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HelpTest Code CALRC Calreticulin ex9mut Immunostain, Technical Component Only
Reporting Name
Calreticulin ex9mut IHC, Tech OnlyUseful For
Identifying the presence of CALR exon 9 frameshift alterations in myeloproliferative neoplasms
Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| IHTOI | IHC Initial, Tech Only | No | No |
| IHTOA | IHC Additional, Tech Only | No | No |
Testing Algorithm
For the initial technical component only immunohistochemical (IHC) stain performed, the appropriate bill-only test ID will be reflexed and charged (IHTOI). For each additional technical component only IHC stain performed, an additional bill-only test ID will be reflexed and charged (IHTOA).
Method Name
Immunohistochemistry (IHC)
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
TECHONLYOrdering Guidance
This test includes only technical performance of the stain (no pathologist interpretation is performed). If diagnostic consultation by a pathologist is required order PATHC / Pathology Consultation.
Shipping Instructions
Attach the green pathology address label and the pink Immunostain Technical Only label included in the kit to the outside of the transport container.
Specimen Required
Supplies: Immunostain Technical Only Envelope (T693)
Specimen Type: Tissue
Container/Tube: Immunostain Technical Only Envelope
Preferred: 2 Unstained positively charged glass slide (25- x 75- x 1-mm) per test ordered; sections 4-microns thick
Acceptable: Formalin-fixed, paraffin-embedded (FFPE) tissue block
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| TECHONLY | Ambient (preferred) | ||
| Refrigerated | |||
Reject Due To
| Wet/frozen tissue Cytology smears Nonformalin fixed tissue Nonparaffin embedded tissue Noncharged slides ProbeOn slides |
Reject |
Day(s) Performed
Monday through Friday
CPT Code Information
88342-TC, primary
88341-TC, if additional IHC
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| CALRC | Calreticulin ex9mut IHC, Tech Only | Order only;no result |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 71493 | Calreticulin ex9mut IHC, Tech Only | Bill only; no result |
Secondary ID
71486Clinical Information
The detection of calreticulin exon 9 frameshift alterations can assist in the diagnosis and prognostication of myeloproliferative diseases. Although these alterations are heterogeneous, they all result in a protein with a novel 36-amino acid C terminus the anticalreticulin CAL2 clone specifically identifies.
Most patients with essential thrombocythemia or primary myelofibrosis not associated with Janus kinase 2 (JAK2) or MPL variants are associated with CALR exon 9 variants and primary myelofibrosis patients carrying CALR variants have a more indolent clinical course.
Interpretation
This test does not include pathologist interpretation, only technical performance of the stain. If interpretation is required, order PATHC / Pathology Consultation for a full diagnostic evaluation or second opinion of the case.
The positive and negative controls are verified as showing appropriate immunoreactivity. If a control tissue is not included on the slide, a scanned image of the relevant quality control tissue is available upon request; call 855-516-8404.
Interpretation of this test should be performed in the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
Cautions
Age of a cut paraffin section can affect immunoreactivity. Stability thresholds vary widely among published literature and are antigen-dependent. Best practice is for paraffin sections to be cut within 6 weeks.
Clinical Reference
1. Vannucchi AM, Rotunno G, Bartalucci N, et al. Calreticulin mutation-specific immunostaining in myeloproliferative neoplasms: pathogenetic insight and diagnostic value. Leukemia. 2014;28(9):1811-1818. doi:10.1038/leu.2014.100
2. Stein H, Bob R, Durkop H, et al. A new monoclonal antibody (CAL2) detects CALRETICULIN mutations in formalin-fixed and paraffin-embedded bone marrow biopsies. Leukemia. 2016;30(1):131-135. doi:10.1038/leu.2015.192
3. Klampfl T, Gisslinger H, Harutyunyan AS, et al. Somatic mutations of Calreticulin in myeloproliferative neoplasms. N Engl J Med. 2013;369(25):2379-2390. doi:10.1056/NEJMoa1311347
4. Magaki S, Hojat SA, Wei B, So A, Yong WH. An introduction to the performance of immunohistochemistry. Methods Mol Biol. 2019;1897:289-298. doi:10.1007/978-1-4939-8935-5_25
Method Description
Immunohistochemistry on sections of paraffin-embedded tissue.(Unpublished Mayo method)
Report Available
1 to 3 daysSpecimen Retention Time
Until staining is complete.Test Classification
This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.Forms
If not ordering electronically, complete, print, and send a Immunohistochemical (IHC)/In Situ Hybridization (ISH) Stains Request (T763) with the specimen.