Effective format for transport,
storage and processing
-
Superior Samples • Proven Performance
- 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
|
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
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.
View donor user instructions for OCD-100
View donor user instructions for OCD-100A
ORAcollect•Dx versus Buccal swabs
 |
| |
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
Protocols
Videos
Scientific Posters
User Instructions
Safety Data Sheets
…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
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.
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