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 reader for a lateral flow test device includes a tray or drawer, extendable from the reader, which receives the test device. The tray includes a calibration test pattern affixed or printed thereon placed proximate to the test device and in alignment with the axis of the test device. As the tray is closed and the test device is inserted to the reader, the calibration test pattern is first read by an optics unit including a photodiode. The resulting photodiode output provides a calibration curve S that the reader then uses to correct for any non-linear response of the reader's optical or electronic systems, thus insuring that every reader will yield the same readout for a given test cartridge, despite reader-to-reader variations or reader degradation with time. One use of the reader is for detection of SARS-CoV-2 infection.

Medical test cards for detecting analytes are provided including a substantially planar body, an analyte detection means, an opening feature, and an optical code. The analyte detection means is enclosed within the planar body and is configured to provide a colorimetric change when a portion of the analyte detection means is contacted with the analyte. The opening feature is configured to provide access to the analyte detection means and the optical code includes information identifying the analyte detection means. Uses of such medical test cards include accessing the analyte detection means enclosed within the planar body by using the opening feature and contacting the analyte detection means with the sample. The optical code is read using an imaging device to identify the analyte detection means and the analyte detection means is imaged following contact with the sample using the imaging device.

A reagent test paddle includes a contamination detection medium, a reference color bar, at least one chemical test medium, and a unique identifier. The contamination detection medium includes a reagent that changes color in the presence or when exposed to a hostile or inhospitable environment. Each chemical test medium includes a regent that is responsive to a respective analyte in a biological sample. The reference color bar includes reference color samples of different colors. The unique identifier, like a serial number, identifies the particular paddle and its chemical test medium so it can be uniquely and anonymously associated with a user. A method includes capturing and interpreting digital images of a biologically unexposed and subsequently exposed reagent test paddle at various delay times within an automatically calibrated environment; locating the paddle in a plurality of digital images, extracting the reference color bar and locating the contamination detection medium and chemical test medium in each digital image. Color changes of the chemical test medium and contamination medium are detected at various delay times after sample exposure. To determine validity of test results, the method further compares the detected colors of the contamination detection medium with predetermined colors expected for no contamination and contamination.

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.

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 portable rapid diagnostic test reader system includes a mobile phone having a camera and one or more processors contained within the mobile phone and a modular housing configured to mount to the mobile phone. The modular housing including a receptacle configured to receive a sample tray holding a rapid diagnostic test. At least one illumination source is disposed in the modular housing and located on one side of the rapid diagnostic test. An optical demagnifier is disposed in the modular housing interposed between the rapid diagnostic test and the mobile phone camera.

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.

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.

An apparatus and method, the apparatus comprising: an information electrode; a ground electrode; a photo-resistive element configured to enable the information electrode to be connected to the ground electrode; and wherein the apparatus is configured to enable a sensor element to be positioned overlaying the photo-resistive element such that a change in optical properties of the sensor element controls the connection between the ground and information electrodes.