The invention relates to one or more aptamers isolated against the SARS-CoV-2 spike protein and methods of using the same. Certain embodiments of the invention relate to methods of detecting the presence, absence or amount of SARS-CoV-2 in a sample using the one or more aptamers described herein. In certain embodiments, the invention relates to one or more aptamers that are capable of specifically binding to SARS-CoV-2 proteins, including aptamers that are capable of specifically binding to the S1 subunit (including the receptor binding domain (RBD)) and/or the S2 subunit within their native conformation as part of the SARS-CoV-2 spike protein in its trimeric form or as separate monomers.

Sensitive detection of IgG antibodies against SARS-CoV-2 is important to assessing immune responses to viral infection or vaccination and immunity duration. Antibody assays using non-invasive body fluids such as saliva could facilitate mass testing including young children, elderly and those who resist blood draws, and easily allowing longitudinal testing/monitoring of antibodies over time. Here, we developed a new lateral flow (nLF) assay that sensitively detects SARS-CoV-2 IgG antibodies in the saliva samples of vaccinated individuals and previous COVID-19 patients. The 25 minutes nLF assay detected anti-spike protein (anti-S1) IgG in saliva samples with 100% specificity and high sensitivity from both vaccinated (99.51% for samples ≥19 days post 1st Pfizer or Moderna mRNA vaccine dose) and infected individuals. Antibodies against nucleocapsid protein (anti-NCP) was detected only in the saliva samples of COVID-19 patients and not in vaccinated samples, allowing facile differentiation of vaccination from infection. Salivary SARS-CoV-2 anti-S1 IgG antibodies correlated with that in matched dried blood spot (DBS) samples measured by a quantitative pGOLD™ lab-test, showing similar evolution trends post vaccination. The new salivary rapid test platform is applicable to non-invasive detection of antibodies against infection and vaccination for a wide range of diseases.

There are provided a concentration device for concentrating a sample solution, which makes it possible to obtain a sample solution concentrated solution having a desired concentration fold ratio, a sample solution concentration method using the concentration device, a sample solution concentration method using the sample solution examination method, and an examination kit including the concentration device. The concentration device is a concentration device for concentrating a sample solution which is an aqueous solution containing a high-molecular-weight molecule, the concentration device including a cylinder that accommodates a particulate super absorbent polymer and a piston that is insertable into the cylinder, where the cylinder has, at a bottom part, a liquid holding part for holding a part of the sample solution injected into the cylinder, the super absorbent polymer is accommodated in the cylinder to be in contact with the liquid holding part on the liquid holding part, and the piston includes the tip part having holes smaller than the particle diameter of the super absorbent polymer after water absorption.

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.

Methods, apparatus, systems, and articles of manufacture to make and/or process a diagnostic test device are disclosed. An example apparatus includes a sensor to measure a current between a first electrode and a second electrode of a bioelectrochemical cell coupled to a test zone corresponding to a target analyte on a porous media of a device; a processor to compare the current to a threshold; and when the current is more than the threshold, identify that the target analyte is present in a sample; and an antenna to wirelessly transmit results.

The invention encompasses methods and test strips for detecting the presence of cerebrospinal fluid (CSF) in a biological sample with a lateral flow device which uses lectin conjugates, anti-antigen conjugates, an immobilized serum line, and an immobilized anti-antigen line.

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 portable point of care device (1) for use in testing a biological sample, the device comprising: a sample collection member (4), a test cartridge (2), and a reader (220).

Provided is a lateral flow assay device capable of detecting a traumatic brain injury marker including a sample pad into which a blood sample containing a traumatic brain injury marker is injected, an adsorption pad including a probe which is mixed to the marker when the traumatic brain injury marker moves from the sample pad to form a traumatic brain injury marker complex, and a porous film which fluid-communicates with the adsorption pad and capillary-migrates the traumatic brain injury marker complex from the adsorption pad to a detection line, in which the probe includes a capture antibody consisting of an antibody labeled with a specific binding material specifically binding to the traumatic brain injury marker and a detector antibody consisting of an antibody labeled with a fluorescent material having a relatively long emission lifetime of 1 microsecond or more, and a mixture of at least two different kinds-origin antibodies is used as the antibody labeled with the specific binding material or the fluorescent material.

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.