPPER

% Lymphocytes

CD2+ 130 85.24 72.63 95.35

CD5+ 130 78.65 61.42 88.13

CD7+ 130 81.53 69.74 91.04

CD56+ 130 14.38 3.97 32.34

CD3+ 130 77.82 62.42 88.43

CD3+CD4+ 130 49.52 17.61 70.19

CD3+CD8+ 130 26.68 12.01 52.40



LOWER UPPER

% Lymphocytes

CD7+ 130 81.01 65.80 92.79

CD56+ 129 14.39 4.03 32.92

% Granulocytes

CD11b+ 130 99.66 97.58 100.00

CD13+ 129 99.41 92.36 100.00

CD15+ 130 99.68 97.55 99.99

CD16+ 130 95.48 84.59 99.68

% Monocytes

CD14+ 129 96.94 90.18 99.46

CD33+ 129 97.90 90.73 99.70

HLA-DR+ 130 98.40 88.69 99.95

P R EC I S ION :




MEAN

% Lymphocytes

CD19+ (BL1 Tube) 2.80% 14.20

CD19+ (BL2 Tube) 2.74% 14.34

CD20+ 3.56% 14.78

CD5+ 1.04% 71.86


CD19+Kappa+ 2.91% 57.42

CD19+Lambda+ 4.06% 40.23

% CD38 Monocytes

CD38+ 0.89% 94.45


CD10+ 0.03% 99.96



MEAN

% Lymphocytes

CD2+ 0.67% 81.78

CD5+ 0.93% 72.73

CD7+ 0.73% 74.65

CD56+ 3.32% 13.76

CD3+ 0.76% 71.16

CD3+CD4+ 1.24% 45.48

CD3+CD8+ 1.94% 22.67

SOL A S T R A M Y ELOMONOCY T IC L IN E AG E K I T


MEAN

% Lymphocytes

CD7+ 1.59% 73.88

CD56+ 7.34% 14.16

% Granulocytes

CD11b+ 2.34% 97.26

CD13+ 0.43% 99.91

CD15+ 0.20% 99.76

CD16+ 0.56% 94.56

% Monocytes

CD14+ 0.91% 89.35

CD33+ 0.94% 95.44

HLA-DR+ 0.56% 95.20


CD34+ (ML2 Tube) 9.26% 11.85

CD34+ (ML3 Tube) 7.00% 11.75


CD117+ 9.23% 13.89




LOWER UPPER

% Lymphocytes

CD2+ 130 85.24 72.63 95.35

CD5+ 130 78.65 61.42 88.13

CD7+ 130 81.53 69.74 91.04

CD56+ 130 14.38 3.97 32.34

CD3+ 130 77.82 62.42 88.43

CD3+CD4+ 130 49.52 17.61 70.19

CD3+CD8+ 130 26.68 12.01 52.40



LOWER UPPER

% Lymphocytes

CD7+ 130 81.01 65.80 92.79

CD56+ 129 14.39 4.03 32.92

% Granulocytes

CD11b+ 130 99.66 97.58 100.00

CD13+ 129 99.41 92.36 100.00

CD15+ 130 99.68 97.55 99.99

CD16+ 130 95.48 84.59 99.68

% Monocytes

CD14+ 129 96.94 90.18 99.46

CD33+ 129 97.90 90.73 99.70

HLA-DR+ 130 98.40 88.69 99.95

P R EC I S ION :




