- Service Description
- Experienced - MO BIO has over 22 years of experience in providing human DNA-free certifications to many major medical device companies and suppliers of plastic consumables
- Qualified - All MO BIO Services technicians receive extensive training and are qualified to test raw materials or end products for the presence of human DNA
The accuracy and validity of sensitive applications such as forensic crime studies and DNA paternity testing require elimination of any potential contaminant, including human DNA, from all lab solutions. Thus, it is critical that samples remain free of extraneous contaminating human DNA at all times.
Certifying products human DNA-free has become a common practice among general laboratory plastics manufacturers as well as medical device and pharmaceutical companies. Testing your product lines for the presence of human DNA will add integrity to your products and will enable a wider range of customers to utilize your products for their experiments and applications.
DNA-free certification testing for DNA from species other than human can also be performed. Please contact MO BIO Services for details.
MO BIO offers two test methods for DNA-Free Certification:
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.
- Contact Services
Our Services team has over 23 years of experience in providing services that keep your products competitive and in demand. Our customers include many of the top plastics and medical device suppliers in the industry. Our services specialists can also work with you to develop a custom testing schedule and/or custom tests that fit the specific needs of your products. We are located in Carlsbad, CA, USA.