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Test Code AFIRMA AFIRMA GENOMIC SEQUENCING CLASSIFIER FOR INDETERMINATE THYROID NODULES

Important Note

This test is utilized in the management of patients with cytologically indeterminate thyroid nodules.

This test will be automatically ordered on thyroid nodules with indeterminate cytological results. Indeterminate results (Bethesda Category III-IV), includes Follicular Lesion of Undetermined Significance, Atypia of Undetermined Significance, Suspicious for Follicular Neoplasm/Follicular Neoplasm and Suspicious for Hurthle Cell Neoplasm/Hurthle Cell Neoplasm.  The thyroid nodule must be greater than or equal to 1 cm and the patient is 21 years or older.

If the Afrima Gene Xpression Atlas result is suspicious, DNA analysis for TERT will reflex automatically.

To opt out of both reflex testing options, please indicate on the NonGYN/FNA Cytology EPIC order or on the paper requisition. You may also contact the Cytopathology lab at 802-847-5136 to opt out of reflex testing.

Additional Codes

Epic Code Atlas Code Mayo Access ID Order LOINC Legacy Code
LAB N/A N/A N/A AFIRMA

 

Specimen Information

FNA Collections Procedure without On-Site Personnel for Rapid Evaluation:

Refer to the Resources on the Left for a Printable Copy of this information. 

  1. On the Afirma Patient Verification Card:
    1. Place a patient FNA order label containing two unique patient identifiers on the card, ensuring not to cover the large QR Code.
    2. Alternatively, two unique patient identifiers may be written onto the patient verification card.
  2. The following triage of FNA passes is followed:
    1. Pass 1 for cytology
    2. Pass 2 for Afirma
    3. Pass 3 for cytology
    4. Pass 4 for Afirma
    5. Pass 5 for cytology.
    6. Both Afirma passes are collected into one FNAprotect tube.
      1. Rinse the needle after each pass.
      2. Invert the tube three times to mix once collections are complete.
  3. Select corresponding Nodule labels from patient verification card and write the patient’s initials on them in the required line.
  4. Apply a label to the FNAprotect tube, and any paper requisition submitted to the laboratory.

FNA Collections for On-Site Personnel: ROSE Triage:

  1. Collect three passes for each evaluation episode.
  2. When ROSE has confirmed the presence of adequate but indeterminate material (not clearly benign or malignant), two additional passes are collected for potential Afirma testing.
    1. Both Afirma passes are collected into one FNAprotect tube.
      1. Rinse the needle after each pass.
      2. Invert the tube three times to mix once collections are complete.
  3. On the Afirma Patient Verification Card:
    1. Place a patient FNA order label on the card, ensuring not to cover the large QR Code
    2. Select corresponding Nodule labels and write the patient’s initials on them in the required line.
    3. Apply a label to the FNAprotect tube, and Rapid Evaluation Form.   

Transport of FNAprotect Tube

  1. Insert the labeled FNAprotect tube into a purple top, glass slide holder and secure cap.
  2. Submit glass slide holder and other collected specimens to the Cytopathology Prep Room for processing.

    

 

Test Schedule / Analytical Time / Test Priority

Monday – Friday / 10 to 16 days / Not available STAT

Method

Gene Sequencing

CPT(s)

Description CPT
Onc Thyroid mRNA 10,196 gen alg 81546
TERT mRNA 81345

 

Section

Cytology

Performing Location

UVMMC via Reference Lab: Veracyte Labs

Is the UVMMC lab NY State Certified to perform this testing?  Yes/No

Yes

LOINC Code Information

N/A

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