Several organizations are currently developing relatively pain-free methods for extracting small quantities of whole blood (< 1 microliter) from patients. Those methods have the potential to transform routine IVD screening and home testing as patient acceptance of frequent testing is likely to be much improved. One of the areas this will be of great benefit is in cardiac tissue injury screening as well as in post-occurrence monitoring. However, there are currently no cardiac marker assays that function with such small sample volumes. MicroPlumbers Microsciences LLC proposes to develop an inexpensive cardiac marker screening and monitoring device that is compatible with recently developed low-pain microvolume blood extraction devices. The device will rely on microminiaturized lateral flow strip technology to provide a platform for sandwich and competitive immunoassays. The method will be demonstrated with commercially available assay chemistry for Troponin I. MicroPlumbers Microsciences has proprietary technology for the integration and miniaturization of lateral flow technology into microfluidic channels. Furthermore, MicroPlumbers has worked for over a year under contract with a company on a microminiaturized glucose sensor that is designed to utilize their demonstrated device for low pain microvolume blood extraction based on electronic lancing. In Phase I, MicroPlumbers Microsciences will attempt to demonstrate the feasibility of miniaturizing a lateral flow assay for Troponin I, specifically to show that a sample of less than one microliter can produce a visible indicator and control line. During Phase II, a beta disposable prototype will be developed that is capable of a semiquantitative cardiac marker assay on 100 nL to 1 microliter of whole blood. Further, low-pain blood extraction and lateral flow technology will be seamlessly integrated in order to minimize the sample volume required, and thus the level of pain associated with its extraction.
