Originally Published IVD Technology April 2002
Watching the detection
The
average layperson who encounters an IVD rarely has to think much about how the
product works. To such users, the test result is displayed simply and effectively
as a colored line or an LCD readout—and that's all there is to it.
However, the seeming simplicity of such devices conceals some very sophisticated operations that ultimately create a detectable test result. And detection itself is a big deal. According to one estimate, there are about 17 different detection technologies in common use among today's generation of IVD products.
While that number may seem large as an estimate of the commonly used technologies, it almost certainly underestimates the real number of detection technologies under investigation by IVD product developers. For instance, it probably doesn't account for the varieties of miniaturized detection methods that are being explored for use with nucleic acid arrays and microfluidic lab-on-a-chip technologies, or for the hybrid systems that combine the detecting powers of gas (or liquid) chromatography and mass spectroscopy for use in proteomics research.
Many such detection technologies are already in use in laboratory research settings—both in academia and in industry. Some believe that most of these sophisticated techniques will always remain essentially what they are today: tools for researchers. According to this view, such technologies are too cumbersome, too expensive, too labor-intensive, too something, ever to be viable as components in a finished IVD device.
Admittedly, such a view may be correct for some detection technologies. But overall it gives far too little credit to the ingenuity of industry and those who develop instrumented IVD systems. The past decade is, in fact, filled with examples of technologies once thought too something for IVD applications, but are now in everyday use. Systems once thought too complex have been simplified and automated; those thought too expensive are produced cost-effectively; those too labor-intensive are now CLIA-waived.
Accomplishing all of this requires IVD product developers to be constantly on the lookout for new technologies such as those described in this issue's articles on detection technologies ("Paramagnetic-particle detection in lateral-flow assays" and "Taking a fresh look at sensors"). As these articles suggest, the too-something systems in research use today are likely the stock components of tomorrow's IVD products.
Copyright ©2002 IVD Technology
