A marker and product for auxiliary diagnosis of valvular heart disease (VHD) is provided. The present disclosure provides for the first time using PLAUR as a biomarker for auxiliary diagnosis of VHD. When the PLAUR is used for auxiliary diagnosis, the diagnostic result can be obtained in only one working day (high detection speed) with sensitivity/accuracy is much higher than the sensitivity/accuracy of NT-ProBNP and hsCRP, and a high-throughput operation is enabled.

A test strip assembly 101 for dipping in a bodily fluid sample to analyse a presence or absence of one or more analytes is provided. The test strip assembly 101 includes a basal layer (1), a first adhesive layer (2) that is entirely present over the basal layer (1) a porous membrane (3) that is present over the first adhesive layer (2) and the bodily fluid flows in a lateral direction in the porous membrane (3); a second adhesive layer (4); and a number of detection labels (5) placed on the porous membrane through the adhesive layer (4) and receives bodily fluids flowing in the lateral direction in the porous membrane such that the bodily fluids then flow in a vertical direction in the detection labels (5). A device including the test strip assembly (101) is provided.

An immunological test method includes a concentration step of mixing a solution capable of containing an antigen, a superabsorbent polymer, and a labeled antibody against the antigen, to obtain a concentrated and mixed solution which is a concentrated mixed solution containing composite bodies of the antigen and the labeled antibody and a detection step of detecting the composite bodies in the concentrated and mixed solution using an antigen-antibody reaction, in which a swelling ratio of the superabsorbent polymer is more than 0.2 g/g and less than 800 g/g.

A rapid immunoassay method and apparatus for detecting foot and mouth disease virus are disclosed. The method and test device permit pen-side testing of animals and provide test results within a relatively short time period. In a preferred embodiment, the method and apparatus provide a means for differentiating between FMDV-infected and FMDV-vaccinated animals.

The present invention discloses a time-resolved immunoquantitation test strip for detecting tetrodotoxin (TTX) in shellfish food, which belongs to the technical field of rapid detection of time-resolved immunoassay. In the present invention, fluorescent microspheres are adopted to replace the traditional colloidal gold; the fluorescent microsphere is used for labeling a TTX antibody complex; by utilizing a competitive immunization method, the fluorescent microsphere, serving as a fluorescent probe, is used for immunochromatography; and by reading the fluorescence value of a detection line on a fluoroimmunoassay instrument, the TTX in shellfish samples can be analyzed quantitatively and rapidly. The time-resolved immunoquantitation test strip of the present invention can be used for detecting the content of the TTX in various types of shellfish food quantitatively and rapidly and is strong in specificity and high in sensitivity, wherein when the concentration of the TTX is 0.5-40 ng/mL, the logarithmic value of the concentration has a linear relationship with T/To, a linear equation is: Y=0.57365-0.2668LgX, R.sup.2=0.9940, and the limit of detection can reach 0.047 ng/mL.

A diagnostic device (1) for detecting a first member of a reporter-analyte pair. The diagnostic device comprises an inlet for receiving a liquid, biological sample and a porous membrane element (10) comprising a detection portion. The detection portion is in liquid communication with the inlet and a second member of the reporter-analyte pair is immobilised on the detection portion. One of the first or second member of the reporter-analyte pair comprises a biological antigen and the other of the first or second member of the reporter-analyte pair comprises an antibody specific for the biological antigen. The biological antigen comprises a spike protein, or a fragment thereof, of COVID-19. The device is for independent detection of the spike protein, or the fragment thereof, or of an antibody specific for the spike protein, or the fragment thereof, in the biological sample.

Provided are a composition for detecting SARS coronavirus 2, a composition for diagnosing SARS coronavirus 2 infection, a method for detecting SARS coronavirus 2, and a SARS coronavirus 2 infection diagnostic kit, wherein a receptor and an antibody that binds to SARS coronavirus 2 spike protein are used in order to detect SARS coronavirus 2 (SARS-CoV-2) or diagnose SARS coronavirus 2 infection (COVID-19).

Provided herein are devices and methods for monitoring biofluids related to ovulation. Such devices include the use of electrochemical aptamer-based (EAB) sensors.

Provided are a diagnostic system and methods for detecting the presence or absence of one or more targets that represent virus infection, inflammatory diseases and/or respiratory disorders by optically and noninvasively observing changing in color of the diagnostic system upon binding of the antigen of interest. Exemplary diagnostic systems and methods include detection of SARS-CoV-2 virus S protein or receptor of advanced glycation end products (RAGE) for diagnosis of COVID-19 infection or inflammatory/respiratory diseases.

The present invention relates to lateral flow assay devices adapted to detect IgA specific for SARS-CoV-2 in biological samples from subjects suspected to have COVID-19, and methods of using the lateral flow assay devices.