MEAN

% Lymphocytes

CD19+ (BL1 Tube) 2.80% 14.20

CD19+ (BL2 Tube) 2.74% 14.34

CD20+ 3.56% 14.78

CD5+ 1.04% 71.86


CD19+Kappa+ 2.91% 57.42

CD19+Lambda+ 4.06% 40.23

% CD38 Monocytes

CD38+ 0.89% 94.45


CD10+ 0.03% 99.96



MEAN

% Lymphocytes

CD2+ 0.67% 81.78

CD5+ 0.93% 72.73

CD7+ 0.73% 74.65

CD56+ 3.32% 13.76

CD3+ 0.76% 71.16

CD3+CD4+ 1.24% 45.48

CD3+CD8+ 1.94% 22.67

SOL A S T R A M Y ELOMONOC Y T IC L IN E AG E K I T


MEAN

% Lymphocytes

CD7+ 1.59% 73.88

CD56+ 7.34% 14.16

% Granulocytes

CD11b+ 2.34% 97.26

CD13+ 0.43% 99.91

CD15+ 0.20% 99.76

CD16+ 0.56% 94.56

% Monocytes

CD14+ 0.91% 89.35

CD33+ 0.94% 95.44

HLA-DR+ 0.56% 95.20


CD34+ (ML2 Tube) 9.26% 11.85

CD34+ (ML3 Tube) 7.00% 11.75


CD117+ 9.23% 13.89


REPRESENTAT IV E RESULTS :





REPRESENTAT IVE RESULTS :







LOWER UPPER

% Lymphocytes

CD2+ 130 85.24 72.63 95.35

CD5+ 130 78.65 61.42 88.13

CD7+ 130 81.53 69.74 91.04

CD56+ 130 14.38 3.97 32.34

CD3+ 130 77.82 62.42 88.43

CD3+CD4+ 130 49.52 17.61 70.19

CD3+CD8+ 130 26.68 12.01 52.40



LOWER UPPER

% Lymphocytes

CD7+ 130 81.01 65.80 92.79

CD56+ 129 14.39 4.03 32.92

% Granulocytes

CD11b+ 130 99.66 97.58 100.00

CD13+ 129 99.41 92.36 100.00

CD15+ 130 99.68 97.55 99.99

CD16+ 130 95.48 84.59 99.68

% Monocytes

CD14+ 129 96.94 90.18 99.46

CD33+ 129 97.90 90.73 99.70

HLA-DR+ 130 98.40 88.69 99.95

P R EC I S ION :




MEAN

% Lymphocytes

CD19+ (BL1 Tube) 2.80% 14.20

CD19+ (BL2 Tube) 2.74% 14.34

CD20+ 3.56% 14.78

CD5+ 1.04% 71.86


CD19+Kappa+ 2.91% 57.42

CD19+Lambda+ 4.06% 40.23

% CD38 Monocytes

CD38+ 0.89% 94.45


CD10+ 0.03% 99.96



MEAN

% Lymphocytes

CD2+ 0.67% 81.78

CD5+ 0.93% 72.73

CD7+ 0.73% 74.65

CD56+ 3.32% 13.76

CD3+ 0.76% 71.16

CD3+CD4+ 1.24% 45.48

CD3+CD8+ 1.94% 22.67

SOL A S T R A M Y ELOMONOC Y T IC L IN E AG E K I T


MEAN

% Lymphocytes

CD7+ 1.59% 73.88

CD56+ 7.34% 14.16

% Granulocytes

CD11b+ 2.34% 97.26

CD13+ 0.43% 99.91

CD15+ 0.20% 99.76

CD16+ 0.56% 94.56

% Monocytes

CD14+ 0.91% 89.35

CD33+ 0.94% 95.44

HLA-DR+ 0.56% 95.20


CD34+ (ML2 Tube) 9.26% 11.85

CD34+ (ML3 Tube) 7.00% 11.75


CD117+ 9.23% 13.89




LOWER UPPER

% Lymphocytes

CD2+ 130 85.24 72.63 95.35

CD5+ 130 78.65 61.42 88.13

CD7+ 130 81.53 69.74 91.04

CD56+ 130 14.38 3.97 32.34

CD3+ 130 77.82 62.42 88.43

CD3+CD4+ 130 49.52 17.61 70.19

CD3+CD8+ 130 26.68 12.01 52.40



LOWER UPPER

% Lymphocytes

CD7+ 130 81.01 65.80 92.79

CD56+ 129 14.39 4.03 32.92

% Granulocytes

CD11b+ 130 99.66 97.58 100.00

CD13+ 129 99.41 92.36 100.00

CD15+ 130 99.68 97.55 99.99

CD16+ 130 95.48 84.59 99.68

% Monocytes

CD14+ 129 96.94 90.18 99.46

CD33+ 129 97.90 90.73 99.70

HLA-DR+ 130 98.40 88.69 99.95

P R EC I S ION :




