MMQCI
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    Frequently Asked Questions:
 
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1. What is the stability of the controls?

Unopened: stable through the expiration date printed on each bottle when stored refrigerated (2 – 8C).

Opened: 30 days from the date of opening if opened material is returned to the refrigerator (2 – 8C) shortly after use.

2. Do I need to extract the controls?

Yes.  Our controls are made to mimic genomic samples and are extracted and tested just as if they were patient samples. INTROL control DNA is stabilized in the matrix and released when processed through common extraction methods as if it were a whole blood specimen.  Following extraction, the released DNA can be used in common amplification based molecular assays techniques.

3. Why do I need to monitor my extraction?

It’s surprising what can affect the extraction and therefore the test results.  For example, a cold room can cause some extraction buffers to precipitate and decrease yields. The problem can cause intermittent falsely low viral loads.  Extraction problems can also cause failure to detect low grade infections.  It’s also important to monitor the extraction regularly for genetic tests, because too much or too little DNA can cause incorrect calls, not just failed amplification.

4. How often should I monitor my extraction?

The best approach is to monitor your extraction on a regular basis at least once a week and when extraction kits change (new shipments, not just new lot numbers).  If all your genetic tests are extracted by one method, you could just monitor one of them per week, but monitoring all is ideal because it will help with troubleshooting.  The point is to regularly look at the control data so you can head off problems and prevent failed runs.

5. Can I quantitate the controls?

NO.  The control extract is NOT quantifiable by routine spectrophotometer methods because the target DNA is of very low mass compared to genomic (but similar copy number), and it contains non-human DNA which would confound the measurement of target.

6. What volume of control do I use?

Extract INTROL controls in the same manner as a whole blood clinical specimen.  Use the SAME volume of INTROL that would be used for a patient sample in your lab.  Certain extraction methods may require additional processing of control material, such as dilution prior to analysis.

7. Is the control infectious?

No.  INTROL controls are made of synthetic DNA suspended in a matrix of carrier DNA of non-human species, preservatives, dye and stabilizers.

8. What is the benefit of a control with genotypes?

The genotype format provides the lab experience in interpreting method interferences that occur in some CF assays from neighboring mutations or polymorphisms. Demonstration of the different genotypes is very helpful in assuring correct typing in your lab.

9. Can I freeze the extracts and use at a later date?

Recommended use as stated in the package insert is to extract and test.  The extract can be re-used within a few days (not on the label because MMQCI has not done specific stability studies), but generally is intended to be discarded.  Some labs do freeze the extracts, but they have to validate this in their own lab to be sure the DNA is stable in the freezer.

10. What should I store extracts in?

High grade polypropylene, such as Axygen Maximum Recovery tubes and Sarstedt microtubes, is recommended for all work with DNA.  Lower grade polypropylene tubes can absorb DNA at low concentrations (mass) and of course DNase can contaminate samples.

 


Maine Molecular Quality Controls Inc. | Telephone: 207.885.1072 | Fax: 207.885.1079 | Email
| 17 years of quality commitment

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