Described herein are systems and methods for extending the dynamic range of assay methods and systems used for determining the concentration of analyte molecules or particles in a fluid sample. In some embodiments, a method comprises spatially segregating a plurality of analyte molecules in a fluid sample into a plurality of locations. At least a portion of the locations may be addressed to determine the percentage of said locations containing at least one analyte molecule. Based at least in part on the percentage, a measure of the concentration of analyte molecules in the fluid sample may be determined using an analog, intensity-based detection/analysis method/system and/or a digital detection/analysis method/system. In some cases, the assay may comprise the use of a plurality of capture objects.

The present invention relates to body fluid monitoring. It is proposed to incorporate a reagent-free calibration method into a patch or wearable. The method comprises capturing molecules of interest, i.e. calibration molecules inside the bioliquid of the patient, and release them when needed for calibration. This eliminates the need for onboard reagent storage. Because the calibration is done in the same bioliquid, any matrix effects are corrected for.

A repeatable method for detecting circulating tumor cells in vitro is provided. The method involves combining a test sample from a patient suspected of having circulating tumor cells, and a non-lytic adenoviral system, and culture media for the cells. The adenoviral system utilizes (i) a first replication-defective adenoviral particle in which an expression cassette is packaged, said expression cassette comprising an adenoviral 5′ and 3′ ITRs and a tumor-specific promoter; and (ii) a coding sequence for a reporter protein which is expressed in the presence of circulating tumor cells, and an adenoviral 3′ ITR. The test sample and the non-lytic adenoviral system are incubated for a sufficient time to permit expression of the reporter protein, and measuring reporter protein expression in the test samples, whereby presence of reporter expression indicates the presence of circulating tumor cells in the sample.

Analytical assay reaction cartridges, kits containing same, and methods of production and use thereof are disclosed. These cartridges include a magnetic assembly that surrounds at least a portion of a sample read window on the cartridge. The cartridge also includes an analytical reagent positioned therewithin, wherein the analytical reagent comprises magnetic beads coated with at least one anti-red blood cell antibody.

A target analysis tool and a target analysis method that allow easily analysis of a target. The first target analysis tool includes: a first chamber; a second chamber; and a third chamber. The first chamber, the second chamber, and the third chamber are disposed continuously in this order. The first chamber contains, as a first reagent, an immobilized first binding substance obtained by immobilizing, on a carrier, a first binding substance that binds to a target. The second chamber contains, as a second reagent, a labeled second binding substance obtained by binding a labeling substance to a second binding substance that binds to the first binding substance. The third chamber is a detection section in which the labeled second binding substance is detected.

A biomaterial collection device can include a wire that includes a functional member including a proximal end, a distal end, a first flat surface and a second flat surface opposing the first surface. The functional member can be configured to fit within a body lumen. The functional member can include binding elements configured to bind circulating biomolecules and cells. The functional member can include curved portions that form revolutions around the longitudinal axis of the device.

A microfluidic device including a serum separator, a quantum dot and antibody inlet connected to the serum separator, a quantum dot linked immunosorbent assay (QLISA) chamber connected to the serum separator, and an outlet connected to the QLISA chamber. The microfluidic device is configured to determine an amount of drug in a serum.

Multi-directional microfluidic devices and methods for using the same are provided. Aspects of the present disclosure include microfluidic devices that include a chamber having a separation medium, a first binding medium, and a second binding medium. In addition, the devices include a flow field element configured to subject the chamber to two or more directionally distinct flow fields. Methods of using the devices, as well as systems and kits that include the devices are also provided. The devices, systems and methods find use in a variety of different applications, including diagnostic, research and validation assays.

A sample is added to a chamber (12) in which magnetic particles (P) are provided. The sample includes a target component (T) and the chamber (12) has a detection surface (122). A magnetic force is exerted on the magnetic particles (P) to attract the magnetic particles (P) to the detection surface (122). The bound magnetic particles that captured the target component (T) in the magnetic particles (P) and the unbound magnetic particles that captured no target component (T) in the magnetic particles (P) are held at the detection surface (122). At least part of the sample is drained out of the chamber (12) and a new sample added to the chamber (12). The magnetic force exerted on the magnetic particles (P) is altered to release the unbound magnetic particles from the detection surface (122). An amount of the bound magnetic particles that are held at the detection surface (122) are measured. The target component (T) is preconcentrated by repeating the steps of magnetically binding the target component (T) from the newly added sample and washing the detection surface (122) from unbound magnetic particles.

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.