Toll-free (North America): 1.866.813.6354 Tel.: 613.723.5757 • Fax: 613.723.5057 www.dnagenotek.com [email protected] Collection device catalog #: OCD-100A For more information contact [email protected] Sample ready for transport, storage and processing DNA Genotek Inc. 3000 - 500 Palladium Drive Ottawa, ON, Canada K2V 1C2 Subsidiary of OraSure Technologies, Inc. For In Vitro Diagnostic Use DNA from Saliva EASY • PAINLESS • PROVEN OCD-100/OCD-100A Collect high quality DNA samples for molecular diagnostics ORAcollect®•Dx is a robust, painless and easy-to-use DNA collection kit. ORAcollect•Dx is designed to collect, stabilize and protect DNA samples. Unlike buccal swabs, ORAcollect•Dx samples yield larger amounts of high quality human DNA and integrates easily into existing laboratory workflows. DNA collection with ORAcollect•Dx provides: • A fast, easy and reliable DNA sample with no drying time required • Stabilized DNA at ambient temperature • High quality DNA for use in downstream molecular applications • Flexible processing with seamless integration into existing workflows ORAcollect•Dx is an FDA cleared device † . Molecular diagnostic and laboratory developed test manufacturers can reduce the time and regulatory burden of their own FDA submissions by leveraging the 510(k) clearance of ORAcollect•Dx.
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Toll-free (North America): 1.866.813.6354Tel.: 613.723.5757 • Fax: [email protected]
Collection device catalog #: OCD-100A
For more information contact [email protected]
Sample ready for transport, storage
and processing
DNA Genotek Inc.3000 - 500 Palladium DriveOttawa, ON, Canada K2V 1C2Subsidiary of OraSure Technologies, Inc.
For In Vitro Diagnostic Use
DNA from SalivaEASY • PAINLESS • PROVEN
OCD-100/OCD-100A
Collect high quality DNA samples for molecular diagnostics
ORAcollect®•Dx is a robust, painless and easy-to-use DNA collection kit. ORAcollect•Dx is designed to collect, stabilize and protect DNA samples. Unlike buccal swabs, ORAcollect•Dx samples yield larger amounts of high quality human DNA and integrates easily into existing laboratory workflows.
DNA collection with ORAcollect•Dx provides:
• A fast, easy and reliable DNA sample with no drying time required
• Stabilized DNA at ambient temperature • High quality DNA for use in downstream molecular
applications• Flexible processing with seamless integration
into existing workflows
ORAcollect•Dx is an FDA cleared device†. Molecular diagnostic and laboratory developed test manufacturers can reduce the time and regulatory burden of their own FDA submissions by leveraging the 510(k) clearance of ORAcollect•Dx.
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Easy collection
For In Vitro Diagnostic Use
Superior samples • Proven performance
PD-BR-00192 Issue 5/2017-06 © 2017 DNA Genotek Inc., a subsidiary of OraSure Technologies, Inc., all rights reserved.
Cwww.dnagenotek.com
ORAcollect®•Dx has been cleared for in vitro diagnostic use in the U.S.A.† FDA cleared for in vitro diagnostic use with the eSensor® Warfarin Sensitivity Saliva Test. ®ORAcollect is a registered trademark of DNA Genotek Inc. All other brands and names contained herein are the property of their respective owners.
Patent (www.dnagenotek.com/legalnotices)
1 2 3 4
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10 x
Place sponge comfortably in mouth and rub lower gums
10 times back and forth.
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10 x
Repeat rubbing motion on the opposite side
of the mouth.
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10 x
Holding the tube upright, unscrew the cap from
the tube.
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10 x
Turn the cap upside down, insert the sponge into
the tube and close tightly.
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10 x
Invert the capped tube and shake vigorously 10 times.
FeaturesORAcollect•Dx is a superior alternative to buccal swabs and offers several advantages: • Collection of sample is simple and gentle for donor• Efficient collection is ideal for clinical workflows• DNA integrity is maintained at ambient temperature for transportation via regular post • Bacteriostatic reagent inhibits growth of bacteria from time of sample collection to processing • Liquid sample (no cutting of tips) eliminates manual steps, reduces the chance of errors and
cross contamination, while facilitating efficiency in the lab• High quality DNA sample enables downstream analysis with proven clinical utility• Format optimizes laboratory efficiency
– Use with liquid handling robots – Minimal hands on technician time – Compatible with standard labware – Integrated barcode on tube for workflow efficiency and sample traceability
Collection method comparison
Attributes Buccal swabs ORAcollect•Dx
No drying time required Specimen stability at ambient temperature days months
Liquid sample Standardized format for high-throughput processing Eliminates cross contamination Integrated barcode for sample traceability FDA cleared Microbial contamination To = 14%, T30 days = 24%‡ To = 4%, T60 days = 4%**
Median yield 0.7 µg‡ 2.6 µg*
Molecular weight < 23 kb‡ > 23 kb‡‡ Panford-Walsh R., Doukhanine E. and Bouevitch A. (2011). Comparison of DNA from samples collected using ORAcollect•DNA (OCR-100) vs. buccal swabs.
DNA Genotek. PD-WP-00021.* Data was obtained by testing 156 samples from 156 donors and DNA was extracted using the QIAamp® DNA Mini kit (QIAGEN®). ** Data was obtained by testing 30 samples from 30 donors.
OCD-100A kit contents
PackagingCollector
Product specificationsPre-use with packaging: Dimensions: 10.2 × 24.1 × 1.8 cmWeight: 11 gShelf-life: 24 months
Post sample collection specificationsStorage conditions: Room temperatureSample stability: 60 days
For full specifications on weight and dimensions, refer to PD-BR-00240 on our website.
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