The present invention encompasses a diagnostic test and method to authenticate the veracity of a vaccine. The diagnostic test and method are especially useful in a specific and sensitive immunochromatographic (“ICT”) assay, performable within about 15 minutes, for the authentication, validation, and veracity of a vaccine in a vial prior to administration to a human, such as a COVID-19 vaccine.

The present disclosure relates to a digital microfluidic chemiluminescence detection chip, a detection method and a detection device. The digital microfluidic chemiluminescence detection chip includes a first baseplate and a second baseplate disposed oppositely. A cavity formed by the first and second baseplate includes a mixing and incubating area for combining an antigen, a magnetic particle antibody and an antibody, a luminescence detection area for chemiluminescence and detecting an optical signal, and a communication path for communicating the mixing and incubating area and the luminescence detection area. The first baseplate is provided with a drive array for driving sample solution to move and an optical sensing array for acquiring a luminescence signal of the sample solution. The drive array corresponds to positions of the mixing and incubating area, the luminescence detection area and the communication path. The optical sensing array corresponds to a position of the luminescence detection area.

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.

This invention relates to a method and device for improving the accuracy and performance of detecting or diagnosing sexually transmitted infections (STIs) or STI-causing pathogens. In one embodiment, the present method and device are related to removing one or more interfering molecules such as urea from urine sample, where these interfering molecules alter the performance of Lateral-Flow Immunoassay (LFA). In one embodiment, an aqueous two-phase system (ATPS) embedded entirely within a porous material allows spontaneous phase separation and the target STI-causing pathogens is concentrated in one of the separated phases. In one embodiment, a detection module such as the Lateral-Flow Immunoassay (LFA) is used in connection with other modules so as to detect or diagnose the sexually transmitted infections or the pathogens associated with STIs with an improved performance.

The invention relates to a direct sample collection pad for assay diagnosis of a sample without introducing an additional sampling device into the assay method. This simplifies the system and method of sample collection and assay diagnosis, thus reducing waste and potential for patient irritation or injury during diagnosis.

The present disclosure relates to water dispersible or soluble diagnostic assay methods, devices, kits, and methods of manufacture.

The present disclosure discloses a detection kit and a preparation method thereof and a detection method for novel coronavirus, and relates to the technical field of biomedicine, including an antigen test strip. The antigen test strip includes a substrate, bibulous paper, immune nitrocellulose membrane, and immune microsphere pad. The immune microsphere pad, the immune nitrocellulose membrane and the bibulous paper are pasted on the substrate. The The immune microsphere pad is coated with latex microsphere-labeled novel coronavirus SARS-CoV-2 monoclonal antibody 1. The immune nitrocellulose membrane is provided with a test line coated with novel coronavirus SARS-CoV-2 monoclonal antibody 2 and a quality control line coated with goat anti-mouse IgG polyclonal antibody. The present disclosure uses latex particles as labeled tracer, and uses antigen-antibody reaction and lateral chromatography to detect and analyze targets, having advantages of convenience and swift.

The present disclosure discloses a universal aptamer-based colloidal gold lateral flow test strip for detecting small-molecule substances and belongs to the fields of analytical chemistry, medicine, environment, food safety detection, nano-biosensing and the like. An AuNPs@poly-DNA probe is used for rapidly and sensitively capturing an aptamer, streptavidin sprayed in a test zone and streptavidin-biotin-DNAc sprayed in a control zone do not need to be changed, and another substance can be detected only by changing a nucleic acid chain part of the AuNPs@poly-DNA probe. A universal colloidal gold lateral flow test strip, which is rapid, sensitive and low in cost, has been developed. The test strip method for detecting small-molecule substances is simple, convenient and rapid, and can be used for detection at any time. Only a test solution is needed to be added into a sample port and the test strip is completely developed after 5 min, thus an experiment result can be observed and the detection efficiency can be greatly improved. Qualitative analysis can be conducted by naked eyes, and quantitative analysis can be conducted by a colloidal gold test strip quantitative analyzer.

The present invention provides a device and method based on lateral flow immunoassay for CC16 semi-quantification in serum sample. A novel membrane based semi quantitative detection of physiological/pathological levels of CC16 in the serum has been provided. The device of the present invention provides affordable and easy to use strip-based screening approach for early detection of silicosis using CC16 as a biomarker.

A test strip main body with a sample section, colloidal gold pads, an NC film and a water absorption end in sequence; and the colloidal gold pads are of 3 to 8 layers. Compared with the prior art, the test strip has higher sensitivity, which is beneficial to detection of trace or low-concentration samples.