Molecular diagnostic (MDx) tests are now commonplace in virtually every hospital and pathology laboratory, however many questions have arisen, such as â€œWhat do diagnostic laboratories require from the MDx revolution in order to better improve patient care?â€ and â€œIs a fully integrated â€˜black-boxâ€™ device the answer to simple rapid diagnostic testing or do mainstream laboratories require more in terms of available testing menu and streamlined workflow?â€Â With more and more â€˜black-boxâ€™ devices available on the market, laboratories need to first decide if they need to make such an investment, and if so, in which to make the most appropriate investment, whilst also considering the cost of consumables.Â Currently the associated costs of an integrated solution can be prohibitive for small to medium sized laboratories, however this does not necessarily mean that they need to miss out on the many benefits that MDx testing can bring. Here we examine what role an open-platform suite of MDx assays can play in the MDx testing landscape. In order to be successful we assume that open-platform tests will utilise a universal sample preparation method for all sample types and be compatible with a broad range of existing Real-Time PCR hardware. Â This is in effect the â€˜Microsoftâ€™ model, which provides software compatible with existing hardware, compared to the â€˜Apple black-boxâ€™ model of supplying both the hardware and software.Â Clearly there is a place for both approaches in the clinical diagnostic sector, but until the â€˜black-boxâ€™ systems broaden their testing menu for all sample types and reduce the cost of consumables, their use may be limited to single analyte niche testing rather than being a central workhorse in the mainstream hospital and pathology laboratories. The goal for testing laboratories is to provide rapid and definitive identification of pathogens in order to aid optimal patient management.Â In the current setting this is only available by using a battery of tests from different manufacturers, or by relying on traditional methods that can take several days to generate a result.Â It is proposed that a true open-platform MDx testing system may bring the benefits of rapid and accurate testing to many small to medium laboratories without the need for a large upfront investment and associated high consumable costs.
Multicolor combinatorial probe coding for real-time PCR. (2011) Huang Q, Zheng L, Zhu Y, Zhang J, Wen H, Huang J, Niu J, Zhao X, Li Q. PLoS One. 2011 Jan 14;6(1):e16033.
Unless specified by prior arrangement, the author agrees to the following terms and assurances:
- For myself and on behalf of the other authors listed on this work, I assign to thinkBiotech LLC the copyright* in the contribution for the full term throughout the world.
- I/we further give to the following assurances
- I am the sole author of the contribution, or, if not, I have the written authority of the other authors to transfer the copyright* to thinkBiotech LLC and give these warranties;
- I and (where appropriate) the other authors are entitled to transfer the copyright to thinkBiotech LLC and no one else would be entitled to prevent us from publishing the contribution;
- To the best of my/our knowledge, all the facts in the contribution are true and accurate;
- The content of the contribution is entirely original to me (and where appropriate to the other authors) or, if not, the written permission of the owner of the copyright in any material copied from elsewhere has been obtained for all media (all such permissions to be attached to the contribution as supplementary files);
- Nothing in the contribution is obscene or libellous;
- Nothing in the contribution infringes any duty of confidentiality which I/or the other authors may owe to anyone else.
- I and/or the other authors have obtained the appropriate clearances from my/our employer(s) or other concerned institution(s).