Conducting quality skin punch biopsies in a safe, effective manner is a key part of the diagnostic process. Please review the quick reference guide below when using the CND Skin Biopsy Test Kit. If you have any questions, please call 480-569-2900.
Preparation
- Complete the requisition and patient financial responsibility forms and obtain patient consent (form included)
- Make sure the CND Skin Biopsy Test Kit has not expired
- Gather additional materials required for the biopsy – gloves, needles, tuberculin syringes, and local anesthetic (recommended 1% lidocaine with epinephrine)
- Lay out the contents of the sterile skin punch pack on a clean, flat surface or tray near the patient
- Fill out each label with the patient’s name, date of birth, date of biopsy, biopsy side, and biopsy site before affixing the label to the vials
- Make sure the patient’s full name and date of birth on the vials match the requisition form
- Patients should lie in a prone position or on their side
- It is important to collect tissue from three specific biopsy sites1
- Posterior Cervical – 3 cm laterally from C7 vertebrae
- Distal Thigh – 10 cm above the lateral knee
- Distal Leg – 10 cm above the lateral malleolus
Procedure
- Clean each biopsy site with the provided alcohol prep pad
- Inject local anesthetic creating a small wheal, similar to a tuberculin skin test
- Wait a minimum of 15 seconds and a maximum of 10 minutes to achieve adequate analgesia
- Apply gentle pressure while twisting the punch biopsy tool until the metal head is fully inserted into the skin Remember – the tip of the tool is very sharp and should be handled with care
- Remove the tool and use the forceps to gently grasp underneath the epidermal layer. Be careful not to pinch the epidermal layer, as this can cause damage to the nerve fibers
- If needed, use the scissors provided in the kit to release the specimen from underlying tissue
- If the biopsy remains in the tool, use the metal probe to gently push it out and into the correctly labeled vial
- Make sure the specimen is placed into the vial with the corresponding biopsy site on the label
- The biopsy should be submerged and free-floating
- Cover the biopsy site with gauze and the bandage provided
- Repeat the steps for each of the remaining biopsy sites
- Place all vials in the biohazard bag included in the kit and prepare for shipping
- Advise patients to keep the biopsy sites clean and dry for 24 hours
Shipping
- Package specimens in the biohazard bag and place them inside the bubble mailer along with the completed requisition form, patient financial responsibility form, and supplemental documentation (patient insurance card(s) – front and back, patient demographics or face sheet, relevant chart notes)
- Put the bubble mailer into the FedEx UN3373 Pak and affix the prepaid overnight shipping label
- Call FedEx at 1.800.463.3339 for same-day or next-day pickup or drop-off at your nearest FedEx location
- Please note and save the tracking number from the label for your records
- CND highly recommends that biopsies are shipped the same day they are collected or the next morning at the latest
Precautions
The skin punch biopsy procedure should always be performed by an appropriately licensed clinician. The Syn-One Test is not recommended for individuals with compromised skin or open wounds, clinical evidence of severe vascular disease (history of ulceration, poor wound healing, vascular claudication), or a history of allergic reaction to local anesthesia. For patients receiving dual anti-platelet or anticoagulation therapies, to reduce bleeding risk, the clinician may choose to*: (1) delay the biopsy procedure until the patient is no longer taking these therapies, (2) apply local anesthetic with epinephrine (a vasoconstrictor) to help control blood flow to the biopsy site, or (3) apply localized pressure (and/or an additional bandage or use compressive bandage) if necessary and monitor to ensure adequate management of bleeding.
1.Gibbons CH, Levine T, Adler C, et al. Skin biopsy detection of phosphorylated α-synuclein in patients with synucleinopathies. JAMA. 2024;331(15):1298–1306. doi:10.1001/jama.2024.0792
*CND’s Synuclein-One Study published in the Journal of the American Medical Association (JAMA), April 16 2024, reported an adverse event rate of 0.5% (N=428) associated with post-biopsy bleeding. The study population excluded patients receiving dual anti-platelet or anticoagulation therapies for this specific study protocol.
FAQs
Do I have to use 1% lidocaine with epinephrine?
Lidocaine can be used with or without epinephrine for the local anesthetic. Other lidocaine-equivalent local anesthetics may be used for the skin biopsy procedure, including but not limited to Marcaine, Xylocaine, etc.
How long does it take to anesthetize each site?
It takes a minimum of 15 seconds and a maximum of 10 minutes after the anesthetic is administered to achieve adequate analgesia.
Can I use a different needle size to inject the anesthetic?
We recommend a 30-gauge needle to inject 1cc of lidocaine with epinephrine. However, a smaller size needle (i.e., higher gauge) may be used at the clinician’s discretion.
Do I need to collect all three biopsies?
We highly recommend collecting one specimen from each of the standard biopsy sites. The sensitivity of our tests is maximized with these three specimens.
We invite you to watch a short narrated video providing a walk-through of the skin biopsy procedure and protocol.
For Clinicians: Request a Skin Biopsy Test Kit
Our suite of neurodiagnostic tests provides clinicians with objective pathological insights on diseases that are often difficult to diagnose. Using our Skin Biopsy Test Kit, collect three small skin biopsies from your patient, send them to our CLIA-certified and CAP-accredited lab, and CND will provide important pathological insights to support a diagnosis.
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