Cell-Free DNA Collection Tube

Overview

The Cell-Free DNA Collection Tube is a direct-draw tube for the collection, stabilization and transportation of whole blood specimens. It effectively prevents blood coagulation, prevents cell lysis and preserves nucleated cells to enable efficient analysis of cell-free DNA (cfDNA). The Cell-Free DNA Collection Tube is available both in RUO* and CE-IVD** formats.

Benefits of Cell-Free DNA Collection Tubes

Preservation of cfDNA with a specially formulated solution that prevents cell lysis
Safety and durability through polyethylene terephthalate (PET) material
Reliability and support with >1 million tube usage worldwide
Supported by best-in-class Roche service, logistics and distribution network

Product Highlights

Specimen stability

Prevention of blood coagulation with K3EDTA
Preservation of nucleated cells and cfDNA
Better stability across transit and different temperatures

Safety and durability

Manufactured in accordance with ISO 9001 and EN ISO 13485
Easy-to-handle plastic tubes to reduce potential breakage, injuries and cost

View data showing comparable stability of minor cfDNA fraction across 7 days of transit, and equal, if not better stability at three different temperatures using Roche Cell-Free DNA Collection Tubes compared to another solution available in the market.

The Roche Cell-Free DNA Collection Tubes show comparable stability across 7 days of transit from samples collected for a noninvasive prenatal testing (NIPT) assay. Cell lysis decreases minor cfDNA fraction. Average and standard deviations of minor cell-free DNA fraction measured from 66,000 samples collected and stored using Roche Cell-Free DNA Collection Tubes compared to another product in the market across a 7-day period in ambient transit are shown.

Samples collected and stored using the Roche Cell-Free DNA Collection Tube show comparable, if not better, stability at three different temperatures. Cell lysis metrics measured across 359 samples (Roche n=147, Competitor n=212) at 370°C, room temperature (RT), and 40°C is shown.

*Research Use Only. Not for use in diagnostic procedures.
**Available for countries that accept CE-Mark.

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Specifications
Tube Type	Plastic (PET)
Tube Volume	8.5ml nominal liquid capacity
Shelf Life	18 months
Storage Temperatures	18°C - 25°C
Shipping Temperatures	15°C - 30°C
Manufacturing	In accordance with ISO 9001 and EN ISO13485

Technical Documents

Instructions for product use and other product-related technical documents

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Product	Pack Size	Catalog Number	How to buy
RUO Cell-Free DNA Collection Tube*	1 box of 50 tubes	07785674001	Contact Us
RUO Cell-Free DNA Collection Tube*	24 boxes of 50 tubes (1200 tubes total)	07832397001	Contact Us

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Product	Pack Size	Catalog Number	How to buy
CE-IVD Cell-Free DNA Collection Tube**	1 box of 50 tubes	07785666001	Contact Us
CE-IVD Cell-Free DNA Collection Tube**	24 boxes of 50 tubes (1200 tubes total)	07832389001	Contact Us
2-Pk Configuration CE-IVD Cell-Free DNA Collection Tube** (For Harmony Test Send Out users only)	1 box: 2 CE-IVD cell-free DNA tubes	08034290001	Contact Us
	25 individual boxes: Each box contains 2 CE-IVD cell-free DNA tubes	08034214001	Contact Us

*Research Use Only. Not for use in diagnostic procedures.
**Available for countries that accept CE-Mark.

The Harmony Prenatal Test is a non-invasive prenatal test (NIPT) based on cell-free DNA analysis and is considered a prenatal screening test, not a diagnostic test. Harmony does not screen for potential chromosomal or genetic conditions other than those expressly identified in this document. Before making any treatment decisions, all women should discuss their results with their healthcare provider, who can recommend confirmatory, diagnostic testing where appropriate. The Harmony Prenatal Test was developed, and its performance characteristics determined by Ariosa Diagnostics, Inc., a CLIA-certified and CAP-accredited clinical laboratory in San Jose, CA USA. This testing service has not been cleared or approved by the US FDA. HARMONY and HARMONY and Design are trademarks of Ariosa Diagnostics, Inc. in the US. HARMONY is a trademark of Roche in other countries. All other product names and trademarks are the property of their respective owners.