How is the DNA Kit, Oragene?

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Genetic testing is used to distinguish one individual from the other. Earlier criminal cases were difficult to prove. Nowadays, it has become easier to detect a suspect with the help of DNA sampling. DNA samples obtained from the site are matched with the suspect's genetic materials. DNA samples are also required for determining the birth lineage of a person. DNA samples are usually collected from the body fluids (blood, semen, urine or saliva) of an individual. In most cases, saliva sample is considered. Saliva samples is specifically used to obtain high quality genomic DNA which increase the response rate in epidemiologic studies. To collect saliva samples, a device named "Oragene DX" is used. This product has been devised by DNA Genotek. It is the world's leading producer of biological sample collection products for RNA and DNA testing.

Is the Oragene DX approved by FDA?

On 8th December 2011, DNA Genotec, the subsidiary of Orasure technologies Inc., received FDA approval to market the Oragene Dx, DNA collection device. The product was granted 510(k) clearance. It is the first 510(k) approval for a DNA collection and stabilization device. The FDA 510(k) clearance ensures that personalized test providers and clinical diagnostic centers can use Oragene DX kit. Now a patient can choose between Oragene DX and invasive methods for genetic tests. Several molecular diagnostics can easily use Oragene DX to streamline their regulatory submissions. Oragene DX has cleared both eSensor and warfarin sensitivity saliva tests.

What is the specialty of the Oragene Dx?

The Oragene DX, dna kit is an all-in-one system for collection, stabilization and transportation of DNA. Oragene DX kits are being used in more than 100 nations all around the world. Oragene DX is more reliable than traditional DNA sample collection tools like buccal swabs. It is useful for self-collection or assisted collection of samples. Oragene DX is a 100% painless, non-invasive method.

What are the advantages of Oragene DX?

Oragene DX DNA device, can be used for donors who are unable to spit. Collected DNA sample are preserved in bacteriostatic solutions. The samples remain unaffected at room temperature for one year. The bacteriostatic solution prevents degradation of human DNA post sample collection. It reduces transportation and storage costs. During collection and transportation, DNA samples can be exposed to temperatures ranging between -20°C to 50°C. Oragene DX kit is suitable for patients or individuals unable or unwilling to comply with blood collection. Clinical studies have found that Oragene DX sample has lowest bacterial content compared to all oral collection methods.  No phlebotomy is required to purify the sample. 

How to use Oragene DX?

Place and move the sample collection sponge along the gums and inner cheeks. Allow it to absorb as much saliva as possible. Now, insert the sponge in V-notch of the funnel. Wring saliva against the inner wall of the V-notch. Repeat the collection step until the saliva reaches fill-line of the collecting tube. Close the funnel lid tightly until you hear a loud click. Shake the closed tube for 5 seconds.

For more information on DNA, click on the links below:

Use of DNA Fingerprinting in Human Health and Society

Recombinant DNA Technology in the Synthesis of Human Insulin

DNA Technology in Forensic Science

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