Problem – Misdiagnosis or lengthy delay in test results can make an illness worse or even fatal. The expense of health care continues to increase, including the cost of lab test operations and results analysis. Many lab test can only identify a single microbe type or a limited family of microbe types. So a true identification may take a number of tests to make a correct identification. Standard lab tests can take anywhere from 5 minutes to hours or even days, if incubation is required.

Innovation – The innovation is to take a fluid sample from a patient (blood, saliva, urine, sweat, or even tears) and process it on a microfluidic chip in ~20 minutes, testing for thousands of microorganisms at one time. A few micro liters of a sample is placed in the sample well. The chip is then placed in a desktop or handheld processor and started. The processor applies slight pressure differentials at different wells on the chip in order to perform the tests. The sample is moved into the microfluidic channels and mixed with lysing solution to open the shells on the microbes. The inner materials of the cells (including the cell’s RNA) is flowed across a separation bed which collects the RNA and allows the other materials to pass into a waste well. The RNA bed is washed then an elution solution flows over the bed releasing the RNA in a concentrated slug. This RNA slug is mixed with a SNIP solution to cut the RNA into planned segments and mixed with PCR solution with a tag. The mixture passes through the PCR section which heats and cools the RNA causing the RNA to split and reform doubling the number of RNA segments with each cycle. Tag material will be incorporated into the RNA. The fluid next passes over another bead bed to collect the processed material. The bed is washed and then elusion solution frees the modified RNA onto a micro-array. The micro-array has thousands of different receptor spots printed in a specific matrix. When the RNA comes in contact with a compatible receptor it will become attached. The micro-array is washed to clear any stray material. The processing unit then illuminates the micro-array and optically looks for glowing spot(s) and compares the glowing spots in the array with a database to determine the identified microorganism. The processing unit finally provides a readout to the unit operator.

Manufacturability – Fabrication of microfluidic chips use a similar process used to fabricate electrical circuit boards. Microbeads are inserted into the chip via the nearest well. Biological micro-arrays are commercially printed and can be printed directly in the designated location. The processing unit is comparable to other lab electro/mechanical units.
Marketability – This microfluidic chip process can be used in any hospital, doctor’s office, or in the field with minor training. This process save pain/discomfort and millions of dollars in medical insurance charges making it possible identifying the offending microorganism so the correct cure can be applied.