A handheld diagnostic test device includes a port to removably receive a test cartridge, an element connected with an electronic device, and sensors for detection of test data from a biological or environment sample after reaction with reagents onboard the cartridge. The test device also includes memory storing algorithms for upload to the electronic device to enable a processor thereof: to await elapse of a pre-determined time following reaction of the sample with the reagents; to thereafter instruct the sensors to detect the test data; to generate presentation data based on the test data; and to present the presentation data from a presentation element of the electronic device to a user. A related method includes a connecting step, an uploading step, a presentation step, a cartridge inserting step, a waiting step, a sensing step, and an electronic device processing step.

A method for test strip recognition and interpretation is provided. The method includes the following steps. A plurality of test strips are provided, wherein the test strips are configured to examine a plurality of physiologic parameters respectively, and the test strips respectively have a plurality of color characteristics corresponding to the physiologic parameters respectively. A plurality of physiologic parameter examinations are performed to the corresponding test strips respectively, so as to obtain a plurality of test reactions. An image of the test strips is captured. The color characteristics and the test reactions of the test strips are obtained according to the image. The physiologic parameters examined by the test strips respectively are obtained according to the color characteristics. The physiologic parameters examined by the test strips are matched with the test reactions to obtain a plurality of physiologic parameter examination results.

The present invention generally relates to a wearable electronic device that collects information about test sample using an optical sensor. The wearable device photographs and analyzes one or more organic samples placed on one or more immunoassay regions of a test strip in order to reveal information about the sample. The wearable electronic device may also sequentially photograph a plurality of individual organic samples applied to different immunoassay regions of a test strip.

Electronic test devices and methods include data transfer capabilities. In one implementation, an assay device includes wireless communication capabilities to send assay result decisions and/or values to a separate processing and display device such as a smartphone. In another implementation, light sources are modulated both for performing an assay and encoding and transmitting a result of an assay.

In one embodiment, a diagnostic system for biological samples is disclosed. The diagnostic system includes a diagnostic instrument, and a portable electronic device. The diagnostic instrument has a reference color bar and a plurality of chemical test pads to receive a biological sample. The portable electronic device includes a digital camera to capture a digital image of the diagnostic instrument in uncontrolled lightning environments, a sensor to capture illuminance of a surface of the diagnostic instrument, a processor coupled to the digital camera and sensor to receive the digital image and the illuminance, and a storage device coupled to the processor. The storage device stores instructions for execution by the processor to process the digital image and the illuminance, to normalize colors of the plurality of chemical test pads and determine diagnostic test results in response to quantification of color changes in the chemical test pads.

A method of determining concentration of an analyte in a body fluid uses a mobile device having a camera and an ambient light detector. The ambient light detector has an ambient light sensor and/or an additional camera. An ambient light check is performed. In the ambient light check, ambient light is used to determine an item of ambient light information. If a validity criterion is determined to be met, the concentration of the analyte is determined by evaluating an image of at least a part of a reagent test region of an optical test strip having a sample of body fluid applied thereto. The image is captured by the camera. A mobile device, a kit, a computer program and a computer-readable storage medium are also disclosed.

An assembly for use in a medical diagnostic device and system for analysis of one or more samples is disclosed. In one aspect of the invention, the assembly includes at least one extendable sample tray configured to hold the one or more samples. Additionally, the assembly includes at lease one holding unit coupled to the at least one extendable sample tray, wherein the holding unit is configured to hold a calibration marker. Furthermore, the extendable sample tray and the holding unit are arranged in the same plane and when the extendable sample tray is extended, the at least one holding unit is brought in a field of view of an image capturing unit.

Disclosed herein are devices, systems, methods and kits for performing immunoassay tests on a sample. The immunoassay devices may be used in conjunction with diagnostic reader systems for obtaining a sensitive read-out of the immunoassay results. The immunoassay devices may be especially suited for the detection of at least a first analyte and a second analyte in a sample. The immunoassay devices and methods may utilize a competitive binding-like assay and a sandwich binding assay to detect analytes in a sample.

Sensitive detection of IgG antibodies against SARS-CoV-2 is important to assessing immune responses to viral infection or vaccination and immunity duration. Antibody assays using non-invasive body fluids such as saliva could facilitate mass testing including young children, elderly and those who resist blood draws, and easily allowing longitudinal testing/monitoring of antibodies over time. Here, we developed a new lateral flow (nLF) assay that sensitively detects SARS-CoV-2 IgG antibodies in the saliva samples of vaccinated individuals and previous COVID-19 patients. The 25 minutes nLF assay detected anti-spike protein (anti-S1) IgG in saliva samples with 100% specificity and high sensitivity from both vaccinated (99.51% for samples ≥19 days post 1st Pfizer or Moderna mRNA vaccine dose) and infected individuals. Antibodies against nucleocapsid protein (anti-NCP) was detected only in the saliva samples of COVID-19 patients and not in vaccinated samples, allowing facile differentiation of vaccination from infection. Salivary SARS-CoV-2 anti-S1 IgG antibodies correlated with that in matched dried blood spot (DBS) samples measured by a quantitative pGOLD™ lab-test, showing similar evolution trends post vaccination. The new salivary rapid test platform is applicable to non-invasive detection of antibodies against infection and vaccination for a wide range of diseases.

A reagent strip and a reagent analyzer for reading the reagent strip is described. The reagent strip includes a substrate, at least one reagent pad positioned on the substrate, and a photo luminescent phosphor spot positioned at a fixed location on the substrate. The photo luminescent phosphor spot is formulated to exhibit a predetermined addressable attribute.