Specimen and shipping requirements

Test type

Accepted for the following test types:

• Diagnostic testing (panels and exome)
• Proactive health panels
• Carrier screening

Specimen types

Specimen types accepted:

• Whole blood
• Cord blood, collected at birth (but not prior to birth)—we recommend that you perform MCC analysis if you have concerns about maternal cell contamination for a given specimen
• Frozen or partially frozen blood, although deletion/duplication analysis is not guaranteed for these specimens; also note that these specimens will be thawed upon receipt

We are unable to accept:

• Hemolyzed or clotted blood
• Blood (or saliva) from patients who have had an allogeneic (non-self donor) bone marrow transplant.
• Blood (or saliva) from patients who have had an allogeneic (non-self donor) stem cell transplant.
• Blood (or saliva) from patients who had a blood transfusion less than two weeks prior to specimen collection

Hematologic malignancy:

Results may be affected for blood or saliva samples from patients with hematological malignancies that are actively circulating in the peripheral blood. In such cases, a specimen type not derived from blood or saliva is suggested, such as gDNA from a skin biopsy. Please see the "DNA" tab above for more information and click here to learn more.

VOLUME

For adults:

• We require a minimum of 3 mL of whole blood per clinical area for adults.

For pediatric cases:

• We prefer 3 mL per clinical area, but can accept 1.5 mL if necessary.

For newborns/infants:

• We accept small-volume microtubes (0.5-mL capacity) from capillary blood collection (heel or finger stick). We require 3 full small-volume tubes per clinical area.

Container

Containers accepted:

• Specimens should be sent in EDTA purple-top or pink-top tubes. We accept both K2EDTA and K3EDTA.
• Please see the post-mortem specimens tab for details on gray-top tube specimens.

Labeling

Each tube must be labeled with:

• The patient’s full name
• One additional unique identifier:
  • Date of birth
  • Medical record number
  • IB number, if placed by submitting clinician
  • Invitae test order ID (RQ#)
  • Medical record number
• Specimen collection date

The patient name and at least one additional unique identifier written on each tube must match the name and identifier provided when the test order was placed. We recommend including more than one additional unique identifier to ensure a match.

Storage & Stability

We recommend using overnight shipping the same day that the blood is collected.

• Blood can be kept at room temperature for up to 48 hours.
• We request that blood is refrigerated no longer than two weeks.
• Please do not freeze blood as deletion/duplication analysis is not supported for frozen or partially frozen blood.

Documentation

A printed copy of the online requisition form must be submitted with the specimen. You will be able to print a copy of the requisition form after you have completed the online requisition process.

Shipping requirements

Blood should be shipped overnight at room temperature. We recommend including cold packs when shipping from outside the US and Canada in hot weather or if shipping is expected to take longer than overnight to keep the specimen at 2 to 8 degrees Celsius (35.6 to 46.6 degrees Fahrenheit). Frozen blood should be shipped overnight using cold packs.

To assist with specimen collection and shipping, you can request a free Invitae blood collection kit by submitting our online Request a Kit form.

If you are sending more than one kit in a given day to Invitae, you can include up to four kits into the same FedEx Clinical Pak envelope for your convenience. If multiple kits do not fit well into a single envelope for any reason, please separate them into as many envelopes as needed.

Alternatively, you can send us the specimen in a crush-proof container via FedEx Priority Overnight (in accordance with the FedEx Packaging Guidelines for Clinical Samples). Please contact Invitae’s client services team to obtain the FedEx account number. (Please note that pricing outside the US does not include shipping fees.)
        Shipping address:
        Attn: Client Services
        Invitae Corporation
        1400 16th Street
        San Francisco, CA 94103

Invitae accepts packages Monday through Friday. We recommend that you send your package so that it leaves your facility Monday through Thursday. Please do not request Saturday delivery. Invitae follows the FedEx Holiday Service Schedule.

