TEST DIRECTORY

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Laboratory：Akiruno

○AmoyDx lung cancer multi-panel 7-gene IVD (12-24 months)

CODE：00Q17 6

  • TEST NAME SPECIMEN
    REQUIREMENT
    （ｍL）     CONTAINER CAP COLOR STORE
    TEMPERATURE
    (STABILITY)     TURNAROUND
    TIME (DAY)     METHODOLOGY REFERENCE RANGE
    (UNIT)
  • AmoyDx lung cancer multi-panel 7-gene IVD (12-24 months)
    Unstained specimen slide
    7 to 10 sheets
    thickness 5μm
    Z10 Room temperature
     4-7 PCR (real-time PCR), RT-PCR (real-time PCR)

COMMENT


The purpose of this test is to analyze BRAFV600E mutations, EGFR gene mutations, ALK fusion genes, ROS1 fusion genes, MET gene exon 14 skipping mutations, KRASG12C gene mutations, and RET fusion genes in genomic DNA and RNA extracted from cancer tissue, and to determine whether or not drugs listed in the separate table are suitable for non-small cell lung cancer patients.
The required percentage of tumor cells for the test is 20% or more (recommended 30% or more). Please see below for points to note when submitting unstained specimen slides.
Please avoid making duplicate requests with other items. This test method is more susceptible to contamination, so please handle specimens with care.
When requesting this test, be sure to also request the nucleic acid extraction item (item code No.: M9514).
*When submitting unstained specimen slides
-Immediately immerse the collected tissue in 10% neutral buffer formalin solution and fix it (fixation time is 6 to 4 (We recommend leaving the slide for approximately 8 hours.) When submitting the slide, please prepare serial sections at a thickness of 5 μm from the formalin-fixed paraffin-embedded tissue block.
-Unstained slides must be histopathologically evaluated and confirmed that they contain the required percentage of tumor cells for the test (the percentage of tumor cells among all cells in the specimen). If the required percentage is not met, please mark the tumor cell area from the back of the unstained slide. If the slide is submitted without marking, macrodissection will not be possible, resulting in false negative results. Please note that this may affect the quality of the results.
- Please submit FFPE tissue prepared within the last 12 to 24 months.
- Since nucleic acids in unstained specimen slides are fragmented due to formalin fixation of the tissue, analysis may be impossible depending on the type and composition of the fixative, fixation time, and storage conditions of the specimen after fixation. Please note that biopsy materials in particular often contain very small amounts of specimens, and there may be cases where the tissue fragments on the paraffin sections are very small or may not contain tumor cells.

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