An analytical process for detecting antibody in human blood serum, which antibody is directed against blood group antigen, wherein the serum contains an additional antibody directed against a surface antigen, by contacting the serum to be analysed with blood cell membranes, which naturally bear surface blood group antigens, followed by detection of agglutination which indicated the presence of antibody directed against at least one surface antigen of the blood cell membranes. The agglutination reaction caused by the additional antibody is prevented, allowing the detection of anti-blood group antibody.

Methods of detecting and flagging and/or suppressing aberrant results caused by incomplete dispersion of an immunoassay reagent used in a turbidimetric immunoassay are disclosed.

The invention includes a method of assaying an analyte in a sample in a portable, handheld microfluidic reader. The method includes the steps of: inserting the sample in the reader; capturing the analyte with a first antibody having a DNA tag attached thereto; capturing the analyte in the sample with a second antibody attached to a surface or having a magnetic nanoparticle (MNP) attached thereto; where a sandwich including the magnetic nanoparticle, first and second antibodies, the analyte and the DNA tag is formed; replicating the DNA tag using isothermal amplification to a predetermined amount of DNA tags detectable by a detector sufficient to overcome the minimal mass sensitivity limitations of the detector; and measuring the amount of replicated DNA tags using the detector. The invention also includes an apparatus or handheld portable field microfluidic reader in which the method is performed.

The invention includes a method of assaying an analyte in a sample in a portable, handheld microfluidic reader. The method includes the steps of: inserting the sample in the reader; capturing the analyte with a first antibody having a DNA tag attached thereto; capturing the analyte in the sample with a second antibody attached to a surface or having a magnetic nanoparticle (MNP) attached thereto; where a sandwich including the magnetic nanoparticle, first and second antibodies, the analyte and the DNA tag is formed; replicating the DNA tag using isothermal amplification to a predetermined amount of DNA tags detectable by a detector sufficient to overcome the minimal mass sensitivity limitations of the detector; and measuring the amount of replicated DNA tags using the detector. The invention also includes an apparatus or handheld portable field microfluidic reader in which the method is performed.

Devices, methods, and kits for detecting at least two analytes present within a small volume single fluid sample obtained from patient for the creation of a multiplexed panel of the various analytes present within the single fluid sample are disclosed.

Devices, methods, and kits for detecting at least two analytes present within a small volume single fluid sample obtained from patient for the creation of a multiplexed panel of the various analytes present within the single fluid sample are disclosed.

Methods for detecting colorectal cancer or precancerous conditions such as adenomatous polyps in a subject by detection of a galactose-containing 40-kDa molecule in a serum sample from the subject are provided. Methods for quantifying the amount of a galactose-containing molecule in a serum sample are also provided. The methods can further comprise assaying the sample for the quantity of at least one additional marker to confirm the detection or diagnosis of colorectal cancer using one or more additional quantitative immune-detection assays; the additional marker can be at least one of galectin-3, a peptide derived from galectin-3, carcinoembryonic antigen (CEA), and CYFRA21-1.

Methods for detecting colorectal cancer or precancerous conditions such as adenomatous polyps in a subject by detection of a galactose-containing 40-kDa molecule in a serum sample from the subject are provided. Methods for quantifying the amount of a galactose-containing molecule in a serum sample are also provided. The methods can further comprise assaying the sample for the quantity of at least one additional marker to confirm the detection or diagnosis of colorectal cancer using one or more additional quantitative immune-detection assays; the additional marker can be at least one of galectin-3, a peptide derived from galectin-3, carcinoembryonic antigen (CEA), and CYFRA21-1.

The invention is directed to a synthetic particle antibody comprising a bi-functional particle framework, such as for example and not limitation, a Janus micro- or nanoparticle, wherein one side of the bi-functional particle comprises targeting ligands (such as for example and not limitation, a protein, a peptide, an aptamer, and/or fragments thereof, wherein the at least one targeting ligand has the ability to specifically bind to a desired cell or tissue type in a subject's body) and the other side of the bi-functional particle comprises immune-activating ligands (such as for example and not limitation, fragments of the Fc portion of antibodies, immune-activating peptides, immune-activating aptamers, and other proteins, peptides or nucleic acids that mimic the structure and/or function of the Fc portion of antibodies).

The invention is directed to a synthetic particle antibody comprising a bi-functional particle framework, such as for example and not limitation, a Janus micro- or nanoparticle, wherein one side of the bi-functional particle comprises targeting ligands (such as for example and not limitation, a protein, a peptide, an aptamer, and/or fragments thereof, wherein the at least one targeting ligand has the ability to specifically bind to a desired cell or tissue type in a subject's body) and the other side of the bi-functional particle comprises immune-activating ligands (such as for example and not limitation, fragments of the Fc portion of antibodies, immune-activating peptides, immune-activating aptamers, and other proteins, peptides or nucleic acids that mimic the structure and/or function of the Fc portion of antibodies).