Back to MPLN Home Client Services: +1 865.380.9746

CD19, technical only

Test ID: I CD19 TC CPT Code: 88342 TC

Expected Turnaround Time
2 days
Stated turn-around-times (TATs) are for clinical use only and subject to change based on biopharma protocol requirements. Final TATs will be specified in the biopharma study contract.

Clinical Information
CD19 is a member of the immunoglobulin superfamily expressed on the surface of B lymphocytes and follicular dendritic cells. CD19 is a critical regulator in B-cell development, activation, and differentiation, expressed from the earliest recognizable B-cell lineage stage throughout development, and then lost upon plasma cell maturation. Technical component only. Pathologist read not included.


Specimen Requirements


Specimen Requirements
  • Fresh Tissues: Fixative should be at a 20:1 fixative to tissue ratio, 10% neutral buffered formalin (NBF) for 6-72 hours (48-72 hours PREFERRED)
  • Formalin-fixed Paraffin Embedded Tissue (FFPE blocks): FFPE Block, Formalin Fixed
  • Unstained slides: 2 slides (3-5 μM) per stain (min 1 slide per stain), Formalin Fixed

Specimen Stability
  • Fresh Tissue Tissues: ≤ 72 Hours
  • Formalin-fixed Paraffin Embedded Tissue (FFPE blocks): Indefinite
  • Unstained slides: Indefinite
  • Stained slides: Indefinite

Storage Requirements

15°C to 25°C


Shipping Conditions
Ambient

Shipping Recommendations
  • Fresh Tissues: AMBIENT
  • Formalin-fixed Paraffin Embedded Tissue (FFPE blocks) and unstained slides: AMBIENT, Use a refrigerated (NOT FROZEN) gel pack in the shipment to protect from extreme temperatures. Separate gel pack from specimen.
  • Specimens may be transferred to 70% alcohol for transportation purposes after fixation in 10% NBF or B plus.

Specimen Rejection Criteria

Specimens must be fixed in 10% NBF or B plus. All other fixatives will be rejected. 


Test Details


Synonyms

B-Lymphocyte Surface Antigen B4, T-Cell Surface Antigen Leu-12


Test Method
Immunohistochemistry

Methodology Category
IHC

Regulatory Status
IVD, CE-marked

Special Considerations
  • Fresh Tissues: Specimens may be fixed in formalin for 24-72 hours by collection sites, then transferred to 70% ethanol and stored at 2-8°C for longer term storage if needed. Samples must be tested 3 months after placing in ethanol.
  • Unstained slides: Positively charged glass slides required to prevent background staining and prevent tissue loss. Slides should be left unbaked.