If you ship your specimen from outside the United States, your shipping carrier will require three copies of a commercial (pro-forma) invoice. A sample invoice is available here. Please be sure to also include a customs declaration form. A sample customs declaration form is available here.

Test type

Accepted for the following test type:

• Preimplantation genetic testing

Embryo biopsies are accepted for preimplantation genetic testing for chromosomal aneuploidy (PGT-A) and structural rearrangements/translocations (PGT-SR). PGT-SR is accepted on a case by case basis and requires a completed PGT referral form and approval from Invitae’s medical team prior to sample submission.

Please see the complete guide to biopsy and shipping instructions for PGT.  

Specimen types

• Invitae PGT can be performed on trophectoderm/blastocyst biopsy samples only.
• No fresh transfers can be accommodated.
• All samples must arrive in the Invitae tubes (0.2 mL) provided.
• All samples must arrive in ~2.5 to 3.5 μL of the Invitae buffer provided.
• All samples must be frozen prior to shipping and remain frozen during the shipping process. Samples stored at room temperature may render samples unable to be tested.
• All samples must be received within two weeks of biopsy.
• All samples must be shipped on dry ice.

Specimen quality

The success of genetic testing is dependent on specimen quality. While we make every effort to generate complete test results, this may not always be possible if a specimen is of poor quality. For the best test outcome, please follow your laboratory’s standard sterile procedures and the steps listed below.

Labeling

Prior to loading the samples in the rack, use a permanent marker to clearly label the tube cap and the sidewall with the appropriate embryo # and complete the Biopsy worksheet form included in your kit.  All columns must be complete and legible so that sample processing is not delayed. Once samples are placed in the rack inside the Invitae kit, please follow these labeling instructions:

• Affix the large Invitae barcode sticker to the outside of the rack and label with the patient’s name and DOB.
• The medium barcode stickers are for any patient-related paperwork included in the shipment (e.g., the Biopsy worksheet form, Patient consent form, Test requisition form, etc.).
• The small barcode stickers should be used to associate each tube with the appropriate rack. Each sticker should be wrapped around the tube so that it sticks to itself. Please ensure that the embryo # is visible on the sticker and the top of the tube.

Storage & Stability

Prior to use, the Invitae PGT kit and its components may be stored at room temperature. Immediately place the Invitae rack upright in a freezer once samples have been added to the rack.

• Invitae buffer will turn yellow to indicate that it is frozen.
• Samples may be stored frozen for up to one week.
• When ready, ship on dry ice to Invitae. Request dry ice >
  
Please note, dry ice delivery requires at least 48 hours advance notice.
  It is not available for clients outside the United States.

Documentation

PGT samples cannot be processed without:

• Test requisition form
• Biopsy worksheet form (included in kit)
• For PGT-SR, a completed PGT referral form and medical review is required before sending samples

Shipping requirements

• Ensure all samples remain frozen prior to shipping, indicated by the YELLOW buffer color.
• Keep the Invitae rack upright in the styrofoam container. Fill the container with tightly packed dry ice pellets. Place the styrofoam container in the kit (cardboard shipping box).
• Complete the dry ice label on the outside of the kit and affix the FedEx shipping label to the top of the kit. Ensure the FedEx label AND the outside of the kit include the total weight of the shipment in kilograms. Any missing information may result in returned shipments.
• Kits:
  • You may ship up to two racks (two patients’ worth of samples) in one small kit.
  • You may ship up to five racks (five patient’ worth of samples) in one large kit.
• We do not accept shipments on Sundays. Please ensure your shipment arrives Monday-Saturday, otherwise your shipment may be rejected.
• Please send your sample within two weeks of biopsy. Ship samples for overnight delivery to:
  
          Invitae Corporation
          1400 16th Street
          San Francisco, CA 94103

If you are shipping your specimen from outside the United States:
Shipping costs and dry ice coordination are the sender’s responsibility. Your shipping carrier will require three copies of a commercial (pro-forma) invoice. A sample invoice is available here. Please be sure to also include a customs declaration letter. A sample customs declaration letter is available here.