Collection & Shipping

Our specimen requirements are listed in the categories below. Test-specific requirements may be found on the test instructions website page. Please follow these directions when submitting your specimen(s) to ensure successful testing and avoid delays.

Please label each specimen and Test Requisition Form with at least 2 unique identifiers specific to the patient (full name and date of birth/medical record number), and collection date.

Packaging should comply with International Air Transport Association (IATA) criteria (http://www.iata.org). If ground overnight is used for FFPE samples, then shipment should conform to ground transportation standards (eg, Department of Transportation packaging standards, if in the US). The shipping box should be secured and appropriate stickers should be placed, such as “Biologic Substance, Category B UN 3373,” and the type of shipment (eg, next day). The IATA shipping category appropriate to the specimens collected should be used, both in labeling and in the training required for packaging. In addition to “Biologic Substance, Category B,” other IATA categories include “Exempt Human Specimens” and “Infectious Substance, Category A.”

Consult the latest IATA regulations to determine which category best applies to the specimens. Do not write the term “diagnostic specimens” on the box: revision of the IATA regulations has replaced the term “diagnostic specimens” with “Biologic Substance, Category B.” Biologic substances and specimens are subject to specific packaging requirements and there should be no misunderstanding about the contents of the shipment, particularly with regard to risk for infection of humans or animals. A completed material submission form from the trial needs to be submitted along with the specimens

Sample Type: Collection and Shipping Instructions

Blood Collections:

EDTA tube (purple top) or PAXgene® DNA tube (blue top) preferred. For RNA based collections, EDTA tube (purple top) or PAXgene® RNA tube (blue top) preferred.

Adult: 3-4cc (1 full tube)
Pediatric: 2cc minimum
Newborn/Fetal/Cord blood: 2cc minimum

Storage

Preferred: Room temperature at 15-30°C
Alternatives: Refrigerated at 2-8°C
Frozen at -20°C ship on dry ice, avoid freeze/thaw cycles. Freezing may impact specimen quality

Stability

When stored per above, stable for 7 days. Please contact PacificDx if your sample is more than 7 days old.

Shipping

For whole blood, ship ambient with cold pack for 2-day delivery (preferred) using PacificDx Sample Submission Kit, or similar. Please do not ship to arrive on a holiday.

Buccal / Saliva Collections:

Container

Oragene (OGD-510 or OGD-500) self-collection container for Oncology, Rare Disease and Cardiology tests.
Oragene (OGR-575) assisted collection containers for all pediatric testing kits.

Amount

Oragene OGD-510 (1ml) or Oragene OGD-500 (2ml): 1 tube of freshly collected saliva in container per kit’s specific instructions. Fill up to black line with saliva and close lid. Once lid is closed, it automatically adds pre-measured buffer to complete the collection.
Oragene (OGR-575): 2 tubes of freshly collected saliva in container per kit’s specific instructions. Follow instructions for swabs and close lid. Once lid is closed, it automatically adds pre-measured buffer to complete the collection. Collect and send two (2) OGR-575 devices.

Storage/Stability

Pre-collection: Store kits at room temperature for up to 30 months.
Post-collection Storage: Room temperature at 15-30°C for up to 7 days.

Shipping

Ambient, preferably on cold pack for two-day delivery.

FFPE Slides and Blocks:

For Tissues analysis, FFPE Tissue Blocks are the preferred sample type versus slides. If sending unstained slides, please send a minimum of 10-15 slides, freshly cut at 4-6 microns. Archival cut slides are acceptable if less than 30 days old
Each unstained FFPE slide must have an unbaked 4 μm section on a positively charged slide. Make sequential sections; label all slides with the slice number (№ 1 from the top, etc.) and ID of the sectioned block
For NGS: 10 unstained slides + 1 H&E slide.
For IHC: 3-5 slides
For biopsies and excision tissue, we recommend following CAP/ASCO guidelines with cold ischemia time < 60 minutes and 10% neutral buffered formal fixation between 6-72 hours. For more information see CAP/ASCO Recommendations. JCO 2013;31:3997-4013.

Storage/Stability

Blocks should be less than 1Yr old
Archival cut slides are acceptable if less than 30 days old
Post-collection Storage: Room temperature at 15-30°C

Shipping

Ambient, preferably on cold pack for two-day delivery.