Specimen Kits
Kits can be ordered alone or together with other supplies, including Airbills, Clinical Lab Paks, Labels, and Requisition Forms.
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Specimen Requirements and Handling Procedures
Precision Oncology Liquid Biopsy DeepSightTM Collection Kit
Available Kit Components:
- 2 Blood ctDNA tubes (10 ml)
- 1 Biohazard bag (6” x 9”)
- 1 Ice gel pack
- DeepSight™ Requisition Form
- 1 FedEx clinical pak with label
siParadigm DeepSight™ Collection
Instructions
INTENDED USE
PAXgene Blood collection tubes are intended for the collection, storage, and transport of blood and stabilization of circulating cell free DNA (ccfDNA] and/or circulating cell free RNA (ccfRNA). Stabilized nucleic acid is isolated and purified from the blood plasma fraction for liquid biopsy testing and detection of clinically relevant genomic abnormalities in patients with diagnostically established, advanced stage cancers. This collection tube is NOT appropriate for downstream peripheral blood flow cytometry, conventional cytogenetic FISH, or chromosomal karyotyping studies; peripheral blood samples intended for primary diagnostic evaluation of suspected hematologic disorders, but inadvertently submitted in PAXgene collection tubes, may be rejected.
REAGENTS
PAXgene Blood ccfDNA collection Tubes contain anticoagulants as well as a proprietary stabilization additive without formaldehyde or formaldehyde releasing substances.
1- Collect specimen by venipuncture according to CLSI GP41.
2- Ensure that the PAXgene Blood ccfDNA Tube is at room tempera ture (15-25°C; 59-77°F). Do not refrigerate or freeze the blood tube prior to use.
3- PAXgene Blood ccfDNA Tubes should be collected last to avoid possible test result error due to additive carryover.
4- Collect 2 tubes of peripheral blood (10 mL per tube) from the patient.
PREVENTION OF BACKFLOW - Since PAXgene Blood ccfDNA Tubes contain a chemical additive, it is important to avoid possible backflow from the tube.
5- To guard against backflow, observe the following precautions:
- Place patient's arm in a downward position.
- Hold tube with the stopper uppermost.
- Release tourniquet as soon as blood starts to flow into tube.
- Make sure tube additives do not touch stopper or non-patient end of the needle during venipuncture.
6- Fill the tube to its maximum stated draw volume. Continue blood collection until vacuum is exhausted and blood has stopped flowing into the tube before removing the tube from the holder
7- After blood collection, gently invert the PAXgene Blood ccf DNA Tube 8 times to mix the blood with the additive. One complete inversion is defined as turning the filled tube upside-down, and then returning it to an upright position.
8- Do not shake vigorously since this may cause hemolysis.
9- After collection, store tubes within the recommended room temperature range (15-25°C; 59-77°F) until shipping and ship within 2 days at ambient temperature. Do not freeze the ice pack or the blood tube after collection.
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