Abstract: The present invention is directed an immunoassay method, which re-uses an antibody-immobilized test probe and reagents for quantitating an analyte in different samples, anywhere from about 3 to 20 times, while maintaining acceptable clinical assay performance. The method regenerates the test probe by dipping the test probe in an acidic solution having pH about 1-4, after the completion of each cycle of reaction. The present invention is also directed to a unitized cartridge (a strip) for an immunoassay test. Each unitized cartridge contains all necessary reagents can be used for 3-20 cycles to measure 3-20 different samples.

Abstract: This invention relates to an apparatus for conducting immunoassay test. The apparatus includes a groove unit having a groove along a vertical direction configured to hold a rod-shaped portion of a probe along the vertical direction, and a push pin configured to move along a horizontal direction, the push pin being capable of residing at a first position and a second position. A tip of the push pin is capable of pressing the rod-shaped portion of the probe against the groove when the push pin resides at the first position. The distance between the tip of the push pin and the groove is larger than a diameter of the rod-shaped portion of the probe when the push pin resides at the second position.

Abstract: The present invention is directed to an assembly for use in detecting an analyte in a sample based on thin-film spectral interference. The assembly comprises a waveguide, a monolithic substrate optically coupled to the waveguide, and a thin-film layer directly bonded to the sensing side of the monolithic substrate. The refractive index of the monolithic substrate is higher than the refractive index of the transparent material of the thin-film layer. A spectral interference between the light reflected into the waveguide from a first reflecting surface and a second reflecting surface varies as analyte molecules in a sample bind to the analyte binding molecules coated on the thin-film layer.

Abstract: The present invention relates to a method for quantitating an analyte having a wide range concentration in a single assay without having to dilute the sample and repeating the assay. The key feature of the invention is having two cycles of events including sample binding to probe, binding reactions, and detection. After the first cycle of binding and detecting, the probe is dipped into the same sample vessel to bind additional analyte in the sample vessel at a condition that is more favorable to binding than the condition in the first cycle.

Abstract: The present invention is directed to a luminescent immunoassay method for detecting an analyte in a liquid sample with high sensitivity. The invention provides a unique combination of (i) using a probe having a small sensing surface area for binding analyte molecules, (ii) using a high molecular weight branched polymer conjugated with multiple binding molecules and multiple luminescent labels, and (iii) cycling the probe having immunocomplex formed back to the reagent vessel and amplification vessel 1-10 times and repeating the reaction with the reagent and the amplification polymer, to improve the sensitivity of detection level. For each cycling, the luminescent signal is increased significantly over the noise. The present invention is also directed to an electrochemiluminescent detection system for measuring a chemiluminescent signal on a probe tip.

Abstract: This invention relates to an apparatus for conducting immunoassay test. The apparatus includes a groove unit having a groove along a vertical direction configured to hold a rod-shaped portion of a probe along the vertical direction, and a push pin configured to move along a horizontal direction, the push pin being capable of residing at a first position and a second position. A tip of the push pin is capable of pressing the rod-shaped portion of the probe against the groove when the push pin resides at the first position. The distance between the tip of the push pin and the groove is larger than a diameter of the rod-shaped portion of the probe when the push pin resides at the second position.

Abstract: The present invention relates to a method for quantitating an analyte having a wide range concentration in a single assay without having to dilute the sample and repeating the assay. The key feature of the invention is having two cycles of events including sample binding to probe, binding reactions, and detection. After the first cycle of binding and detecting, the probe is dipped into the same sample vessel to bind additional analyte in the sample vessel at a condition that is more favorable to binding than the condition in the first cycle.

