Opko Diagnostics, LLC

Gen-probe, Inc.

Qualigen, Inc.

Upko Diagnostics, LLC

Claros Diagnostics, Inc.

Jason Taylor

Vincent Linder

David Steinmiller

Norman C Nelson

Richard S Lee

Matthew J Scott

Scott S Breidenthal

Sara H Fan

Matthew Dirckx

Enqing Tan

Hardeep Singh

John DePiano

Daniel L Kacian

Michael Poirier

Gary J Fagan

Scott Breidenthal

Greg Kenny

Rebecca Wagner

Richard Lee

Matthew Scott

Systems and methods for analysis of samples, and in certain embodiments, microfluidic sample analyzers configured to receive a cassette containing a sample therein to perform an analysis of the sample are described. The microfluidic sample analyzers may be used to control fluid flow, mixing, and sample analysis in a variety of microfluidic systems such as microfluidic point-of-care diagnostic platforms. Advantageously, the microfluidic sample analyzers may be, in some embodiments, inexpensive, reduced in size compared to conventional bench top systems, and simple to use. Cassettes that can operate with the sample analyzers are also described.

Systems and devices for analysis of samples

Fluidic devices and methods are provided.

Fluidic systems comprising an incubation channel, including fluidic systems formed by molding

A receptacle comprises opposed members, a plurality of chambers having perimeter walls defined by seals formed between the opposed members and portals interconnecting the chambers, and a rigid frame supporting the opposed members at their peripheral edges. The frame comprises a front frame portion and a rear frame portion, and the peripheral edges of the opposed members are retained between the front and rear frame portions. An inlet port extends between the front and rear frame portions and is in fluid communication with one of the chambers.

System and method of using multi-chambered receptacles

A method of processing a sample in a receptacle comprising a plurality of chambers. Each of the chambers is connected to at least one other chamber by a portal and at least a first one of the chambers is formed of a flexible material. The method includes the steps of causing gas bubbles contained in the first chamber to accumulate in a portion of the first chamber, applying a compressive external force to the first chamber to cause some or all of the liquid contents of the first chamber to flow into an interconnected second chamber through a portal connecting the first and second chambers; and preventing the gas bubbles accumulated in a portion of the first chamber from flowing through the portal into the second chamber.

Articles and methods for preparing a surface for obtaining a patient sample, such as blood, are generally provided. In some embodiments, the methods involve wiping a surface of skin of a patient in preparation for obtaining a sample (e.g., a blood sample) from the patient. In some embodiments, the methods involve wiping the surface of the skin with two or more wipes. For instance, the surface of the skin may be wiped with a first wipe comprising a surfactant and a second wipe comprising an antiseptic solution. Advantageously, the use of a first wipe including a surfactant followed by a second wipe may remove a higher amount of certain contaminants (e.g., proteins, bacteria, viruses) from the surface of the skin as compared to the use of a single wipe or by hand-washing alone.

Articles and methods for preparing a surface for obtaining a patent sample

The specification generally discloses systems and methods for mixing and delivering fluids in microfluidic systems. The fluids can contain, in some embodiments reagents that can participate in one or more chemical or biological reactions. Some embodiments relate to systems and methods employing one or more vent valves to controllably flow and/or mix portions of fluid within the microfluidic system. Advantageously, fluid control such as a sequence of fluid flow and/or a change in flow rate, can be achieved by opening and closing one or more vent valves and by applying a single source of fluid flow (e.g., a vacuum) operated at a substantially constant pressure. This can simplify the operation and use of the device by an intended user.

Fluid mixing and delivery in microfluidic systems

Articles and methods for collecting and/or facilitating transfer of fluids are generally provided. In some embodiments, an article comprises a fluid collection region for introducing a fluid, such as a sample (e.g., blood sample) or a reagent, into a fluidic system. The articles and methods described herein may be useful for facilitating the filling of relatively small channels with a fluid, such as channels of a microfluidic device. The articles and methods may, for example, interface with a patient sample (e.g., a droplet of blood), or with a macroscopic fluid source such as a pipette or syringe. In certain embodiments, articles and methods described herein may increase the ease of collecting a fluidic sample from a patient, prevent or reduce spillage of the fluidic sample, reduce contamination of a fluidic sample, and/or prevent or reduce air from entering a fluidic sample or device compared to certain existing fluid collection devices.

Fluid collection device and related methods

A receptacle having a plurality of interconnected chambers arranged to permit multiple process steps or processes to be performed independently or simultaneously. The receptacles are manufactured to separate liquid from dried reagents and to maintain the stability of the dried reagents. An immiscible liquid, such as an oil, is included to control loading of process materials, facilitate mixing and reconstitution of dried reagents, limit evaporation, control heating of reaction materials, concentrate solid support materials to prevent clogging of fluid connections, provide minimum volumes for fluid transfers, and to prevent process materials from sticking to chamber surfaces. The receptacles can be adapted for use in systems having a processing instrument that includes an actuator system for selectively moving fluid substances between chambers and a detector. The actuator system can be arranged to concentrate an analyte present in a sample. The detector can be used to detect an optical signal emitted by the contents of the receptacle.

Multi-chambered receptacles

Fluidic devices and methods associated with mixing of fluids in fluidic devices are provided. In some embodiments, a method may involve the mixing of two or more fluids in a channel segment of a fluidic device. The fluids may be in the form of, for example, at least first, second and third fluid plugs, composed of first, second, and third fluids, respectively. The second fluid may be immiscible with the first and third fluids. In certain embodiments, the fluid plugs may be flowed in series in the channel segment, e.g., in linear order, causing the first and third fluids to mix without the use of active components such as mixers. The mixing of fluids in a channel segment as described herein may allow for improved performance and simplification in the design and operations of fluidic devices that rely on mixing of fluids.

Mixing of fluids in fluidic systems

Fluidic devices and methods including those that provide storage and/or facilitate fluid handling of reagents are provided. Fluidic devices described herein may include channel segments positioned on two sides of an article, optionally connected by an intervening channel passing through the article. The channel segments may be used to store reagents in the device prior to first use by an end user. The stored reagents may include fluid plugs positioned in linear order so that during use, as fluids flow to a reaction site, they are delivered in a predetermined sequence. The specific geometries of the channel segments and the positions of the channel segments within the fluidic devices described herein may allow fluid reagents to be stored for extended periods of time without mixing, even during routine handling of the devices such as during shipping of the devices, and when the devices are subjected to physical shock or vibration.

Reagent storage in microfluidic systems and related articles and methods

Fluidic devices and methods involving incubation and/or mixing of assay components are provided. In some embodiments, a biological and/or chemical assay may be performed in a fluidic device. The fluidic device may be designed to allow for controlled incubation and/or mixing of two or more assay components. In some such embodiments, the fluidic device may include an incubation channel having a relatively large cross-sectional dimension in fluid communication with a detection channel. The incubation channel may allow for adequate mixing and/or incubation of two or more assay components prior to analysis of the assay. In certain embodiments, the detection channel may be used to provide feedback on the extent of incubation and/or mixing. Based on the feedback, one or more component of the fluidic system may be regulated to allow the requisite degree of mixing and/or incubation to be achieved.

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Windham, NH, United States of America

Jason Taylor