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Test Code CLD18 Claudin 18 (CLDN18) (43-14A), Semi-Quantitative Immunohistochemistry, Manual


Shipping Instructions


Attach the green "Attention Pathology" address label (T498) to the outside of the transport container before putting into the courier mailer.



Necessary Information


A pathology/diagnostic report and a brief history are required.



Specimen Required


Specimen Type: Tissue

Supplies: Pathology Packaging Kit (T554)

Collection Instructions: Formalin-fixed, paraffin-embedded tissue block; or 3 unstained glass, "positively charged" slides with 4-microns formalin-fixed, paraffin-embedded tissue

Additional Information: One slide will be stained with hematoxylin and eosin and returned.


Secondary ID

620665

Useful For

Identification of tumor cells expressing claudin 18

 

As an aid in screening patients who may be eligible for VYLOY (zolbetuximab) treatment

Method Name

Immunohistochemistry (IHC)

Reporting Name

CLDN18, SemiQuant IHC, Manual

Specimen Type

Special

Specimen Stability Information

Specimen Type Temperature Time Special Container
Special Ambient (preferred)
  Refrigerated 

Reject Due To

Decalcified paraffin embedded tissue
Wet/frozen tissue
Cytology smears
Nonformalin fixed tissue including alcohol-formalin-acetic acid (AFA), 95% ethanol, PREFER fixatives or Zinc formalin
Nonparaffin embedded tissue
Noncharged slides
ProbeOn slides		 Reject

Reference Values

An interpretive report will be provided.

Day(s) Performed

Monday through Friday

Report Available

5 to 7 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

88360

LOINC Code Information

Test ID Test Order Name Order LOINC Value
CLD18 CLDN18, SemiQuant IHC, Manual 105011-1

 

Result ID Test Result Name Result LOINC Value
620666 Interpretation 50595-8
621004 Participated in the Interpretation No LOINC Needed
621005 Report electronically signed by 19139-5
621006 Material Received 81178-6
621007 Disclaimer 62364-5
621008 Case Number 80398-1

Forms

If not ordering electronically, complete, print, and send a Immunohistochemical (IHC)/In Situ Hybridization (ISH) Stains Request (T763) with the specimen.