Abstract: This invention relates to a detection system for measuring a fluorescent signal in a fluorescent assay. The system comprises a probe having a small sensing surface bound with a fluorescent label, and a light source and a detector both mounted at the proximal side of the sensing surface of the substrate. The invention also relates to a method for detecting an analyte in a liquid sample using a probe tip having a small surface area (?5 mm) and a high molecular weight polymer (?1 MD) having multiple binding molecules and multiple fluorescent labels. The binding reaction is accelerated by flowing the reaction solutions laterally and moving the probe tip up and down in the reaction vessels. The invention furthers relates to a fluorescent labeling composition comprising a cross-linked FICOLL® molecule having a plurality of binding molecules and a plurality of fluorescent labels.

Abstract: This invention relates to an apparatus for conducting immunoassay test. The apparatus includes a groove unit having a groove along a vertical direction configured to hold a rod-shaped portion of a probe along the vertical direction, and a push pin configured to move along a horizontal direction, the push pin being capable of residing at a first position and a second position. A tip of the push pin is capable of pressing the rod-shaped portion of the probe against the groove when the push pin resides at the first position. The distance between the tip of the push pin and the groove is larger than a diameter of the rod-shaped portion of the probe when the push pin resides at the second position.

Abstract: The present invention is directed to a luminescent immunoassay method for detecting an analyte in a liquid sample with high sensitivity. The invention provides a unique combination of (i) using a probe having a small sensing surface area for binding analyte molecules, (ii) using a high molecular weight branched polymer conjugated with multiple binding molecules and multiple luminescent labels, and (iii) cycling the probe having immunocomplex formed back to the reagent vessel and amplification vessel 1-10 times and repeating the reaction with the reagent and the amplification polymer, to improve the sensitivity of detection level. For each cycling, the luminescent signal is increased significantly over the noise.

Abstract: This invention relates to a detection system for measuring a fluorescent signal in a fluorescent assay. The system comprises a probe having a small sensing surface bound with a fluorescent label, and a light source and a detector both mounted at the proximal side of the sensing surface of the substrate. The invention also relates to a method for detecting an analyte in a liquid sample using a probe tip having a small surface area (?5 mm) and a high molecular weight polymer (?1 MD) having multiple binding molecules and multiple fluorescent labels. The binding reaction is accelerated by flowing the reaction solutions laterally and moving the probe tip up and down in the reaction vessels. The invention furthers relates to a fluorescent labeling composition comprising a cross-linked FICOLL® molecule having a plurality of binding molecules and a plurality of fluorescent labels.

Abstract: The present invention is directed to a luminescent immunoassay method for detecting an analyte in a liquid sample with high sensitivity. The invention provides a unique combination of (i) using a probe having a small sensing surface area for binding analyte molecules, (ii) using a high molecular weight branched polymer conjugated with multiple binding molecules and multiple luminescent labels, and (iii) cycling the probe having immunocomplex formed back to the reagent vessel and amplification vessel 1-10 times and repeating the reaction with the reagent and the amplification polymer, to improve the sensitivity of detection level. For each cycling, the luminescent signal is increased significantly over the noise.

Abstract: The present invention is directed to an assembly for use in detecting an analyte in a sample based on thin-film spectral interference. The assembly comprises a waveguide, a monolithic substrate optically coupled to the waveguide, and a thin-film layer directly bonded to the sensing side of the monolithic substrate. The refractive index of the monolithic substrate is higher than the refractive index of the transparent material of the thin-film layer. A spectral interference between the light reflected into the waveguide from a first reflecting surface and a second reflecting surface varies as analyte molecules in a sample bind to the analyte binding molecules coated on the thin-film layer.

Abstract: The present invention is directed to an assembly for use in detecting an analyte in a sample based on thin-film spectral interference. The assembly comprises a waveguide, a monolithic substrate optically coupled to the waveguide, and a thin-film layer directly bonded to the sensing side of the monolithic substrate. The refractive index of the monolithic substrate is higher than the refractive index of the transparent material of the thin-film layer. A spectral interference between the light reflected into the waveguide from a first reflecting surface and a second reflecting surface varies as analyte molecules in a sample bind to the analyte binding molecules coated on the thin-film layer.

