Devices for detecting microorganism strains or target cellular analytes are provided. The device includes a filter holder, the filter holder comprising a tip portion; a nonwoven article disposed on the tip portion of the filter holder; and an adaptor attacked to the filter holder, the adaptor defining an aperture. Methods of detecting microorganisms and/or cellular analytes in a fluid sample using the devices are also provided. The method includes obtaining the device; placing a lumened or cannulated device in fluid communication with the device; and passing a fluid sample suspected of containing at least one microorganism strain or target cellular analyte from the lumened or cannulated device through the device and contacting the nonwoven article. The method further includes contacting the nonwoven article with at least one detection reagent and detecting the presence of the at least one microorganism strain or target cellular analyte concentrated by the nonwoven article. Kits and systems including the devices are also provided.

A system for collecting, growing, and analyzing biological specimens that may present a health threat. The system includes separate modules for specimen collection, sample isolation, and sample analysis that can be interconnected to safety process, culture, and analyze and unknown specimen. A decapitation module allows a user to safely collect a swab tip containing an unknown sample and transport the sample to a culture module where the sample can be washed from the swab tip and isolated in a cuvette for growth and analysis. The culture module may be coupled to a base station that can provide mixing, heating and cooling, as well as optical and spectral analysis.

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.

Systems and methods for detecting the presence of a target nucleic acid in a sample via a recombinase polymerase amplification (RPA) reaction followed by a FEN1 cleavage detection reaction are disclosed. One aspect of the present disclosure relates to systems involving a sample collection device for collecting a sample and performing an RPA reaction on the sample, followed by the detection of the amplified product via a two-step FEN1 cleavage detection reaction which generates a fluorescent signal indicative of the presence of amplified product.

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.

The invention provides devices that improve tests for detecting specific cellular, viral, and molecular targets in clinical, industrial, or environmental samples. The invention permits efficient detection of individual microscopic targets at low magnification for highly sensitive testing. The invention does not require washing steps and thus allows sensitive and specific detection while simplifying manual operation and lowering costs and complexity in automated operation. In short, the invention provides devices that can deliver rapid, accurate, and quantitative, easy-to-use, and cost-effective tests.

An integrated nucleic acid processing apparatus includes a first operation area, a second operation area and a separation wall. The first operation area includes multiple carrying boards for placing objects and reagents for processing nucleic acids in samples, and multiple operation modules for performing operations of nucleic acid processing. The second operation area includes two extraction regions for respectively performing nucleic acid extractions. The separation wall separates the first operation area from the second operation area and includes two openable door sheets spatially corresponding to the two extraction regions. Nucleic acid extraction plates can be moved from the first operation area to the second operation area by means of the carrying boards as the two openable door sheets are opened, and be isolated in the second operation area for performing nucleic acid extractions as the two openable door sheets are closed.

Contamination detection systems, kits, and techniques are described for testing surfaces for the presence of hazardous contaminants, while minimizing user exposure to these contaminants. Even trace amounts of contaminants can be detected. A collection kit provides a swab that is simple to use, easy to hold and grip, allows the user to swab large areas of a surface, and keeps the user's hands away from the surface being tested. The kit also provides open and closed fluid transfer mechanism to transfer the collected fluid to a detection device while minimizing user exposure to hazardous contaminants in the collected fluid. Contamination detection kits can rapidly collect and detect hazardous drugs, including trace amounts of antineoplastic agents, in healthcare settings at the site of contamination.

The present invention generally relates to a sample receiving device for releasably storing a substance. The sample receiving device includes a lid having a reservoir for retaining the substance, and a pierceable barrier sealing the substance within the reservoir; and b) a funnel for receiving a sample and configured for closure by the lid. The funnel is configured for releasable attachment to a sample receptacle such that a sample can be provided to the funnel and travel through the channel in the funnel into the sample receptacle. Further, the funnel includes one or more cutting ribs for cutting the pierceable barrier such that upon cutting of the pierceable barrier the substance is released from the reservoir, flows through the channel in the funnel and into the sample receptacle to be mixed with the sample. The present invention also provides a kit for collecting and storing biomolecules.

Assay system including assay apparatus and handheld single use assay devices for ElectroMagnetic Radiation (EMR) examination of a specimen. The assay devices include a housing, a specimen slide for elevation from an initial lowermost specimen introduction position to a final uppermost specimen examination position and a built-in liquid reagent dispensing arrangement for dispensing liquid reagent on the specimen slide. The assay apparatus automatically actuates an assay device and includes an imaging arrangement for obtaining specimen images.