MEAN

% Lymphocytes

CD19+ (BL1 Tube) 2.80% 14.20

CD19+ (BL2 Tube) 2.74% 14.34

CD20+ 3.56% 14.78

CD5+ 1.04% 71.86


CD19+Kappa+ 2.91% 57.42

CD19+Lambda+ 4.06% 40.23

% CD38 Monocytes

CD38+ 0.89% 94.45


CD10+ 0.03% 99.96



MEAN

% Lymphocytes

CD2+ 0.67% 81.78

CD5+ 0.93% 72.73

CD7+ 0.73% 74.65

CD56+ 3.32% 13.76

CD3+ 0.76% 71.16

CD3+CD4+ 1.24% 45.48

CD3+CD8+ 1.94% 22.67

SOL A S T R A M Y ELOMONOCY T IC L IN E AG E K I T


MEAN

% Lymphocytes

CD7+ 1.59% 73.88

CD56+ 7.34% 14.16

% Granulocytes

CD11b+ 2.34% 97.26

CD13+ 0.43% 99.91

CD15+ 0.20% 99.76

CD16+ 0.56% 94.56

% Monocytes

CD14+ 0.91% 89.35

CD33+ 0.94% 95.44

HLA-DR+ 0.56% 95.20


CD34+ (ML2 Tube) 9.26% 11.85

CD34+ (ML3 Tube) 7.00% 11.75


CD117+ 9.23% 13.89


R E AG EN T S AVA I L A B I L I T Y ( C E- I V D ) :

• Solastra B Lineage Kit: PN A66286 º• Solastra T Lineage Kit: PN A66287 º• Solastra Myelomonocytic Lineage Kit: PN A66288 º• Solastra Negative Control Tube: PN A66256 ¤ º• Solastra QuickCOMP 5 Kit: PN A83571¤

T ER M DEF IN I T ION S :

• ACD Acid Citrate Dextrose• CLSI Clinical and Laboratory

Standards Institute• ECD Energy Coupled Dye (PE-Texas Red®-x)• EDTA Ethylenediaminetetraacetic acid• FC 500 Beckman Coulter Cytomics FC 500 Flow

Cytometer series• FITC Fluorescein isothiocyanate• HIFCS Heat-Inactivated Fetal Calf Serum• HIMS Heat-Inactivated Mouse Serum• N/A Not Applicable• PC5.5 PE-Cyanine 5.5• PC7 PE-Cyanine 7• PE R-Phycoerythrin• SS Side scatter

B IBL IOG R A P H Y

1. Wood BL, Arroz M, Barnett D, DiGiuseppe J, Greig B, Kussick SJ, Oldaker T, Shenkin M, Stone E and Wal-lace P, “2006 Bethesda International Consensus Re-commendations on the Immunophenotypic Analysis of

Hematolymphoid Neoplasia by Flow Cytometry: Optimal reagents and reporting for the flow cytometric diagnosis of hematopoietic neoplasia.” Cytometry Part B (Clinical Cytometry), 72B:S14-22 (2007).

2. Davis BH, Holden JT, Béné MC, Borowitz MJ, Braylan RC, Cornfield D, Gorczyca W, Lee R, Maiese R, Orfao A, Wells D, Wood BL and Stetler-Stevenson M, “2006 Bethesda International Consensus Recommendations on the Flow Cytometric Immunophenotypic Analysis of Hematolymphoid Neoplasia: Medical Indications.” Cytometry Part B (Clinical Cytometry) 72B:S5–S13 (2007).

3. Swerdlow SH, Campo E, Harris NL, Jaffe ES, Pileri SA, Stein H, Thiele J and Vardiman JW (Eds.): WHO Clas-sification of Tumours of Hæmatopoietic and Lymphoid Tissues, 4th Edition, IARC Press, Lyon (2008).

