A test strip with selective white blood cell (WBC) lysis for release of WBC contents and the capture and holding of red blood cells (RBC), allowing for fast clearance and result interpretation and more accurate results at early time points due to the lack of red color interference caused by background red heme color of lysing of RBCs. The removal of the red color interference enhances both visual and digital interpretation of test strips, such as test strips of an immunoassay test. The test strip enhances the detection of both intracellular proteins of WBCs and extracellular proteins of RBCs simultaneously such as MxA and CRP, MxA and PCT, MxA and HNL, and MxA and IL-6, MxA and myeloid cells (sTREM-1), MxA and angiopoietin 2, MxA and vascular endothelial growth factor (VEGF) or its soluble vascular endothelial growth factor receptor-1 (sVEGFR1), MxA and heparin binding protein (HBP) or other combinations.

Herein is reported a method for the determination of the amount of a bivalent antibody in a serum or plasma sample obtained from a non-human experimental animal, whereby the antibody comprises one or more mutations in the Fc-region compared to the corresponding wild-type Fc-region that has a sequence of SEQ ID NO: 01, 02, or 03, wherein the method comprises the following steps a) immobilizing a non-antibody polypeptide to which more than one copy of the antigen of the antibody is covalently conjugated on a solid surface, b) incubating the immobilized antigen with the sample to form an immobilized antigen-antibody complex, c) incubating the immobilized antigen-antibody complex with the antigen conjugated to a detectable label to form an immobilized ternary complex, and d) determining the amount of the antibody by determining the amount of the detectable label in the immobilized ternary complex.

Herein is reported a method for the determination of the amount of a bivalent antibody in a serum or plasma sample obtained from a non-human experimental animal, whereby the antibody comprises one or more mutations in the Fc-region compared to the corresponding wild-type Fc-region that has a sequence of SEQ ID NO: 01, 02, or 03, wherein the method comprises the following steps a) immobilizing a non-antibody polypeptide to which more than one copy of the antigen of the antibody is covalently conjugated on a solid surface, b) incubating the immobilized antigen with the sample to form an immobilized antigen-antibody complex, c) incubating the immobilized antigen-antibody complex with the antigen conjugated to a detectable label to form an immobilized ternary complex, and d) determining the amount of the antibody by determining the amount of the detectable label in the immobilized ternary complex.

An object of the present invention is to provide a chromatographic kit and a chromatographic method which have high-sensitivity and in which occurrence of false positives is inhibited. According to the present invention, an immunochromatographic kit is provided, the immunochromatographic kit including: a label substance modified with a first antibody having binding properties with respect to a test substance; a porous carrier having a reaction site holding a second antibody having binding properties with respect to the test substance; an amplification reagent; and a third antibody having an immune host which is the same as that of at least one antibody of the first antibody or the second antibody and not recognizing the test substance.

An object of the present invention is to provide a chromatographic kit and a chromatographic method which have high-sensitivity and in which occurrence of false positives is inhibited. According to the present invention, an immunochromatographic kit is provided, the immunochromatographic kit including: a label substance modified with a first antibody having binding properties with respect to a test substance; a porous carrier having a reaction site holding a second antibody having binding properties with respect to the test substance; an amplification reagent; and a third antibody having an immune host which is the same as that of at least one antibody of the first antibody or the second antibody and not recognizing the test substance.

A method is taught for the accurate determination of the premature rupture of membranes (PROM), defined as spontaneous rupture of membranes before the onset of uterine contractions. More specifically, a lateral flow assay strip tests for at least two antigens to greatly limit or eliminate the possibility of false negatives. A built-in timer in the cassette holding the lateral flow assay further increases the accuracy of the test. A collection buffer vial with self-contained shipping and dropper caps and built-in stand is also taught.

A method is taught for the accurate determination of the premature rupture of membranes (PROM), defined as spontaneous rupture of membranes before the onset of uterine contractions. More specifically, a lateral flow assay strip tests for at least two antigens to greatly limit or eliminate the possibility of false negatives. A built-in timer in the cassette holding the lateral flow assay further increases the accuracy of the test. A collection buffer vial with self-contained shipping and dropper caps and built-in stand is also taught.

This present disclosure provides devices, systems, and methods for performing point-of-care analysis of a target analyte in a biological fluid via a binding assay. The present disclosure includes a cartridge for collecting the target analyte contained in a fluid sample and performing an assay. The cartridge includes an assay stack having a first separation layer, a second separation layer, and a detection membrane. The cartridge also includes a plurality of first complexes comprising a capture molecule and a magnetic bead and a plurality of second complexes comprising a detection molecule and a detection label. Further, the detection membrane includes a substrate that interacts with the detection label to elicit a quantifiable response in the presence of the target analyte. The quantifiable response corresponds to an amount of detection antibody present in the detection membrane, and the amount of detection antibody present corresponds to an amount of the target analyte present.

A multiplexed lateral flow assay device includes an impermeable internal reservoir having an opening to receive a sample deposition. A fluid distributor pad is arranged in fluid communication with a lower surface of the internal reservoir and divides a portion of the sample deposition substantially equally among a plurality of flow paths. Lateral flow assays having a plurality of flow lines are aligned with flow paths of the distributor pad. An impermeable paper top cover has a first window arranged over the opening of the internal reservoir, and at least a second window arranged over the test results of the lateral flow assays. A housing element houses the reservoir, the distributor pad and lateral flow assays. The housing element includes an impermeable bottom cover and a spacer element arranged between the top and bottom covers and, provides a gap between the lateral flow assays and the impermeable paper top cover.

A method for image analysis of medical test results, comprising receiving information from a mobile device application regarding a test performed using a testing device, wherein the testing device includes a plurality of immunoassay test strips and at least one test function indicator on a surface thereof, wherein the mobile device application is configured to recognize the at least one test function indicator to trigger performance of one or more of the plurality of medical test functions, receiving at the server an image of the testing device from the mobile device application, determining by the server RGB values for a plurality of pixels of the image, normalizing by the server the RGB values into a single value, comparing the single value to a control value, and providing by the server a risk indicator, wherein the risk indicator indicates a likelihood of a presence of a medical condition.