DNA-Free Certification

Overview

Due to its diverse array of applications, the Polymerase Chain Reaction (PCR) has rapidly become a common tool used in all fields of biotechnology. Everyone from research and academic personnel to forensics and industry professionals use the PCR method daily. Throughout the biotechnology and life science industries the need for lab supplies and products that will not interfere with the PCR process is not only significant, but is quickly increasing as new applications of this test method are constantly being discovered.

By certifying your products with either of our two DNA-Free Certification tests you gain the ability to uphold your product claims with documented product testing that you can make available to your end user in the form of Certificates of Analysis for each lot tested.

Test Method # 1 (Test Sensitivity: 30 pg)

Test samples are extracted and a portion of extract is added to a multiplex PCR reaction containing primers specific for human and mouse genomic DNA. These tubes receive no template DNA so any amplification in these tubes will indicate the presence of contaminating DNA. A negative control reaction is done with DNA-Free water as a reference.

In another set of reactions that test for PCR inhibition, DNA is added to tubes containing the multiplex PCR reaction and product extract. A positive control reaction is performed with DNA-Free water as a reference. Template human and mouse DNA are then added to the product extract and positive control tubes.

After 40 cycles of amplification the reactions are evaluated by agarose gel electrophoresis. The first set of reactions without DNA should produce only primer bands. No DNA should be amplified unless there is either human or mouse DNA contamination. The second set of reactions should produce three bands. One band representing the primers. Two higher molecular weight bands should appear which represent a human DNA band at 270 bp, and a mouse DNA band at 420 bp.

Passing test criteria require no DNA bands in negative reactions and two DNA bands in all positive reactions. Products are tested for the presence of human and mouse DNA contamination using species specific PCR primers*.

Test Method # 2 (Test Sensitivity: 1 pg):

This test is set up similar to Test method # 1, with a few differences appropriate for this test method. Into the positive set of tubes, only human DNA is added. This test goes through 30 amplification cycles and results are evaluated by agarose gel electrophoresis.

The first set of reactions without DNA should should show no DNA amplification. No DNA will be amplified unless there is human DNA contamination. The second set of reactions should produce one band representing the amplification of human DNA at 294 bp.

Passing test criteria are no DNA bands in negative reactions and one DNA band in all positive reactions. Products are tested for the presence of human DNA contamination using species specific PCR primers*.

*Contact our Services Department about DNA-Free Certification testing pertaining to contaminants from different species.

How To Begin Certifying Your Products DNA-Free

To begin certifying your product DNA-Free, a sample of the product must be received by our Services Department to evaluate how best to extract your particular product for testing. Once an extraction procedure is approved in the form of a written Extraction Protocol, it is used each time that product is received for testing.

Each time a new product is submitted for DNA-Free testing, an Extraction Protocol is written and sent to you for approval. Once approved, this protocol is followed whenever this product is submitted. Not all products are the same, thus all products are evaluated on an individual basis. The one-time-only fee for the development of an Extraction Protocol can be waived if you provide MO BIO with your own extraction protocol.

To begin the testing process, Click Here.

You and your company decide upon a testing schedule that best fits the needs of your particular product. MO BIO Laboratories, Inc. can work with you to design a testing schedule that accomplishes this goal. Click here for more information.

Pricing

MB001D	DNA-FREE CERTIFICATION - (TEST METHOD 1, 30 PG SENSITIVITY, HUMAN AND MOUSE)	$295.00
MB001D2	DNA-FREE CERTIFICATION - (TEST METHOD 2, 1 PG SENSITIVITY, HUMAN ONLY)	$324.00
MB001DCP	DNA-Free Certification - Custom Primers (per sample)	INQUIRE
MB070	Extraction Protocol (if applicable)	$236.00

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Download an Excel file to submit your samples for testing by MO BIO.

Click here for instructions