The present invention relates to a biological sample collection kit, which uses a unique dry preservative for the preservation of nucleic acids, DNA and RNA, for collection, stabilization, transportation and long-term room temperature storage of biological samples that can be from sources such as saliva for molecular diagnostic applications. The invention features a collection device for biological samples such as saliva containing nucleic acids, and dry preservatives that are affixed directly or to a carrier substrate and placed within the collection device such that the samples come into contact with the dry preservatives resulting in the preservation and stabilization of the nucleic acids.

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.

A method and apparatus for minimizing diagnostic errors due to transposition of biological specimens among subjects provides for independent biometric confirmation that a given specimen is from a given donor. In certain embodiments, a biological specimen confirmation kit comprises a portable and openable case housing components of the kit, at least one biological specimen container adapted to receive a biological testing specimen from a donor, and at least one reference sample device adapted to receive a biological reference specimen from the same donor, such that the testing and reference specimens can later be compared for donor match verification by a reference verification entity.

A system, methods, and apparatus are described to collect and prepare cells, nuclei, subcellular components, and biomolecules from specimens including FFPE and OCT preserved tissues. The system can perform deparaffinization, rehydration, enzymatic and/or chemical and physical disruption of the FFPE tissue, or residue removal of the OCT tissue, to dissociate it into a single cell or nuclei suspension.

A method for preparing for preparing a solution comprising a plurality of particles in a vial is disclosed. The method includes agitating the vial at a first predetermined mixing speed. The method also includes dispersing, into the vial, during the agitating, a first volume of buffer solution at a first predetermined dispensing rate to suspend the plurality of particles in the solution, wherein particles of the plurality of particles comprise a unique identifying feature.

Sub-millimeter scale three-dimensional (3D) structures are disclosed with customizable chemical properties and/or functionality. The 3D structures are referred to as drop-carrier particles. The drop-carrier particles allow the selective association of one solution (i.e., a dispersed phased) with an interior portion of each of the drop-carrier particles, while a second non-miscible solution (i.e., a continuous phase) associates with an exterior portion of each of the drop-carrier particles due to the specific chemical and/or physical properties of the interior and exterior regions of the drop-carrier particles. The combined drop-carrier particle with the dispersed phase contained therein is referred to as a particle-drop. The selective association results in compartmentalization of the dispersed phase solution into sub-microliter-sized volumes contained in the drop-carrier particles. The compartmentalized volumes can be used for single-molecule assays as well as single-cell, and other single-entity assays.

Disclosed is a microfluidic biosensing system including a processor, in which a Raman barcode database corresponding to at least one Raman spectrum signal is stored, a plurality of Raman barcode beads mixed with a target fluid and coupled to at least one target bioparticle in the target fluid, a microfluidic channel disposed to make the target fluid mixed with the Raman barcode beads flow therethrough, a light source disposed on the microfluidic channel, and a spectral detection device connected to the processor and disposed to correspond to the light source. The spectral detection device receives the Raman spectrum signal generated when the target bioparticle coupled with the Raman barcode bead is irradiated, and transfers the received Raman spectrum signal to the processor. The processor determines a type of the bioparticle(s) and calculates the number of bioparticle(s) by matching the Raman spectrum signal(s) to the Raman barcode database.

A lateral flow assay (LFA) device includes a capillary pad and a sample port that holds the sample fluid before a hole is made in a cavity surface of the sample port. The LFA device includes a breaker with a tip to make a hole in the cavity wall of the sample port causing the sample fluid held inside the compartment to be applied to the capillary pad after the start of a test.

The present invention relates to methods, devices and systems for associating consumable data with an assay consumable used in a biological assay. Provided are assay systems and associated consumables, wherein the assay system adjusts one or more steps of an assay protocol based on consumable data specific for that consumable. Various types of consumable data are described, as well as methods of using such data in the conduct of an assay by an assay system. The present invention also relates to consumables (e.g., kits and reagent containers), software, data deployable bundles, computer-readable media, loading carts, instruments, systems, and methods, for performing automated biological assays.

The present invention relates generally to a means of detecting a target molecule, compound or substance through the attractive forces occurring between said target and a target-specific molecular probe whereby said molecular probe expresses a selective high affinity for target and is capable of fluorescent luminescence at a definitive frequency and in a determinable light wave range. Specifically, said molecular probe offers target-specific binding where a resultant duplex molecule fluoresces upon hybridization to a target's unique molecule nucleotide sequence. Said hybridization allows for optical detection of said duplex via a directed, filtered and focused light source which makes said duplex both quantifiable and quantifiable via luminescence (i.e., light wave excitation) and subsequent photo detection utilizing ellipsoidal reflection to amplify detection and measurement improving both sensitivity and specificity.