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HelpOrder 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
This assay requires at least 50 tumor cells.
Specimen Type: Tissue
Supplies: Pathology Packaging Kit (T554)
Submit:
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.
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, ManualSpecimen Type
SpecialSpecimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Special | Ambient (preferred) | |
| Refrigerated | ||
Reject Due To
| Decalcified paraffin embedded tissue | Reject |
| Wet/frozen tissue | Reject |
| Cytology smears | Reject |
| Nonformalin fixed tissue including alcohol-formalin-acetic acid (AFA), 95% ethanol, PREFER fixatives or Zinc formalin | Reject |
| Nonparaffin embedded tissue | Reject |
| Noncharged slides | Reject |
| ProbeOn slides | Reject |
Reference Values
An interpretive report will be provided.
Method Description
Immunoperoxidase staining and detection of Claudin 18 (CLDN18) is performed in formalin-fixed, paraffin-embedded tissue sections using the VENTANA CLDN18 (43-14A) RxDx Assay. The 4-micron tissue sections are deparaffinized, subjected to heat-induced antigen retrieval and peroxidase inhibitor, incubated with a monoclonal antibody (clone 43-14A), and visualized using a proprietary kit detection system. Sections are counterstained with hematoxylin. Stained slides are examined microscopically by the consulting anatomic pathologist.(Package insert: VENTANA CLDN18 (43-14A) RxDx Assay. Ventana Medical Systems, Inc.; 1016387US Rev A, 10/11/2024)
Results are interpreted using the manufacturer-provided interpretation guide. A minimum of 50 tumor cells are required for interpretation of results.(Instruction manual: VENTANA CLDN18 (43-14A) RxDx Assay Interpretation Guide for Gastric Adenocarcinoma including Gastroesophageal Junction (GEJ). Ventana Medical Systems, Inc.; 1021576EN Rev B, 10/01/2024)
Day(s) Performed
Monday through Friday
Performing Laboratory
Mayo Clinic Laboratories in Rochester
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.