Background:
The storage of purified high molecular weight DNA is applicable in situations where a confirmed or suspected genetic condition is evident and the possibility of future testing will be critically dependent on the analysis of specific samples. This procedure is particularly important in cases where an affected individual may be medically unstable. DNA will be extracted from the submitted specimen and stored for a minimum of ten (10) years. Molecular testing of stored DNA samples may only be performed with the written authorization of an ordering healthcare provider. Release of stored DNA for molecular testing at another institution will follow written authorization provided by the ordering healthcare provider which specifies the third party testing facility and their address. Laboratory policy for specimen handling, storage, and subsequent release of isolated DNA follow guidelines of the American College of Medical Genetics and adhere to provisions found under the Oregon Genetic Privacy Act.
Reasons for Referral:
DNA preparation and storage from individuals for whom future sample collection may be problematic.
Specimen handling and DNA storage in a licensed and accredited CLIA Laboratory.
Methodology:
DNA isolation from submitted specimens will be performed using standard nucleic acid extraction methods. DNA will be stored for a minimum of 10 years in a manner designed to preserve the viability and suitability of the specimen for future medical or diagnostic purposes.
Specimen Requirements:
Blood: EDTA or ACD (Solution A or B):
- Adult: 5 mL
- Child: 5 mL
- Infant: 2-3 mL
Saliva: 2 ORAgene Saliva Kits (OGR-500) used according to manufacturer instructions. Please contact KDL Client Services for a Saliva Collection Kit.
Assisted Saliva: 4 ORAgene™ Assisted Saliva Collection Kits (OGR-575) used according to manufacturer instructions. Please contact KDL Client Services for an Assisted Saliva Collection Kit for patients that cannot provide a blood sample.
Skin Fibroblast: Punch Biopsy (cell cultures will be prepared at KDL and used for testing), or 2 T-25 confluent flasks.
Prenatal:
- Direct Amniotic Fluid (10-20mL)
- Direct CVS
- Direct POC
- Cultured Amniocytes (2 T-25 flasks)
- Cultured CVS (2 T-25 flasks)
- Cultured Fetal Tissue: Product of Conception (2 T-25 flasks)
- Cord Blood (1-2mL)
Notice Regarding Molecular Genetic Testing on CVS or Amniotic Fluid Specimens:
- Maternal cell rule-out testing will be performed on all prenatal specimens received. Please provide maternal blood (or saliva) in addition to the fetal specimen. Additional charges apply for the maternal cell rule-out test.
For routine testing of blood and saliva (or DNA extracted from them), KDL does NOT accept samples from patients within two (2) weeks of a packed cell/platelet transfusion or within four (4) weeks of a whole blood transfusion. For extraordinary circumstances, where testing must be performed outside of the above windows, please contact our lab.
A requisition form must accompany all specimens. Contact Client Services with questions.
Test Performed (Days):
M - F
Turn Around Time:
Not Applicable
Shipment Sensitivity Requirements:
- Package and ship specimen to remain cold, but not frozen.
- Ship via overnight express, using the FedEx priority overnight label provided.
- Contact Client Services for shipping kits and instructions at (855) 535-1522.
References:
Additional Info: