A cassette is disclosed that permits, with an instrument, quantitative analysis to be performed at the moment of sample testing without additional steps to the end user. The cassette includes a calibration strip and a sample strip. The calibration strip contains known quantities of analyte, from which a calibration curve can be created and applied to the analysis of the sample strip. The disclosed cassette can utilize light transmission or light reflectance techniques. The cassette may include a separate wash port for rapid washing of a high background sample. The disclosed cassette may perform diagnostic tests for humans, animals, environmental sample, and/or food samples. In some cases, the disclosed devices and techniques may be used to monitor efficacy of drug therapy and patient compliance with respect to physician-prescribed medication in a point of care setting.

Techniques for colorimetric based test strip analysis and reader system are provided. In one aspect, a method of test strip analysis includes: illuminating a test strip wetted with a sample with select spectrums of light, wherein the test strip includes test pads that are configured to change color in the presence of an analyte in the sample; obtaining at least one digital image of the test strip; and analyzing color intensity from the at least one digital image against calibration curves to determine an analyte concentration in the sample with correction for one or more interference substances in the sample that affect the color intensity. A calibration method and a reader device are also provided.

A test strip detecting system includes a test strip, a test strip detecting carrier and a mobile communication apparatus. The test strip detecting carrier includes a container structure, positioning markers and colorimetric calibrating blocks, and the colorimetric calibrating blocks are embedded inside the positioning markers. The test strip is placed in the container structure and reacts with a specimen to generate color blocks. The mobile communication apparatus controls an image capture unit to capture an original image of the test strip placed in the test strip detecting carrier; detects the positioning markers in the original image to obtain a plurality of coordinates of the positioning markers; performs image coordinate calibration according to the plurality of coordinates to generate a calibrated image; and performs a colorimetric calibration for the color blocks and the colorimetric calibrating blocks according to the calibrated image so as to generate a test result.

A test device is configured for diagnostic testing and includes an optical readable medium, in turn including a pattern of spots of material arranged on a surface of the device. Several patterns may be provided. The patterns accordingly formed may be human and/or machine readable. They may notably encode security information, e.g., indicating whether the device has already been used. The spots may notably be inkjet spotted. In addition, a method is provided for decoding information encoded in a pattern of such a test device. In embodiments, liquid is introduced in the device, which comprises additional spots having a substantially different solubility than spots forming the actual pattern. Thus, the additional spots get solubilized in and flushed by the liquid as the latter wets them, and an initially hidden pattern may be read, which is formed of the remaining spots (not solubilized). Encoding methods are also provided.

A cassette is disclosed that permits, with an instrument, quantitative analysis to be performed at the moment of sample testing without additional steps to the end user. The cassette includes a calibration strip and a sample strip. The calibration strip contains known quantities of analyte, from which a calibration curve can be created and applied to the analysis of the sample strip. The disclosed cassette can utilize light transmission or light reflectance techniques. The cassette may include a separate wash port for rapid washing of a high background sample. The disclosed cassette may perform diagnostic tests for humans, animals, environmental sample, and/or food samples. In some cases, the disclosed devices and techniques may be used to monitor efficacy of drug therapy and patient compliance with respect to physician-prescribed medication in a point of care setting.

A device for determining an assay result may include a test strip, a light source system, a light detection system, and a processor.

There is provided a test method for analysing a body fluid in which a test tape is used in a test device to successively provide analytical test fields stored on the test tape, wherein body fluid is applied by a user to the test field provided at a time and the said test field is photometrically scanned using a measuring unit of the device to record measurement signals. To increase the measurement reliability, it is proposed that a control value is determined from a time-dependent and/or wavelength-dependent change in the measurement signals and that the measurement signals are processed as valid or discarded as erroneous depending on the control value.

Systems and methods for producing a calibration standard for an optical analysis system (e.g., a diagnostic reader) from a live test sample are disclosed. The calibration standard may include an image reproduced on a substrate. The reproduced image may be a replication of a digital image of a live test sample captured using the optical analysis system and then digitally processed to be reproduced on the substrate. The image reproduced on the substrate may include at least one optical feature digitally added to the replication of the digital image of the live test sample. The added optical features may be used to allow for more robust calibration using the calibration standard.

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 test device is configured for diagnostic testing and includes an optical readable medium, in turn including a pattern of spots of material arranged on a surface of the device. Several patterns may be provided. The patterns accordingly formed may be human and/or machine readable. They may notably encode security information, e.g., indicating whether the device has already been used. The spots may notably be inkjet spotted. In addition, a method is provided for decoding information encoded in a pattern of such a test device. In embodiments, liquid is introduced in the device, which comprises additional spots having a substantially different solubility than spots forming the actual pattern. Thus, the additional spots get solubilized in and flushed by the liquid as the latter wets them, and an initially hidden pattern may be read, which is formed of the remaining spots (not solubilized). Encoding methods are also provided.