DISCERN™ Kit Instructions

Thank you for ordering the DISCERN kit for your patient diagnosed with dementia.

Listed below are the instructions for how to use the DISCERN™ kit to collect the skin punch biopsy and prepare the sample for transport back to our laboratory.  Please read the entire document before unpacking the DISCERN™ biopsy kit.

WHAT YOU NEED TO KNOW BEFORE YOU START

    • The DISCERN™ kit has been provided to you for use with a prequalified patient. SynapsDx has performed an insurance assessment for the patient identified on the Patient Authorization form and disclosed the findings to the ordering physician and has agreement to perform the test.  Using this kit with a different patient may result in significant out of pocket costs for the patient based on their specific insurance coverage.
    • In order to protect the viability of the samples, biopsy procedures should not be performed on Fridays or before holidays. Samples must be received within 48 hours of biopsy.  Please schedule biopsy procedures Monday – Thursday and ship no later than close of business on Thursdays.
    • Transport media will have a label with an expiration date. If dating of the transport media is expired or near expiration, please call Synaps Dx at 301-294-7026. Samples received with expired media will not be processed for culture.
    • Transport media feeds the biopsy during transportation and must be kept cool to keep the biopsy viable.Therefore, immediately refrigerate the transport media upon receipt, maintaining a temperature of 2֯ – 8֯ C (35֯ – 46֯ F) until ready for the biopsy procedure.  The transport media should never be frozen.
    • The Sample Biopsy kit, Patient Authorization form and Biopsy Return kit boxes should be put aside and stored until you are ready to perform the biopsy procedure.
    • Video instructions for the Punch Biopsy procedure can be found at https://www.youtube.com/watch?v=siAe_2gN6jU
    • Refrigerate the biopsy after the procedure is done. The biopsy should be shipped back to Synaps Dx on the day of the procedure.

STEP 1: THE KIT

When you open the DISCERN™ Kit you will find the following three boxes and the Patient Authorization form:

  1. Biopsy Transport Media
  2. Biopsy Collection Kit
  3. Biopsy Return Kit

Immediately open the Biopsy Transport Media kit and inside you will see a tube containing the vial of transport media. Place the tube containing the transport media into the refrigerator.

Discard the ice packs and the insulated box.

The Biopsy Collection Kit contains the tools you will need to perform the biopsy and clean the biopsy sample. The kit contains three sterile containers, Dulbecco PBS, sterile suture kit, two pieces of parafilm, the biopsy punch, a bandage, an alcohol prep pad and a biohazard collection bag.

The Biopsy Return kit, together with the Patient Authorization form can be set aside until the patient appointment and does not need to be refrigerated. 

STEP 2: PREPARING FOR THE BIOPSY

  1. When you are ready to perform the biopsy with the patient in the room, the first step is to complete the Patient Authorization form. The form has two authorizations – one for you, (the clinician), and the other for the patient. Please sign and have the patient fill out all the necessary fields. 

    At the bottom of the form, you will find two label stickers. Please fill out the patient’s name, Date of Birth and date and time of biopsy procedure. 

    At the completion of the biopsy, one label will be affixed to the tube containing the biopsy sample that will be shipped back to the lab. The second label is extra if needed.

     When ready to perform the biopsy:

    1. Create a sterile field for working with the biopsy sample. You will place the biopsy tool with the skin sample, on the sterile field while you close and cover the incision from the punch biopsy.
    2. Remove the vial containing the Transport Media from the refrigerator and place in the sterile field.
    3. The tube containing the sample transport media is comprised of three pieces:
      1. outer plastic tube
      2. insulation sleeve
      3. vial containing the transport media
    4. Remove the vial containing the sample transport media from the outer tube and take off the insulation sleeve.  Set these components aside on the sterile field.
    5. Remove the lids from the three sterile containers and pour 1/3 of the Dulbecco solution into each of the three sterile containers and place the three containers on the sterile field.

STEP 3: THE BIOPSY

The most popular areas are the inside portion of the upper arm. Avoid fatty/wrinkly areas that can result in a fatty biopsy collection, rendering the sample unviable.

  1. Cleanse the biopsy area with antiseptic (i.e., betadine) and then anesthetize near the biopsy site with 2% lidocaine – may use a 30-gauge needle to limit discomfort.
  2. Stretch the biopsy site with your index finger and thumb comfortably. Then, hold the biopsy punch instrument vertically over the skin and press downward and rotating clockwise using a twirling motion created by the first two fingers on the dominant hand.
  3. Once the instrument has penetrated the subcutis layer (the dermis), pull the tool back out with the sample in the biopsy punch.  Scissors may be used to cut the specimen below the level of the dermis as needed.

You may use this video as an instruction for the biopsy process: https://www.youtube.com/watch?v=siAe_2gN6jU

After you perform the biopsy, you may place the biopsy tool containing the sample on the sterile field while you attend to the patient to close the biopsied area.

STEP 4: AFTER THE BIOPSY PROCEDURE

How to clean the sample and prepare for return shipping.

  1. Press the pink plunger at the top of the punch biopsy tool to release the skin sample onto the tweezers provided.
  2. To remove blood from the skin sample,
  3. Hold the skin sample in the tweezers,
  4. Dip and swirl the sample in each of the three sterile containers consecutively that you prepared with Dulbecco solution prior to the biopsy procedure. This step cleans any blood from the sample.
  5. This should be a quick wash in each container. 
  6. Once you have completed cleaning the sample, place the cleaned skin sample in the sample transport media vial. The solution in the sample transport media will keep the sample viable during transport.  Affix patient label lengthwise to the transport media vial so the patient information and bar code are showing.
  7. Screw on the cap to close the vial.
  8. Peel the backing from the parafilm and wrap the parafilm around the cap of the vial creating a tight seal. 
  9. Wrap the vial with the insulation sleeve and place them into the outer tube, cap first. 
  10. Place the wrapped vial into the plastic tube with the pointed end of the vial facing you.  Close the plastic tube with the cap provided.
  11. Open the biohazard bag, place the plastic tube containing the transport media into the bag and seal the bag. 
  12. Fold and place the Patient Authorization Form in the document sleeve of the biohazard bag and place the bag in the refrigerator until ready to ship. Samples should be shipped on the same day as taken.

STEP 5: Shipping the sample

  1. Take the Biopsy return kit. Lift up NanoCool lid from the box and place it and the prepaid return label to the side. The NanoCool device is a chemical cooling pack that once activated, will keep the sample in the proper temperature range during transit back to the SynapsDx Laboratory.
  2. Do not press the button on the NanoCool until you are ready to seal the box.  Please read the NanoCool instruction sheet contained in the Return Kit.
  3. Place the biohazard bag containing the Biopsy sample and the Patient Authorization form into the insulated box.
  4. Press the button on the NanoCool. When pressing the button, press firmly and keep pressure on the button for a few seconds.  Once activated, the blue NanoCool logo appears next to the button. This shows the NanoCool system is working. 
  5. Place the NanoCool unit with the button facing down towards the biohazard bag. 
  6. Close and seal the box with the tape provided. Affix the return overnight label to the top of the insulated box. The sample should be returned to SynapsDx on the same day as the biopsy was performed.
  7. Samples must be to the lab within 48 hours of biopsy. Therefore, please do not schedule biopsies on Fridays.

Thank you for ordering the DISCERN™ test for your patient!