Abstract: This invention relates to a cartridge for an immunoassay test. The cartridge comprises (a) a probe well comprising a probe and a cap, the cap being in a closed position to enclose the probe in the probe well, wherein the probe has a bottom tip coated with analyte-binding molecules, (b) a sample well to receive a sample, (c) one or more reagent wells, (d) a plurality of wash wells each containing a first aqueous solution, and (e) a measurement well having a light transmissive bottom, the measurement well containing a second aqueous solution, wherein the openings of the sample well, reagent well, measurement well and wash wells are sealed. The present invention also relates to an apparatus for loading and releasing a probe. The apparatus comprises a push pin and a groove to load and transfer the probe to a plurality of locations, such as different wells in the above-mentioned cartridge, to conduct the immunoassay test.

Abstract: This invention relates to a cartridge for an immunoassay test. The cartridge comprises (a) a probe well comprising a probe and a cap, the cap being in a closed position to enclose the probe in the probe well, wherein the probe has a bottom tip coated with analyte-binding molecules; (b) a sample well to receive a sample; (c) one or more reagent wells; (d) a plurality of wash wells each containing a first aqueous solution; and (e) a measurement well having a light transmissive bottom, the measurement well containing a second aqueous solution; wherein the openings of the sample well, reagent well, measurement well and wash wells are sealed. The present invention also relates to an apparatus for loading and releasing a probe. The apparatus comprises a push pin and a groove to load and transfer the probe to a plurality of locations, such as different wells in the above-mentioned cartridge, to conduct the immunoassay test.

Abstract: This invention relates to a detection system for measuring a fluorescent signal in a fluorescent assay. The system comprises a probe having a small sensing surface bound with a fluorescent label, and a light source and a detector both mounted at the proximal side of the sensing surface of the substrate. The invention also relates to a method for detecting an analyte in a liquid sample using a probe tip having a small surface area (?5 mm) and a high molecular weight polymer (?1 MD) having multiple binding molecules and multiple fluorescent labels. The binding reaction is accelerated by flowing the reaction solutions laterally and moving the probe tip up and down in the reaction vessels. The invention furthers relates to a fluorescent labeling composition comprising a cross-linked FICOLL® molecule having a plurality of binding molecules and a plurality of fluorescent labels.

Abstract: The present invention is directed to an assembly for use in detecting an analyte in a sample based on thin-film spectral interference. The assembly comprises a waveguide, a monolithic substrate optically coupled to the waveguide, and a thin-film layer directly bonded to the sensing side of the monolithic substrate. The refractive index of the monolithic substrate is higher than the refractive index of the transparent material of the thin-film layer. A spectral interference between the light reflected into the waveguide from a first reflecting surface and a second reflecting surface varies as analyte molecules in a sample bind to the analyte binding molecules coated on the thin-film layer.

Abstract: The present invention is directed to a luminescent immunoassay method for detecting an analyte in a liquid sample with high sensitivity. The invention provides a unique combination of (i) using a probe having a small sensing surface area for binding analyte molecules, (ii) using a high molecular weight branched polymer conjugated with multiple binding molecules and multiple luminescent labels, and (iii) cycling the probe having immunocomplex formed back to the reagent vessel and amplification vessel 1-10 times and repeating the reaction with the reagent and the amplification polymer, to improve the sensitivity of detection level. For each cycling, the luminescent signal is increased significantly over the noise.

Abstract: The present invention is directed to an assembly for use in detecting an analyte in a sample based on thin-film spectral interference. The assembly comprises a waveguide, a monolithic substrate optically coupled to the waveguide, and a thin-film layer directly bonded to the sensing side of the monolithic substrate. The refractive index of the monolithic substrate is higher than the refractive index of the transparent material of the thin-film layer. A spectral interference between the light reflected into the waveguide from a first reflecting surface and a second reflecting surface varies as analyte molecules in a sample bind to the analyte binding molecules coated on the thin-film layer.