A device for detecting the presence of a target in a sample including a first port configured to receive a multi-layered substrate having a sample inlet and a reagent inlet. The sample inlet is connected to a first microfluidic channel and the reagent inlet is connected to both the first microfluidic channel and a second microfluidic channel. The second microfluidic channel has a longer pathway than the first microfluidic channel. A first test strip and a second test strip are each connected to both the first microfluidic channel and the second microfluidic channel, while a third test strip is connected only to the first microfluidic channel. Each test strip includes a conjugate section, a detection section, and a collection section.

The present invention provides a microfluidic system, method and kit for performing assays. The system may comprise a microfluidic device and a detector, wherein the assay yields results that may be read by a detector and analyzed by the system. The assay may comprise one or more chemical or biological reaction against, or performed on, a sample or multiple samples. The sample(s) may become larger and/or smaller during the performance of the assay. The sample(s) may be present within a vehicle, or on a carrier within a vehicle, in the microfluidic device, and wherein the vehicle may become larger and/or smaller during the performance of the assay. The assay may be a cascading assay comprising a series of multiple assays, wherein each assay may be the same or different, and wherein each assay in the series of multiple assays may further comprise one or more process or step.

Systems, including apparatus and methods, for the microfluidic manipulation, dispensing, and/or sorting of particles, such as cells and/or beads.

A test device is configured for diagnostic testing and includes an optical readable medium, in turn including a pattern of spots of material arranged on a surface of the device. Several patterns may be provided. The patterns accordingly formed may be human and/or machine readable. They may notably encode security information, e.g., indicating whether the device has already been used. The spots may notably be inkjet spotted. In addition, a method is provided for decoding information encoded in a pattern of such a test device. In embodiments, liquid is introduced in the device, which comprises additional spots having a substantially different solubility than spots forming the actual pattern. Thus, the additional spots get solubilized in and flushed by the liquid as the latter wets them, and an initially hidden pattern may be read, which is formed of the remaining spots (not solubilized). Encoding methods are also provided.

Provided herein are coded fluid paths. Also provided herein are devices and systems containing one or more of the coded fluid paths. Also provided herein are methods of using the coded fluid paths, devices, and systems provided herein.

An analysis unit formed by an analysis body housing an analysis chamber and having a sample inlet and a supply channel configured to fluidically connect the sample inlet to the analysis chamber. Dried assay reagents are arranged in the analysis chamber and are contained in an alveolar mass. For instance, the alveolar mass is a lyophilized mass formed by excipients and by assay-specific reagents.

A solid reagent containment unit is formed by a support; a frame body fixed to the support and delimiting internally, together with the support, an analysis volume; a reagent-adhesion structure within the analysis volume; and at least one reagent cavity, which extends within the reagent-adhesion structure. The reagent-adhesion structure is of an adhesion material embossable at temperatures lower by 6-8? C. than its own melting point and has a melting point such as not to interfere with the analysis. The reagent cavity forms a retention wall, laterally surrounding the reagent cavity, and houses dried reagents. The adhesion material is chosen among wax, such as paraffin, a polymer, such as polycaprolactone, a solid fat, such as cocoa butter, and a gel, such as hydrogel or organogel.

A field portable diagnostic apparatus uses a rotatable disk in which a microfluidic circuit is defined. The microfluidic circuit includes a centrifugal separation chamber receiving a sample to stratify the sample. A magnetic bead holding chamber is communicated to a mixing chamber, where mass amplifying functionalized magnetic-nanoparticles, held in a buffer solution and contained in the magnetic bead holding reservoir communicated to mixing chamber, are mixed with the separated fluid delivered to mixing chamber from the separation chamber. The functionalized magnetic nanoparticles conjugate with a target analyte in the sample. A magnet in proximity to a SAW chamber including a SAW detector draws the functionalized magnetic nanoparticles toward antibodies immobilized on the SAW sensor surface A wash reservoir is communicated to the SAW sensor chamber, and a cleanup/waste reservoir is communicated to the SAW chamber for receive fluid after it has passed through the SAW chamber.

Disclosed is a lateral flow capillary device and uses thereof comprising a unipath bibulous capillary flow matrix and at least two reservoirs each in fluid communication with the capillary flow matrix wherein a reservoir contacts the capillary flow matrix through a passage having a rim pressing the matrix. The pressure that the rim applies on the matrix prevents leakage of liquids out of the capillary flow matrix at the reservoir/matrix interface, allowing accurate sequential draining of liquid from the reservoirs. During use of the disclosed lateral flow capillary device a static interface is formed between the first liquid and the second liquid in an interface creation zone inside the capillary flow matrix wherein the first amount and second amount are such that first liquid substantially remains in the first reservoir and the second liquid substantially remains in the second reservoir subsequent to the formation of the static interface and wherein the interface begins to move only subsequent to exhaustion of a liquid from a reservoir.

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. Because the system is non-lytic, the testing can be repeated on the cells which remain viable in culture. Also provided is a method for enriching test samples having circulating tumor cells and a microfluidics device suitable for CTC-specification identification and enumeration.