The present invention relates to sample-to-answer systems, devices, cartridges, and method of using the same for detecting the presence of microorganisms in a sample, such as bacteria.

The present invention provides methods and devices for simple, low power, automated processing of biological samples through multiple sample preparation and assay steps. The methods and devices described facilitate the point-of-care implementation of complex diagnostic assays in equipment-free, non-laboratory settings.

A diagnostic cartridge and method of performing a diagnostic test are provided. The cartridge includes a body having a sample chamber for receipt of a sample, an analysis chamber, and a reagent-containing dispensing member. A valve member is coupled to the body for selective movement between first and second states. The valve member has a fluid passage with a hydroscopic, gas permeable vent. In the first state, the fluid passage is out of fluid communication with the sample chamber and is registered for fluid communication with the reagent-containing dispensing member. The vent prevents fluid from passing therethrough and allows air to vent therefrom as reagent flows into and fills the fluid passage. In the second state, the fluid passage remains in fluid communication with the reagent-containing dispensing member and is brought into fluid communication with the sample chamber to facilitate transporting the sample to the analysis chamber.

Embodiments of the present invention are directed to a test kit. The test kit includes an assay tube and a reagent cap. The assay tube includes a sample opening in the assay tube for receiving a sample and a lateral flow assay (“LFA”) test strip in the assay tube in communication with a sample opening. The reagent cap is designed to be placed over the assay tube and includes a buffer. When the reagent cap is placed over the sample opening of the assay tube the buffer is released over the sample to carry an analyte over the LFA test strip.

Systems and methods for performing biological assays are provided herein. The systems and methods determine one or more characteristics of a nucleic acid amplification sample based on a modified optical property of the sample.

Devices and methods for preparing and delivering biological assay samples are provided herein. Components of such devices include a sample receiving module within which a biological assay sample can be prepared and a cap, which when operatively coupled with the sample receiving module, pressurizes the module. These devices can be employed for subsequently delivering a biological assay sample.

Instruments and methods for amplifying nucleic acids in a sample provided in a flexible, self-contained, substantially closed sample container.

A biological sample collection system can include a sample collection vessel having a sample collection chamber with an opening configured to receive a biological sample into the sample collection chamber. The biological sample collection system can additionally include a selectively movable sleeve valve configured to associate with the opening of the sample collection chamber. The biological sample collection system can additionally include a sealing cap that is configured to associate with the selectively movable sleeve valve and with the sample collection vessel. The sealing cap can include a reagent chamber having reagent(s) stored therein, and when the sealing cap is associated with the sample collection vessel, the selectively movable sleeve valve opens, dispensing the reagent(s) into the sample collection chamber.

The invention relates to a test set (1) for a photometric measuring device, comprising a mixing container (2) which has a filling opening (3) and comprising a metering container (8) which can be sealingly inserted into the filling opening (3) of the mixing container (2) and which contains a liquid reagent (13) in a closed cavity (9). The cavity (9) has a closure plunger (11), which can be moved axially in the cavity (9), at a first end of the metering container (8), said closure plunger generating a specifiable filling pressure in the reagent (13), and the metering container (8) has a closure membrane (10) at a second metering container and which can be inserted into the mixing container (2). According to the invention, the closure membrane (10) is equipped with a predetermined breaking point (20) which breaks open when the filling pressure is exceeded in a defined manner as a result of an axial movement of the closure plunger (11), said predetermined breaking point (20) of the closure membrane (10) being formed as a linearly extending material taper of the closure membrane (10), wherein the taper is arranged eccentrically in the region of an opening (24) in the base (23) of the substantially cylindrical metering container (8).

A portable, disposable in-vitro diagnostic apparatus and method of performing a point-of-care invitro-diagnostic test is provided. The apparatus has a body with at least one chamber containing an actuator member. The chamber is in fluid communication with an upstream first fluid channel and a downstream second fluid channel. The actuator member has a compressed, deactivated state and an expanded, activated state. The actuator member transitions from the compressed, deactivated state to the expanded, activated state upon contact with fluid flowing through the first fluid channel. The actuator member pumps fluid outwardly from the first chamber through the second fluid channel during the transition from its compressed, deactivated state to its expanded, activated state. The pumped fluid can be channeled to other chambers within the body and/or to an analysis chamber within the body for study.