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Test Code 5422616 ERBB2 MUTATION ANALYSIS

Test ID

1236000020

Specimen Requirements

Collection Requirements Specimen Type: Formalin fixed paraffin tissue on slides, FNA, Solid
Tissue
Specimen handling:
Corresponding pathologist’s report
must accompany FFPE specimen.
Formalin-fixed parafin-embedded (FFPE) unstained slides: 10
unstained sections, each 10-microns thick, total >100 mcg tumor;
corresponding H&E stained 5-micron section REQUIRED; no
mercury-based (B-5) fixation; FNA cell blocks should have >50%
tumor cells.
FNA specimens: unrefrigerated fresh neat or in saline or RPMI. Fresh specimens must be received in lab within 3 hours of collection.
Refrigerated (not frozen) samples must be received in lab within 24 hours of collection. At least 100,000 tumor cells are required.
Tumor cells must be >50% of specimen as predetermined by referring
cytopathologist.
Solid Tissue, fresh or frozen: >500 mcg tumor. Tumor must constitute
>50% of specimen as predetermined by referring pathologist. Collect
in RPMI, saline, or neat. Fresh specimens must be received in lab
within 3 hours of collection. Frozen specimens must be received in
lab within 72 hours of collection, ship on dry ice.
Rejection Criteria: Mercury-based fixative (B-5) FFPE specimens.
Unstained FFPE sections without corresponding H&E section. Fresh FNA or solid tissue received in water. Heparinized specimens. Frozen FNA cells.
Contact Info Lab: (214)-648-0960 Customer Service: 214-645-7057
For after hours, weekends and holidays, please contact the person on
call at 214 786 3127.
Shipping / Handling Instructions Corresponding pathologist’s report must accompany specimen. Formalin-fixed paraffin-embedded (FFPE) unstained slides: 10 unstained sections, each 10-microns thick, corresponding H&E stained 5-micron section required; no mercury based (B-5) fixation

Container Type

Laboratory Container Default Temperature Minimum Volume
BIOCENTER LAB STERILE CONTAINER
BIOCENTER LAB AP SLIDES Yes

Performing Section

BIOCENTER LAB: MOLECULAR DIAGNOSTICS

Components

Component Name Component ID LOINC Code
MOLDX_GENERIC_TEXT_FINAL_RESULT 1230002393
ERBB2 MUTATION INTERPRETATION 1230002633
ERBB2 MUTATION DISCLAIMER 12300002410
MOLDX ERBB2 MUTATION SIGNATURE 12300002466