What do hospital labs really need to streamline diagnostic testing: Apple vs. Microsoft environment?

Abstract

Molecular diagnostic (MDx) tests are now commonplace in virtually every hospital and pathology laboratory, however many questions have arisen, such as “What do diagnostic laboratories require from the MDx revolution in order to better improve patient care?†and “Is a fully integrated ‘black-box’ 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 ‘black-box’ 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.  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.  This is in effect the ‘Microsoft’ model, which provides software compatible with existing hardware, compared to the ‘Apple black-box’ model of supplying both the hardware and software.  Clearly there is a place for both approaches in the clinical diagnostic sector, but until the ‘black-box’ 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.  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.  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.