4. Tholen DW, “Protocols for Determination of Limits of Detection and Limits of Quantitation”, CLSI EP17A Approved Guideline, First Edition (2004).

‡ : CE-marking as per the requirements of the European In Vitro Diagnostics Directive (98/79/EC), following declaration of conformity to the European Regulatory Bodies

º : Not available in the U.S., pending submission and clea-rance by the U.S. FDA.

¤ : Product in development.

Beckman Coulter and the stylized logo are registered tra-demarks of Beckman Coulter, Inc. Flow-Check, Flow-Set, IMMUNO-TROL, IOTest, Solastra, Stem-Trol and VersaLyse are trademarks of Beckman Coulter, Inc. Texas-Red is a trademark of Molecular Probes, Inc.

Australia, Gladesville (61) 2 9844 6000 Canada, Mississauga (1) 905 819 1234 China, Beijing (86) 10 6515 6028 Czech Republic, Prague (420) 272 01 73 32 Eastern Europe, Middle East, North Africa, South West Asia: Switzerland, Nyon (41) 22 365 3707 France, Villepinte (33) 1 49 90 90 00 Germany, Krefeld (49) 2151 33 35 Hong Kong (852) 2814 7431 India, Mumbai (91) 22 3080 5000 Italy, Cassina de’ Pecchi, Milan (39) 02 953921 Japan, Tokyo (81) 3 5530 8500 Korea, Seoul (82) 2 404 2146 Latin America (1) (305) 380 4709 Mexico, Mexico City (001) 52 55 9183 2800 Netherlands, Woerden (31) 348 462462 Puerto Rico (787) 747 3335 Singapore (65) 6339 3633 South Africa/Sub-Saharan Africa, Johannesburg (27) 11 564 3203 Spain, Madrid (34) 91 3836080 Sweden, Bromma (46) 8 564 85 900 Switzerland, Nyon (41) 0800 850 810 Taiwan, Taipei (886) 2 2378 3456 Turkey, Istanbul (90) 216 570 17 17

UK, High Wycombe (44) 01494 441181 USA, Brea, CA (1) 800 352 3433, (1) 714 993 5321

B2010-05-25/Solastra www.beckmancoulter.com © 2010 Beckman Coulter, Inc. PRINTED IN U.S.A.


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R E AG EN T S AVA I L A B I L I T Y ( C E- I V D ) ‡

• SolastraBLineageKit:PNA66286∆,25tests - Solastra B Lineage Vial BL1: Kappa-FITC / Lambda-PE / CD19-ECD / CD5-PC5.5 / CD45-PC7 - Solastra B Lineage Vial BL2: CD20-FITC / CD10-PE / CD19-ECD / CD38-PC5.5 / CD45-PC7

• SolastraTLineageKit:PNA66287∆,25tests - Solastra T Lineage Vial TL1: CD2-FITC / CD56-PE / CD7-ECD / CD5-PC5.5 / CD45-PC7 - Solastra T Lineage Vial TL2: CD8-FITC / CD4-PE / – / CD3-PC5.5 / CD45-PC7

• SolastraMyelomonocyticLineageKit:PNA66288∆,25tests - Solastra M. Lineage Vial ML1: CD15-FITC / CD11b-PE / CD16-ECD / CD14-PC5.5 / CD45-PC7 - Solastra M. Lineage Vial ML2: HLADR-FITC / CD56-PE / CD34-ECD / CD117-PC5.5 / CD45-PC7 - Solastra M. Lineage Vial ML3: CD7-FITC / CD13-PE / CD34-ECD / CD33-PC5.5 / CD45-PC7

• SolastraQuickCOMP5Kit:PNA83571∆¤,25tests - Solastra QuickCOMP 5 – Vial 1: CD45-FITC - Solastra QuickCOMP 5 – Vial 2: CD45-PE - Solastra QuickCOMP 5 – Vial 3: CD45-ECD - Solastra QuickCOMP 5 – Vial 4: CD45-PC5.5 - Solastra QuickCOMP 5 – Vial 5: CD45-PC7

Beckman Coulter and the stylized logo are registered trademarks of Beckman Coulter, Inc. Flow-Check, Flow-Set, IMMUNO-TROL, IOTest, Solastra, Stem-Trol and VersaLyse are trademarks of Beckman Coulter, Inc. Texas-Red is a trademark of Molecular Probes, Inc.

