TEST DIRECTORY

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Laboratory：Akiruno

○AmoyDx lung cancer multi-panel 7-gene IVD (3 months or less)

CODE：00P87 0

  • 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 (3 months or less)
    Unstained specimen slide
    7 to 10 sheets
    thickness 5μm
    Z10 Room temperature
     4-7 PCR (real-time PCR), RT-PCR (real-time PCR)

COMMENT


Genomic DNA and RNA extracted from cancer tissues are analyzed for BRAFV600E mutations, EGFR gene mutations, ALK fusion gene, ROS1 fusion gene, MET gene exon 14 skipping mutations, KRAS RET fusion genes to determine the indications for the drugs listed separately for patients with non-small cell lung cancer.
The percentage of tumor cells required for testing is 20% or more (recommended 30% or more). See notes on submitting unstained specimen slides below.

Avoid duplicate requests in one sample. Since contamination has a greater effect on this test method, handle specimens with care when collecting them.
When requesting this test, ensure to also request the nucleic acid extraction item (item code: M9514)
●About submission of unstained specimen slides
- The collected tissues should be immediately immersed in 10% neutral buffered formalin solution and fixed (fixation time of 6~48 hours is recommended). For submission, make serial sections of 5 μm thickness from formalin-fixed paraffin-embedded tissue blocks.
- Unstained specimen slides should be histopathologically evaluated and confirmed to contain at least the required percentage of tumor cells (tumor cells as a percentage of total cells in the specimen) for the examination. If the required percentage is not met, mark the tumor cell area from the reverse side of the unstained specimen slide; otherwise, macrodissection will not be possible, which may result in false negative or other negative results.
Submit FFPE tissue prepared within the past 3 months.
- Since nucleic acids in unstained specimen slides are fragmented by formalin fixation of the tissue, analysis may not be possible depending on the type and composition of the fixation solution, fixation time, and storage conditions of the specimen after fixation. Note that biopsy specimens, in particular, are often minute in volume and may contain only a small amount of tissue on paraffin sections or may not contain tumor cells.

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