A miniaturized, self-contained, single-use, disposable assay device for the quantitative determination of the bone resorption marker, NTx, in urine.

We have developed an enabling technology called MODM® (Micro-Optical Detection Method) that has potentially broad diagnostic application in laboratory systems and in rapid testing at the point of care. Inexpensive, single-use diagnostic devices for rapid testing have until now been largely limited to qualitative or semiquantitative tests that require visual interpretation. One unique application of MODM technology, the DRx™ platform, resolves these issues and provides quantitative results at the point of care. It does so by incorporating microelectronics, optics, and dry reagent chemistry within a self-contained, integrated, single-use device. Up to four test results, which may be combinations of general chemistry tests and/or immunoassays (including ratioed results), can be displayed in numeric form on the device’s liquid crystal display within 5 min after sample application. Having no switches or buttons, the device self-activates on addition of the sample. The overall dimensions of the device are 6.4 cm × 5.0 cm × 1.5 cm. An exploded view of the components of DRx is shown in Fig. 1⇓ . The first test developed for this new platform, DRx NTx, contains a dry reagent lateral flow immunoassay strip for measurement of NTx, plus a dry reagent general chemistry …