B IBL IOG R A P H Y

1. Wood BL, Arroz M, Barnett D, DiGiuseppe J, Greig B, Kussick SJ, Oldaker T, Shenkin M, Stone E and Wallace P, “2006 Bethesda International Consensus Recommenda-tions on the Immunophenotypic Analysis of Hematolymp-hoid Neoplasia by Flow Cytometry: Optimal reagents and reporting for the flow cytometric diagnosis of hematopoietic neoplasia.” Cytometry Part B (Clinical Cytometry), 72B:S14-22 (2007).

2. Davis BH, Holden JT, Béné MC, Borowitz MJ, Braylan RC, Cornfield D, Gorczyca W, Lee R, Maiese R, Orfao A, Wells D, Wood BL and Stetler-Stevenson M, “2006 Bethesda International Consensus Recommendations on the Flow Cytometric Immunophenotypic Analysis of Hematolymp-hoid Neoplasia: Medical Indications.” Cytometry Part B (Clinical Cytometry) 72B:S5–S13 (2007).

3. Swerdlow SH, Campo E, Harris NL, Jaffe ES, Pileri SA, Stein H, Thiele J and Vardiman JW (Eds.): WHO Classifica-tion of Tumours of Hæmatopoietic and Lymphoid Tissues, 4th Edition, IARC Press, Lyon (2008).

4. Tholen DW, “Protocols for Determination of Limits of De-tection and Limits of Quantitation”, CLSI EP17A Approved Guideline, First Edition (2004).

‡ : CE-marking as per the requirements of the European In Vitro Diagnostics Directive (98/79/EC), following declara-tion of conformity to the European Regulatory Bodies

∆: Not available in the U.S., pending submission and clea-rance by the U.S. FDA.

¤ : Product in development.

For information about Beckman Coulter products for flow cytometry and immunophenotyping, please consult: www.coulterflow.com

Australia, Gladesville (61) 2 9844 6000 Austria, Vienna (43) 662 857220 72 Canada, Mississauga (1) 905 819 1234 China, Shanghai (86) 21 3865 1000 Croatia, Zagreb (38) 51 489 9003 Czech Republic, Prague (420) 272 017 999 Eastern Europe, Middle East, North Africa, South West Asia: Switzerland, Nyon (41) 22 365 3707 France, Villepinte (33) 1 49 90 90 00 Germany, Krefeld (49) 2151 33 35 Hong Kong (852) 2814 7431 Hungary, Budapest (361) 25 09 330 India, Mumbai (91) 22 3080 5000 Italy, Cassina de’ Pecchi, Milan (39) 02 953921 Japan, Tokyo (81) 3 5530 8500 Korea, Seoul (82) 2 404 2146 Latin America (1) (305) 380 4709 Malaysia, Kuala Lumpur (60) 3 5621 4793 Mexico, Mexico City (001) 52 55 9183 2800 Netherlands, Woerden (31) 348 462462 Poland, Warszawa (48) 22 366 0180 Puerto Rico (787) 747 3335 Russia, Moscow (7) 495 9846730 Singapore (65) 6339 3633 South Africa/Sub-Saharan Africa, Johannesburg (27) 11 564 3203 Spain, Madrid (34) 91 3836080 Sweden, Bromma (46) 8 564 85 900 Switzerland, Nyon (41) 0800 850 810 Taiwan, Taipei (886) 2 2730 2500 Turkey, Istanbul (90) 216 570 17 17 UK, High Wycombe (44) 01494 441181 USA, Brea, CA (1) 800 352 3433, (1) 714 993 5321

BR-14088A www.beckmancoulter.com © 2010 Beckman Coulter, Inc.

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