CD3+ Cell Count for Cellular Therapy Products

Test Name

CD3+ Cell Count for Cellular Therapy Products

Alternate Description

CD3+ Cell Count for Blood and Apheresis products used for Cellular Therapy Products by Flow Cytometry

LIS Code

Not Applicable

Availability

09:00 - 17:00 hours; Monday through Friday, other times may be available call X7298

Lab Section

Hematopoietic Cell Therapy Laboratory

Fluid Type And Minimum Volume

Apheresis sample, minimum volume 0.5 mL

Test Includes

CD3+ cells per uL

Specimen Tube Type Transport

Non-gel lavender top tube

Container Whole Blood Required

3 mL in a EDTA Non-Gel lavender Top tube

Summary Test Name

CD3+ Cell Count for Cellular Therapy Products

Specimen Stability

24 hours refrigerated

Specimen Preparation In House

Call Hematopoietic Cell Therapy Laboratory. Do not process.

Test Turnaround Time Routines And Stats

Stat 2 hours

Reference Value

Peripheral blood: > 614 CD3+ cells per µL, Apheresis dependent on donor health, method, and length of apheresis collection procedure

Additional Test Information

This test was developed and its performance characteristics determined by the Hematopoietic Cell Therapy Laboratory. It has not been cleared or approved by the US Food and Drug Administration. FDA does not require this test to go through premarket FDA review. This test is used for clinical purposes and should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical testing.

This test provides a viable CD3+ cell count per µL utilizing fluorescent antibodies targeted to CD45+ and CD3+ cells and a flow cytometer to quantify cells. The results are intended to determine if a cell collection is indicated from peripheral blood or to quantify the number of cells collected.

Additional details of the test procedure may be obtained by calling the laboratory at (717) 531-7298.