Test Instructions/Logistics – How is the test administered and the sample returned?
The contents of the kit include: Outer shipping box, Styrofoam insulated box, (4) Specialized 10 mL tubes, Biohazard bag, Absorbent material, bubble wrap,Tyvek envelope, 2 or more Temperature Control Paks (2-4 will be sent during summer and winter months), blood draw and shipping instructions, overnight shipping label (pre-paid).
TUBES AND TEST KITS MUST BE STORED AT ROOM TEMPERATURE AT ALL TIMES (59-86 °F).
- ROOM TEMPERATURE GEL PAKS are included in the kit. These Paks must be conditioned at room temperature for 24 hours prior to shipping. Do not refrigerate or freeze the Paks. We suggest you keep the tubes, gel Paks and blood samples at room temperature at all times. We also suggest that you open the Styrofoam holding container to allow room temperature air to reach the Paks. Note: If the gel Paks arrive at your site frozen, you may choose to put them in a water bath of room temperature water to decrease the time required for use.
- DO NOT FREEZE WHOLE BLOOD SAMPLES. Freezing will break open blood cells in whole blood samples and render the sample useless.
- DO NOT USE DRY ICE. Shipping on dry ice is not necessary with the specialized cell-free DNA collection tubes and the Temperature Control Paks.
Use ONLY the tubes which are included in the IvyGene test kit.
- Four (4) specialized 10 mL tubes containing a stabilizing agent for cell free DNA are included in the IvyGene test kit. NO OTHER TYPE OF TUBE may be used. Store the tubes in the kit at room temperature at all times.
Ship the sample overnight.
- Order test kits approximately one week in advance of the blood draw.
- Temperature Control Paks must be conditioned at room temperature for at least 24 hours prior to shipping.
- An overnight pre-paid shipping label is included in the kit.
- SHIP AND DRAW SAMPLES MONDAY-THURSDAY ONLY.
BLOOD DRAW INSTRUCTIONS
- Dietary requirements: No dietary restrictions are required.
- Label EACH TUBE: Label each tube with the unique ID from the Requisition Form and the patient DOB
- Amount of blood needed: 40 mL (10 mL in each of the 4 tubes)
- Collect sample using standard venipuncture technique.
- Invert blood tubes: Per label instructions, the blood tubes need to be inverted by hand multiple times to ensure the blood specimen mixes with the stabilizing reagent.
How long can I keep the blood sample before I ship it?
The sample must be stored in the specialized tubes at room temperature and shipped within 24-48 hours. Temperature Control Paks must be conditioned at room temperature for at least 24 hours prior to shipping. If the Paks arrive frozen to your facility, they may require additional time, or need to be put into a room temperature water bath as needed.
How do I pack the sample in the kit to ship it back?
- Shipping Box. Use the same IvyGene outer shipping box and the Styrofoam insulated box inside.
- Temperature Control Paks. Place one Temperature Pak in the bottom of the Styrofoam insulated container. Make certain the Pak is at room temperature for at least 24 hours before packing.
- Biohazard bag. Place Specialized Tubes with whole blood sample (at room temperature) in the Biohazard bag along with the absorbent material included in the kit. Remove the adhesive tape and seal the Biohazard bag. Note: Make certain each tube is labeled with the UID from the Requisition Form and the patient DOB.
- Bubble wrap. Wrap the Biohazard bag and tubes with the bubble wrap included in the kit.
- Tyvek envelope. Place the bubble wrapped sample into the Tyvek envelope and seal the envelope.
- Requisition Form. The Requisition Form included in each kit MUST BE COMPLETED AND SIGNED and returned. Fold the Requisition form and place it on top of the Tyvek envelope.
- Temperature Control Paks. Place the second Temperature Control Pak that was included in the kit on top of the Tyvek envelope and Requisition Form. Make certain it is at room temperature.
- Additional Temperature Control Paks. Any additional Temperature Control Paks provided (up to 4 depending on the season) should be placed on either side of the Sytrofoam insert.
- Stryrofoam box lid. Place the Styrofoam box lid securely on top.
- Shipping box. Remove previous shipping labels. Close and tape the shipping box.
- Overnight pre-paid label. Place overnight label on the shipping box.
- Shipping Address: The shipping address is on the Overnight Label. It is:
- Mor-NuCo Enterprises Laboratory, 1201 Cumberland Avenue, Suite B, West Lafayette, IN 47906.
- Call FedEx for a pick-up.
May I use a different type of tube or one I already have in my office?
NO. THE SAMPLE MUST BE DRAWN IN TUBES PROVIDED IN THE KIT. These are specialized tubes containing a stabilizing agent for cell free DNA. Any other type of tube will render the sample useless.
What if the specialized tubes have expired or has been stored outside the range of room temperature?
DO NOT USE THE TUBES. Contact IvyGene at 844-489-4363 and we will ship you another kit.
How do I know that the sample was received at the laboratory?
You may check the sample status at [email protected] Please have the following information available and included in your original email to expedite the process:
Results will be returned to the prescribing physician. A result status will only provide the received date and expected result return date.