Devices, systems, and methods for measuring biomarkers in biological fluids

#Embodiments are related generally to measuring biomarkers in biological fluids, and more specifically to determining a concentration of creatinine in blood, plasma, or serum using a test strip and a portable optical sensing device paired to a mobile device.

#Certain individuals require regular monitoring of analyte concentrations to aid in diagnosis and/or treatment of certain conditions such as, but not limited to, diabetes. For example, in diabetic monitoring applications, portable reader devices and corresponding test strip kits are commonly used by diabetic individuals or their physicians to detect high or low blood glucose levels. The monitored levels of glucose can aid in treatment and management of diabetes by notifying a user of abnormal levels, which allows the user to make necessary adjustments such as increasing sugar or insulin intake to stabilize blood glucose levels.

#One such portable reader device for monitoring conditions, including diabetes, is commercially available as the Aina Device, available from the applicant of the present disclosure, which is described in U.S. Pat. No. 10,436,773 (application Ser. No. 14/997,749), entitled “Mobile Device Based Multi-Analyze Testing Analyzer for Use in Medical Diagnostic Monitoring and Screening,” and at http://www.janacare.com/technology.html, all of which are incorporated herein by reference in their entireties. The portable reader device is connectable to a portable analyzer device, such as a smart phone, that has installed thereon algorithms for analyzing the reader device output, and quantifying the analyte concentration based on the reader device output.

#Subject matter hereof may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying figures, in which:

#FIG. 1A is an exploded perspective view of a test strip assembly according to an embodiment.

#FIG. 1B is an exploded cross-sectional view of the test strip assembly of FIG. 1A.

#While various embodiments are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the claimed inventions to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter as defined by the claims.

#The embodiments described below are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the following detailed description. Rather the embodiments are chosen and described so that others skilled in the art may appreciate and understand the entire disclosure.

#Referring to FIGS. 1A, 1B, 2A, and 2B, a biosensor device, or biosensor, comprises a composite test strip assembly 100 used for applying a sample and for inserting strip assembly 100 into an optical sensing device, such as an optoelectronic reader, either coupled to containing an analyzer device, for analysis of the sample. In embodiments, the sample is applied to test strip assembly 100 after insertion into the optical sensing device, while in other embodiments, the sample is applied to test strip assembly 100 before insertion into the optical sensing device.