Originally posted on October 3rd, 2006.
We don't often talk about molecular diagnostics and quality control. Getting a handle on the "usual" tests in chemistry, hematology, etc., has been a tough enough job. But the field of molecular diagnostics is expanding rapidly. And quality for those tests is going to be just as important, if not more important in the future.
Here's a simple description of a quality issue in molecular
diagnostics testing: picture a tube or a well, or in the case of multiplex
testing, several tubes or an array of wells. Each entity contains several
different reactions to determine the presence or absence of specific genetic
sequences. The current practice is to test just one or two of the reactions for
quality control. And even if the QC reaction has different detection probes or
primers than all the others reactions, if the value for the control is
"in", it is assumed that all of the other results are valid.
This has been the state of the art for a limited number of
assays and it seems risky at best. But these array tests are growing by orders
of magnitude. Where now there may be under 100 tests in an array, new ones that
will have several hundred, maybe a thousand, are under development. The
validity of the current state of the art for QC, that is, to rely on testing
just a small sampling of the different reactions, needs to be examined.
Dr. Clark Rundell, from Maine Molecular Diagnostics, is at
the forefront of the QC field for molecular diagnostics. He recently wrote an
article for MLO on the "QC challenges for molecular testing." It's
worth a look - this is going to be one of the key early articles for this
important area.
http://www.mlo-online.com/articles/0506/0506special_feature.pdf
Copyright (symbol) 2006 by Nelson Publishing Inc *www.mlo-online.com
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