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  • Products → Human Genomics → ORAcollect•Dx | OCD-100/100A

    DNA Collection Kits for Research and Diagnostics

    High-quality DNA saliva samples for genetic analysis or molecular diagnostics using the FDA-cleared ORAcollect®•Dx saliva collection device

    ORacollect.DX | OCD-100/100A

    Molecular test manufacturers could reduce the time and regulatory burden of their own FDA submissions by leveraging the 510(k) clearances of ORAcollect®•Dx device*.

    Both ORAcollect®•Dx and Oragene®•Dx saliva collection kits have FDA general clearance for prescription and OTC use. This designation allows these devices to be used by commercial partners and legally marketed with their therapeutics or devices in conjunction with their product's intended use.

    Both the ORAcollect®•Dx, and Oragene®•Dx devices allow saliva collection by an adult at home, without direction from a healthcare professional.

    Easy and reliable DNA collection with ORAcollect•Dx

    ORAcollect•Dx is a painless, non-invasive and easy-to-use DNA collection kit for self or assisted sample collection. ORAcollect•Dx is designed to collect, stabilize and protect DNA samples. DNA from ORAcollect•Dx can be used for research or genetic testing applications and clinical diagnostics. Unlike buccal swabs, collected samples are liquid based, bacteriostatic and integrate easily in existing lab workflows.

    Fast, easy, and reliable DNA sample collection in a clinic or at home

    • Quick, reliable and easy collection protocol with no drying time needed
    • High quality sample, the ORAcollect•Dx reagent is bacteriostatic and will inhibit the growth of bacteria from time of sample collection to processing
    • High quality DNA for use in downstream molecular applications
    • Full sample traceability with integrated barcodes
    • Liquid sample that enables:
      • use with liquid handling robots
      • compatibility with standard labware
      • easy processing
      • no cutting of tips
      • fewer manual steps reduces the chance of errors and cross contamination

    ✔ Proven quality
    ✔ Easy collection
    ✔ Stable at room temperature
    ✔ Standard mailing

    Pre-collection

    Intuitive design
    optimizes donor success

    chemistry
    fill-line

    Post-collection

    Effective format for transport,
    storage and processing

    dimensions
    automation-cap
    seal
    automation
    barcode

    Easy for users to comprehend instructions, comply with shipping instructions, and provide adequate samples with ORAcollect•Dx in a Direct-to-Consumer setting

    ORAcollect•Dx usability study for Direct-to-Consumer use (K212745)2:

    389 naive participants were mailed a sample collection device to their home. They were instructed to follow the instructions for use and return the collected saliva sample by mail.

    + 95% of participants demonstrated full compliance with shipping instructions and 99.5% of the specimens contained sufficient DNA after extraction

    + 100% of extracted samples had a call rate of 99.7% on the AAT genotyping test

    + 324 participants also returned a comprehension questionnaire and each question was answered correctly by 95% of the participants.

    Results of user comprehension, compliance with shipping instructions and sample adequacy demonstrate successful device use by naive users when used in a Direct-to-Consumer setting.

    Icon link to the complete donor instruction

    View donor user instructions for OCD-100  

    Icon link to the complete donor instruction

    View donor user instructions for OCD-100A

    ORAcollect•Dx versus Buccal swabs

    Buccal Swab Illustration ORACollect DX Illustration
    Attributes
    Buccal swabs
    ORAcollect•Dx (OCD-100/100A)
    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
    T0 = 14%, T30 days = 24%‡
    T0 = 4%, T60 days = 4%**
    Median DNA 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.

    Literature

    Data Sheets

    PD-BR-00192: ORAcollect•Dx (OCD-100) data sheet (pdf)

    PD-BR-00380: ORAcollect•Dx (OCD-100A) data sheet (pdf)

    PD-HB-00010: ORAcollect•Dx (OCD-100/100A) product handbook (pdf)

    MK-00098: Infographic – DNA from saliva vs blood. Who wins the cost battle?

    Protocols

    PD-PR-00840: prepIT•Q2A laboratory protocol for the preparation of genomic DNA from 100 μL of sample from ORAcollect•Dx (OCD-100A) (pdf)

    PD-PR-00835: Laboratory protocol for DNA extraction from ORAcollect®•Dx (OCD-100A) using QIAamp® DNA mini kit (pdf)

    PD-PR-00668: Laboratory protocol for DNA extraction from ORAcollect•Dx (OCD-100) using QIAmp DNA mini kit (pdf)

    PD-BR-00311: ORAcollect•Dx (OCD-100A) automation guide (pdf)

    Videos

    Calvin Harley, Ph.D., Telomere Diagnostics, shares his clinical research work into the impact of telomere length on health and aging.

    Processing of DNA Genotek saliva tubes on SARSTEDT Lab Automation (copyright SARSTEDT AG & Co. KG)

    Scientific Posters

    MK-00635: DNA from saliva: ORAcollect®•Dx performance as demonstrated through 510(k) validation studies (pdf)

    User Instructions

    Complete OCD-100 Collection Instructions

    Complete OCD-100A Collection Instructions

    Safety Data Sheets

    PD-MSDS-00021: ORAcollect•Dx (OCD-100) (pdf)

    Accessories

    Mailing Accessories

    Storage Accessories

    Branding & Packaging

    Barcoding

    …ORAcollect sample collection kits are providing us with the utmost in flexibility when we require a DNA sample … The quality of DNA is more than adequate to meet our needs.

    Ephraim Gazit, MD, Professor (emeritus) of Pediatrics
    Chaim Sheba Medical Center

    Speed your time-to-market with a complete end-to-end sample collection solution

    Our products can be fully customized to meet your time to market, streamlined end-to-end operational workflows, and branding requirements.

    * ORAcollect®•Dx (OCD-100) is FDA-cleared for in vitro diagnostic use, for prescription use (k152464) and over-the-counter (direct-to-consumer) use (k212745). FDA cleared for in vitro diagnostic use with the eSensor® Warfarin Sensitivity Saliva Test. FDA-cleared for OTC use with the AlphaID At Home Genetic Health Risk service

    2. 510(k) Substantial equivalence determination decision summary assay only template (510(k) number K212745). [View PDF]

    DNA Genotek's sample collection devices and nucleic acid stabilization chemistries are protected by issued and pending patents in numerous countries around the world.

    Full terms and conditions for all DNA Genotek products are available here.

    Inside DNA Genotek

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    Phone

    +1 (613) 723-5757

    Email

    info@dnagenotek.com

    Address

    3000 - 500 Palladium Drive
    Ottawa, Ontario, Canada
    K2V 1C2

    DNA Genotek Inc., a subsidiary of OraSure Technologies, Inc. (NASDAQ: OSUR), focuses on providing high-quality biological sample collection products and end-to-end services for human genomics, microbiome and infectious disease applications. The Company's Oragene•Dx and ORAcollect•Dx product lines are the first and only FDA 510(k) cleared saliva-based DNA collection devices for in vitro diagnostic use. DNA Genotek also offers Research Use Only products to collect and preserve large amounts of DNA or RNA from multiple sample types. DNA Genotek markets its products worldwide and has a global customer base with thousands of customers in over 100 countries.

    © 2022 DNA Genotek Inc., a subsidiary of OraSure Technologies, Inc., all rights reserved.

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