Chembio Diagnostic Systems, Inc.

Chembio Diagnostics Systems, Inc.

Javanbakhsh Esfandiari

Konstantin Lyashchenko

Candace McCombs

Angelo H Gunasekera

Test cells with first and second sorbent materials defining a first flow path for a solution, a second flow path distinct from the first flow path for a sample, and a test site with immobilized antigens or antibodies or other ligand-binding molecules located at the junction of the sorbent materials for identifying one or more ligands. In one embodiment, a single highly sensitive immunoassay device is provided that detects the presence in a body fluid sample of two or more COVID-19 (Coronavirus disease 2019) antibodies including immunoglobulin M (IgM) and/or immunoglobulin G (IgG) antibodies to nucleocapsid protein (NP) and spike protein receptor binding domain (RBD), and optionally spike protein S1 subunit (S1) COVID-19 virus antigens. The immunoassay device is sensitive in detecting early infection using IgM antibody detection and continuing infection using IgG antibody detection. Additionally, successful inoculation is distinguished from infection after inoculation by comparing NP and RBD results.

Coronavirus IgG/IgM multiplexed dual path immunoassay device

A kit and a method are disclosed for collecting and preparing a biological sample for testing where the sample is to be mixed with a buffer prior to being tested.

Method and apparatus for collecting and preparing biological samples for testing

Test devices are provided for determining the presence of a first ligand in a sample. In some embodiments depletion conjugates are used to deplete the ligands different from but related to the first ligands from the sample.

Immunoassay utilizing trapping conjugate

Methods are provided for determining the presence of a first ligand in a sample. In some embodiments depletion conjugates are used to deplete the ligands different from but related to the first ligands from the sample. In some embodiments, interim binding agents are used to enhance the test signal.

Immunoassay methods utilizing trapping conjugate

A single-use multiplex, or assay, screening test for the detection of one or more of a plurality of unrelated febrile illnesses is provided. The febrile illnesses for which the test is designed are unrelated, in that the illnesses may be caused, by way of example, by infection from viruses, bacterium and/or parasites; by infection from viruses, bacterium, parasites or other contagions that are animal borne; by infection from viruses, bacterium, parasites, or other contagions that can be aerosolized for transmission; by infection from viruses, bacterium, parasites or other contagions that are transmitted from direct contact; by infection from viruses, bacterium, parasites or other contagions that are generally transmitted in the tropics and/or subtropics; and/or by infection from a virus, bacteria, parasite sharing one or more related feature and which causes a febrile illness. The assay test provides rapid results to a point of care center or other facility requiring such results to facilitate treatment and or containment of the illnesses.

Rapid screening assay for qualitative detection of multiple febrile illnesses

Rapid diagnostic test reader

Test devices are provided for determining the presence of a first ligand in a sample. In some embodiments depletion conjugates are used to deplete the ligands different from but related to the first ligands from the sample. In some embodiments, interim binding agents are used to enhance the test signal.

Systems include test cells with sorbent material in a T-shape and defining a first flow path for a solution and a second flow path for a sample, and a test line or test site with immobilized antigens or antibodies or other ligand binding molecules located at the junction of the T. A housing houses the sorbent material and defines a first hole adjacent an end of the first flow path for receiving the solution and a second hole adjacent an end of the second flow path for receiving the sample.

Dual path immunoassay device

A test device for use with a liquid solution includes a housing that houses a plurality of sorbent strips. At least one strip has a location for receiving the solution. The housing defines at least an opening in said housing wherein said opening is aligned with the location for receiving the solution. The device includes a sealed reservoir filled with the liquid solution, the sealed reservoir being disposed in alignment with the opening and coupled to the housing. The device includes an opener coupled to the housing. The opener is arranged to rotate from a first position, in which the opener is not in contact with the sealed reservoir, to a second position, in which the opener causes the sealed reservoir to effect a release of the solution from the reservoir and into the opening and onto the sorbent strip housed within the housing.

Integrated buffer dual-path immunoassay device

Test cells have a first sorbent strip with a sample receiving location and defining a first migration path, a distinct second sorbent strip which receives buffer solution and at least partially defines a second migration path distinct from and elongated relative to the first migration path, conjugate supported by the second strip, a test site located at a junction of the first and second strips and having an immobilized ligand-binding mechanism, and a divider which directs a first amount of the buffer to the first strip to move the sample to the test site and a second amount to the second strip to move the conjugate to the test site. The first and second migration paths have first and second lengths chosen so that ligand in the sample reaches the test site and binds to the immobilized ligand-binding mechanism prior to the conjugate reaching the test site.

Growing community of inventors

Stony Brook, NY, United States of America

Javanbakhsh Esfandiari