In alternative embodiments are provided methods, devices and systems that use clinical data to determine whether bilirubin binding is normal in a newborn infant with hyperbilirubinemia in order to detect in vivo neurologically toxic levels of bilirubin and to determine whether treatment is needed to prevent a bilirubin-induced neurological injury (e.g. encephalopathy). In alternative embodiments, also provided are devices and systems comprising automated micro-fluid handling technologies such as zone fluidics systems to obtain a bilirubin binding panel. In alternative embodiments, also provided are methods for using the bilirubin binding panel to determine if treatments are needed to ameliorate, reverse, or prevent a bilirubin-induced neurological injury (e.g. encephalopathy) in an individual in need thereof such as a newborn with hyperbilirubinemia (jaundice), and for commencing the treatment, if needed.

The present disclosure relates to paper microfluidic devices for use in combination with a viewing box assembly for imaging and rapid identification and quantification of target analytes in a fluid sample that is deposited onto the device such that one or more target analytes in the sample react with one or more diagnostic components on the paper, causing a detectable reaction. The reacted microfluidic device may then be placed inside an opaque viewing box having an internal light source and top panel viewing aperture through which the microfluidic device may be imaged using a mobile electronic device and graphical user-interface for purposes of detecting and quantifying the one or more target analytes. In some embodiments, the microfluidic device includes diagnostic paper and abase. In some embodiments, the microfluidic device includes a filter layer on top of diagnostic paper layer.

The present invention provides hydrophilic bilirubin derivative particles containing a metal, a use thereof, and a preparation method therefor. The bilirubin derivative particles of the present invention form coordinate bonds with various metals, and thus can be used in MR diagnosis, CT diagnosis, photo-acoustic diagnosis, PET diagnosis, or optical diagnosis. The bilirubin derivative particles of the present invention can release an anticancer drug encapsulated therein to the outside by the combination with a platinum-based anticancer drug and the degradation by a stimulation of light/reactive oxygen species, and exhibit anti-inflammatory and anticancer activities, and thus the bilirubin derivative particles of the present invention have a concept of theranostics in which the bilirubin derivative particles can be for therapeutic uses as well as diagnostic uses.

Provided is a method of detecting a biological material, by which quantitative measurement can be performed easily. The method of detecting a biological material in a sample includes: mixing, with the sample, a fusion protein (C) in which a protein (A) capable of binding the biological material and a chemiluminescent protein (B) are fused together and a substrate for the chemiluminescent protein (B); and observing a luminescent signal from the sample, wherein the protein (A) and the protein (B) are linked in such a manner that resonance energy transfer can occur, the protein (A) is either a protein (A1) that can emit fluorescence in a state where the biological material is bound thereto or a protein (A2) capable of binding an autofluorescent molecule as the biological material, and the protein (B) can excite fluorescence or autofluorescence of the protein (A) with its luminescence energy.

A method for measuring bilirubin levels in a subject. The method can include the steps of providing a sample to be measured from the subject, wherein the sample comprises bilirubin bound to albumin; adding a release agent to the sample, the release agent configured to release the bound bilirubin from the albumin; measuring electrochemical data of the sample using an electrochemical cell; and determining a total serum bilirubin concentration of the sample using the electrochemical data. This method is capable of providing a simpler, faster, and more robust measurement when compared to traditional bilirubin assay methods.

Identifying and classifying a liver condition in a subject based on a blood sample obtained from the subject in a system functionally associated with a blood sample analyzer. The system includes an input interface or a transceiver, a processors, a database, and a computer readable storage medium for instructions execution by the processor(s). The storage medium stores instructions to receive information relating to the subject, and instructions to receive measurements of a plurality of serum biomarkers. The storage medium further stores instructions to identify a group to which the subject belongs, and to obtain from the database average or standardized biomarker measurements for the group. The storage medium further stores instructions to apply a neural network algorithm to the received measurements and biographical information, and instructions to identify, based on an output of the neural network algorithm, the presence of a liver condition, and to classify a severity of the liver condition.

A method for determining a non-anticoagulant interferent in a blood-derived sample of a subject, the method comprising a) determining a value of a coagulation time-related parameter in the sample; b) comparing the value of the coagulation time-related parameter determined in a) to a value of the coagulation time-related parameter determined in at least one reference sample; and c) based on the result of comparison step b), determining the non-anticoagulant interferent in a blood-derived sample of a subject. A method for identifying a blood-derived sample having insufficient quality is further disclosed, the method comprising determining non-anticoagulant interferent(s) according to the aforesaid method, and to devices, kits, and uses related thereto.

It is disclosed a method for calibrating an electronic device for measuring the concentration of a biological compound, in particular bilirubin. The method comprises the step a) of performing (10) a plurality of reflectance measurements for each reference strip of a plurality of reference strips (110-1, 110-2, . . . 110-8) having respective predefined concentration values of the biological compound, the step b) of calculating (20), for each reference strip, a respective value of a statistical reflectance indicator as a function of the plurality of reflectance measurements, generating a plurality of values of the statistical reflectance indicator, the step c) of subdividing the plurality of values of the statistical reflectance indicator into at least two subsets (I, II, III), the step d) of interpolating (41) the values of the statistical reflectance indicator of each subset so as to generate an interpolation curve for each subset, the step e) of calculating (43), for each pair of interpolation curves relative to two adjacent subsets (I, II), a reflectance threshold value for which the difference of the reflectance values of the pair of interpolation curves is minimum, the step f) of selecting, for each interpolation curve, a portion delimited at least in part by the respective reflectance threshold values, said portion being associated with the respective plurality of values of the statistical reference indicator, and the step g) of generating (50) a calibration curve of the electronic device by combining the selected portions of the interpolation curves.

A method for measuring bilirubin levels in a subject. The method can include the steps of providing a sample to be measured from the subject, wherein the sample comprises bilirubin bound to albumin; adding a release agent to the sample, the release agent configured to release the bound bilirubin from the albumin; measuring electrochemical data of the sample using an electrochemical cell; and determining a total serum bilirubin concentration of the sample using the electrochemical data. This method is capable of providing a simpler, faster, and more robust measurement when compared to traditional bilirubin assay methods.

A method for measuring bilirubin levels in a subject. The method can include the steps of providing a sample to be measured from the subject, wherein the sample comprises bilirubin bound to albumin; adding a release agent to the sample, the release agent configured to release the bound bilirubin from the albumin; measuring electrochemical data of the sample using an electrochemical cell; and determining a total serum bilirubin concentration of the sample using the electrochemical data. This method is capable of providing a simpler, faster, and more robust measurement when compared to traditional bilirubin assay methods.