Devices and methods are provided that permit efficient and selective separation of liquid biological specimens into at least two constituent components to facilitate subsequent quantitative and qualitative analysis on at least one analyte of interest in at least one of the components. For example, a liquid biological specimen separation device includes a base defining a base surface, a collection housing extending away from the base surface to a collection end, a collection membrane disposed on the collection housing adjacent the collection end, and a cap assembly secured to the collection housing. The cap assembly includes a cap defining an aperture therein configured to allow deposition of a liquid biological specimen therethrough, a separation membrane secured to the cap and extending across the aperture, a cap ring rotatably secured about the collection housing, and a tether coupling the cap to the cap ring.

The present invention provides methods of calibrating a fluidic device useful for detecting an analyte of interest in a bodily fluid. The invention also provides methods for assessing the reliability of an assay for an analyte in a bodily fluid with the use of a fluidic device. Another aspect of the invention is a method for performing a trend analysis on the concentration of an analyte in a subject using a fluidic device.

Bodily fluid sample collection systems, devices, and method are provided. The device may comprise a first portion comprising at least a sample collection channel configured to draw the fluid sample into the sample collection channel via a first type of motive force. The sample collection device may include a second portion comprising a sample container for receiving the bodily fluid sample collected in the sample collection channel, the sample container operably engagable to be in fluid communication with the collection channel, whereupon when fluid communication is established, the container provides a second motive force different from the first motive force to move a majority of the bodily fluid sample from the channel into the container.

The present invention relates generally to a sampling apparatus and a method for bodily fluids, and, more specifically, a blood sampling apparatus and a method for using the same. A blood collection system includes a housing having at least one open end, and an absorbent material positioned within the housing. The absorbent material has at least one end positioned proximate the at least one open end of the housing. A method of collecting blood samples includes positioning an absorbent material near a source of blood, holding the absorbent material with a housing, the absorbent material absorbing a volume of blood, and moving the housing and absorbent material to a position where the absorbent material can dry.

The present disclosure relates to a cartridge, detection module, system, and kit for cell and particle detection and analysis. Devices disclosed herein may include at least an optical source, a fluidic chip, and a detection module, wherein the sample flows within the fluidic chip past a detection window, where the cells or particles are imaged by an image acquisition and analysis module that may include an optical detector. The image acquisition and analysis module may count the cells or particles of interest in real-time, or near real-time, or the module may capture images of the cells in order to analyze the sample from combined images at a later time.

Methods and devices are provided for sample collection and sample separation. In one embodiment, a device is provided for use with a formed component liquid sample, the device comprising at least one sample inlet for receiving said sample; at least a first outlet for outputting only a liquid portion of the formed component liquid sample; at least a second outlet for outputting the formed component liquid sample at least a first material mixed therein.

This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications.

The present invention provides methods of calibrating a fluidic device useful for detecting an analyte of interest in a bodily fluid. The invention also provides methods for assessing the reliability of an assay for an analyte in a bodily fluid with the use of a fluidic device. Another aspect of the invention is a method for performing a trend analysis on the concentration of an analyte in a subject using a fluidic device.

Bodily fluid sample collection systems, devices, and method are provided. The device may comprise a first portion comprising at least a sample collection channel configured to draw the fluid sample into the sample collection channel via a first type of motive force. The sample collection device may include a second portion comprising a sample container for receiving the bodily fluid sample collected in the sample collection channel, the sample container operably engagable to be in fluid communication with the collection channel, whereupon when fluid communication is established, the container provides a second motive force different from the first motive force to move a majority of the bodily fluid sample from the channel into the container.

This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications.