Acceptable Sample Types and Documentation, Storage, and Shipping Requirements
- Specimen tubes are required to have at least two unique patient identifiers (name, date of
birth, and/or medical record number (MRN)). This information must be attached to the body of
the tube directly containing the sample, not to the lid or any other part of the specimens
packaging. -
All samples must arrive with either a paper requisition or an electronic requisition.
Samples received without appropriate paperwork will be held for 5 business days. If
paperwork is not received within that time period the sample will be rejected. -
The accompanying requisition must have at least two unique patient identifiers that match
the identifiers on the tube. - Draw/Collection date and time of specimens must be included on accompanying paperwork
- If there is any breach of the container containing a sample (e.g., leaky containers, covers
that have fallen off, etc.), the specimen will be rejected.
Collection Container/ Tube requirements | Sample Volumes | Storage/Shipping of Specimens | |
Whole Blood [1] |
Preferred Container: EDTA (purple/lavender top) If EDTA is not available: NaCitrate (light blue top) or ACD (yellow top) will be accepted |
Infants (<2years): 2-3cc Children& Adults (>2years): 3-5cc |
|
Extracted DNA [2] |
Screw-top Microtainer |
Minimum of 10µg of DNA at a minimum concentration of 50 ng/µL |
|
Skin Biopsies[3] |
Biopsies must be transported in Chang-D, Hank, or saline solution.
|
3mm diameter punch biopsy that includes dermal tissue. |
|
Bone Marrow[4] |
Preferred Container: EDTA (purple/lavender top) If EDTA is not available: NaCitrate (light blue top) or ACD (yellow top) will be accepted |
Infants (<2years): 2-3cc Children& Adults (>2years): 3-5cc |
|
Specific Sample Requirements
Samples that appear to have been frozen will be accepted but quality of DNA extracted or testing
will not be guaranteed.
- The extraction method used to produce the DNA sample and the original source of the
specimen must be provided with the sample. - Claritas uses QiagenTM Extraction Kits for DNA extraction. All clinical validation is based
on using DNA isolated by this method. If a method other than the QiagenTM Extraction Kit was
used, prior consultation with the laboratory is recommended in order to determine whether
the sample can be accepted. Please call 617-553-5880 to discuss alternate DNA extraction
methods. - DNA extracted in research laboratories will not be accepted except under extenuating
circumstances (e.g., this is the only sample available and there is no ability to obtain a
new sample). If you plan to send DNA extracted in a research lab, Claritas must be contacted
prior to sending the sample or it will be rejected. Please call 617-553-5880 to discuss
sending research DNA.
- Additional sample types may be accepted following consultation with the laboratory. Please
call 617-553-5880 to discuss prior to sending the sample. - Skin biopsy samples smaller than 3mm may be accepted on a case by case basis, but cannot be
guaranteed to be successful or provide results comparable to testing/culturing done with
larger tissue samples. - If a skin biopsy sample arrives in a state other than room temperature, it may be
rejected.
- Bone Marrow samples will be accepted for GATA1 testing only.
Shipping Information
Samples should be sent to:
Claritas Genomics
Attn: Specimen Processing
99 Erie Street
Cambridge, MA 02139
All specimens should be packed and shipped according to US Department of Transportation (DOT)
and International Air Transportation Association (IATA) regulations.
Please consult the
shipping guidelines before packing specimens.
Shipments should include a completed
Non Diagnostic Consent form,
Requisition form,
and Muscular
Dystrophy Sequencing Panel Clinical Questionnaire
if applicable for each specimen.