Fast, quantitative diagnostic reader offers potential for thousands of medical tests.
This medical reader can perform diagnostic tests on any bodily fluid that attenuates light, such as blood, urine, sputum, or other fluid.
Thousands of potential tests are possible, including immunoassay, colorimetric/chromogenic tests, HbA1c, cholesterol, HCG, osteoporosis calcium levels, and many more.
While most physicians have easy access to lab tests, those tests can be slow and expensive. Consumer versions of tests are inaccurate and have limited scope, and often involve sending a sample to a lab.
Physicians, PAs, Emergency Rooms, EMTs, patients, visiting nurses, and caregivers may all need access to quick, accurate tests without waiting for results and making call-backs. Some chronic tests (such as HbA1c for diabetics) require the mixing of reagents, and so are difficult to do at home.
This all-in-one diagnostic reader can handle such tests and report results in as few as ten minutes.
The prototype performs three identical tests on a single whole-blood sample for accuracy; but a greater number of simultaneous tests could be performed, or a battery of tests could be performed on the same sample.
Programming and circuit board design determines the tests that an individual unit performs. All sample handling takes place inside the device.
Prototypes indicate that the device will be inexpensive to build. A unique lancet draws blood for the prototype system.
It slices the skin and creates a pressure differential to avoid injuring the red blood cells by “milking” (typical of finger sticks).
In the prototype, one-button activation isolates a specific region of the Pre-Analytic System, transfers the plasma sample to the main test strip, applies diluents to it, and activates the electronic test protocol. Different activities could be designed into the unit for different tests.
Lab-scale production of fully functional injection-moulded devices has been undertaken for proof-of-concept, but Kimberly-Clark does not envision that the current apparatus is the final product.
- Low-cost to manufacture; low-cost per test.
- Performs any test or assay on any bodily fluid that attenuates light. Thousands of different assays could be designed into the system.
- No sample preparation required. Test strips are consumables.
- All-in-one unit. The system obtains the sample (prototype uses a special lancet to draw blood), meters out the necessary sample volume, transfers that volume to the sample area, and quantifies up to three different tests. Kimberly-Clark believes that this system is the lowest cost approach to performing all these tasks in a single unit.
- Intended for use with an OLED (organic LED) display. OLEDs are bright. The display requires no additional back-lighting. It offers the opportunity for scrolling, text, graphics, and full color more variety and more information than the fixed-position text and images on an LCD display.
- A special lancet was developed for the device that does not damage red cells to be used in testing. Analytes other than blood may require a different sample acquisition system.
Lab scale, injection-molded apparatuses can be made available to interested parties. Kimberly-Clark does not envision the current apparatus to be the final product; however, it is fully functional. Technical reports have been completed, along with market data. Some physician studies have been completed.
This technology is supported by 20 US patents. The most recent year of issue is 2008.