Sample Requirements and Shipping Information
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
We receive samples Monday through Friday.
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.