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CK 8/18, technical only

Test ID: I CK8/18 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
Cytokeratins (CK) 8 and18 are major components of the intermediate filaments in thyroid, liver and most simple epithelia. CK8/18 can be used as a marker to aid in the identification of adenocarcinomas and squamous cell carcinomas, Paget cells, metastatic gastric and colorectal carcinomas. 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

Keratin 8, KRT8, Cytokeratin-8, CK 8, CK-8, K8, K-8, K 8, Keratin Type II Cytoskeletal 8, Type-II keratin Kb8, K2C8, KO, Keratin 18, Cell Proliferation-Inducing Gene 46 Protein, Keratin Type I Cytoskeletal 18, KRT18, Cytokeratin-18, CK-18, CK 18, K18, CYK18, Keratin 18 Type I


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.