TEST DIRECTORY

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Laboratory:Akiruno

BRAFV600E gene analysis [rSSO]

  • TEST NAME SPECIMEN
    REQUIREMENT
    (mL)
    CONTAINER CAP COLOR STORE
    TEMPERATURE
    (STABILITY)
    TURNAROUND
    TIME (DAY)
    METHODOLOGY REFERENCE RANGE
    (UNIT)
  • Specified days
    BRAFV600E gene analysis [rSSO]
    Unstained specimen slide
    5 sheets
    thickness 5 to 10μm
    Z10 Room temperature
    5-10 PCR-rSSO method

COMMENT


Acceptable days are Monday~Friday.
The purpose is to assist in the determination of indications for dabrafenib mesylate and trametinib dimethyl sulfoxide adduct in patients with solid tumors (excluding colorectal cancer, lung cancer, and malignant melanoma) and hairy cell leukemia.
Pathology material is being analyzed for the BRAF gene V600E mutation. Only pathology material can be requested.
The percentage of tumor cells required for the test is 10% or more; specimens with less than 10% may have a false negative or withhold a determination.
See below for notes on submitting unstained specimen slides.
Avoid duplicate requests in one items.
●Submission Conditions
Unstained specimen slides should be histopathologically evaluated to ensure that the required percentage of tumor cells (tumor cells as a percentage of total cells in the specimen) is present. If the required percentage is not met, mark the tumor cell area from the back of the unstained specimen slide. Note that submission of unstained specimen slides without marking may result in failure of macrodissection, which may affect the results, such as a false negative result.
●About unstained specimen slides
Immediately immerse the collected tissue in a 10% neutral buffered formalin solution and fix it (recommended fixation time is 6 to 48 hours). When submitting, please prepare serial sections at the specified thickness from formalin-fixed paraffin-embedded (FFPE) blocks prepared within the last 3 years, if possible. Please be careful to avoid contamination by changing the microtome blade for each specimen when slicing. Please note that as nucleic acids are fragmented due to formalin fixation of tissues, analysis may not be possible depending on the type and composition of the fixative, fixation time, and storage condition of the specimen after fixation.
●About biopsy specimens
Biopsy specimens often contain only a small amount of specimen, and there is a possibility that most of the tissue itself has disappeared or that the tissue has become a piece of tissue that does not contain tumor cells. Beaware of this in advance.

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