Disclosed are liquid and solid assay compositions and portable sample reader devices for use in a sample-to-answer diagnostic system for the detection of one or more analytes, preferably the detection of circulating histones in whole blood. Further provided are methods of making and using the assay compositions and portable sample reader, including the collection of a raw sample, testing the sample using the assay compositions, and analyzing the sample via the portable sample reader. More particularly, assay compositions comprising a sacrificial partition, target molecule, detectable label, and sacrificial partition are used in combination with a sample reader comprising an optical system and a housing unit as part of a sample-to-answer diagnostic system for quantifying circulating histones in whole blood as a mechanism of predicting the risk of multiple organ failure.

An adapter for a syringe having a barrel, a pair of syringe flanges secured to the barrel, and a plunger with a plunger top, the plunger being slidably disposed within the barrel, the adapter having a barrel guide configured to movably surround the barrel, a plunger lock configured to secure the plunger to the adapter, a support body disposed between and associated with the barrel guide and the plunger lock and a front grip associated with the barrel guide. By compressing the syringe flanges and the front grip toward each other, the barrel may travel forward through the barrel guide, thus drawing fluid into the syringe. The adapter, by allowing a compression force to be used to draw a fluid into the syringe, allows an individual to quickly and easily perform a blood draw or other fluid drawing operation with one hand, removing the need for a second user.

A syringe-based device includes a housing, a pre-sample reservoir, and an actuator. The housing defines an inner volume between a substantially open proximal end portion and a distal end portion that includes a port couplable to a lumen-defining device. The pre-sample reservoir is fluidically couplable to the port to receive and isolate a first volume of bodily fluid. The actuator is at least partially disposed in the inner volume and has a proximal end portion that includes an engagement portion and a distal end portion that includes a sealing member. The engagement portion is configured to allow a user to selectively move the actuator between a first configuration such that bodily fluid can flow from the port to the pre-sample reservoir, and a second configuration such that bodily fluid can flow from the port to a sample reservoir defined at least in part by the sealing member and the housing.

In some embodiments, a catheter system may include a catheter adapter having a distal end, a proximal end, and a lumen extending there between. In some embodiments, the catheter system may also include a catheter extending distally from the distal end of the catheter adapter, an extension tube, and a connector coupled to a proximal end of the extension tube. In some embodiments, a distal end of the extension tube may be coupled to the proximal end of the catheter adapter. In some embodiments, the connector, the extension tube, the lumen, and the catheter may form a straight pathway for delivery of an instrument to the catheter system. In some embodiments, an extension set for a catheter assembly may include the extension tube, the connector coupled to the proximal end of the extension tube, and another connector coupled to the distal end of the extension tube.

A specimen collection container is provided, the specimen collection container being capable of suppressing a change in a mixing ratio of a specimen collected to a liquid contained even when a long period of time has elapsed after manufacturing. A specimen collection container according to the present invention is a specimen collection container into which a specimen is collected, the specimen collection container including: a container main body having an opening; a plug attached to the opening; a barrier film disposed on an outer surface of the container main body; and a liquid contained in the container main body, the barrier film having a water vapor transmission rate at 40° C. and 90% RH of 0.8 g/(m.sup.2.Math.day) or less.

A specimen collection container is provided, the specimen collection container being capable of suppressing a change in a mixing ratio of a specimen collected to a liquid contained even when a long period of time has elapsed after manufacturing. A specimen collection container according to the present invention is a specimen collection container into which a specimen is collected, the specimen collection container including: a container main body having an opening; a plug attached to the opening; a barrier film disposed on an outer surface of the container main body; and a liquid contained in the container main body, the barrier film having a water vapor transmission rate at 40° C. and 90% RH of 0.8 g/(m.sup.2.Math.day) or less.

Devices, systems, and methods for storing and/or transporting bodily fluid samples are disclosed herein. In some embodiments, a device for storing and/or transporting a sample of bodily fluid is configured to receive a collection cartridge including a housing and a sample tray removably coupled to the housing. The device can include a base and a cover pivotally coupled to the base. The cover is movable relative to the base between.an open position in which the jig portion is accessible and a closed position in which the jig portion is inaccessible. The base can include a jig portion configured to (a) receive the collection cartridge and (b) decouple the sample tray from a housing of the collection cartridge.

A needle assembly for sampling fluid from a patient including a needle guard, an insertion needle, and a needle housing. The distal end of the needle guard includes a nose portion and a flexible nose extension defining a fluid collection reservoir. The proximal end of the needle guard includes a push feature. The insertion needle has a sharpened distal tip, a proximal needle end and a shaft defining a lumen extending therebetween. The needle housing is operably coupled to the proximal needle end and is slideably coupled to the needle guard. The needle housing includes a flash chamber including a wall defining a cavity. The cavity is in fluid communication with the lumen of the insertion needle and is sealed at one end by a gas permeable flash plug. The push feature selectively engages the flash plug to divert captured bodily fluids to the fluid collection reservoir for sampling.

A point-of-care diagnostic system that includes a cartridge and a reader. The cartridge can contain a patient sample, such as a blood sample. The cartridge is inserted into the reader and the patient sample is analyzed. The reader contains various analysis systems, such as a magneto-optical system that measures a light transmission differential through the patient sample in varying magnetic fields. The reader can process data from the various patient sample analysis to provide interpretative results indicative of a disease, infection and/or condition of the patient.

The present development is a method and device to monitor the salt level in a patient's blood without the need of laboratory facilities or intervention by medical personnel. The basic device is designed to measure the concentration of analytes, specifically sodium ion and potassium ion, in the patient's blood and to communicate the analyte level to the patient essentially instantaneously through a mobile monitor or display screen. In a variation, the device combines the analyte-concentration measuring function with a means for measuring the concentration of glucose in blood, and the blood analyte level and glucose level are displayed to the patient essentially instantaneously. Both the salt level device and the salt level+glucose level device may be further adapted to allow for the salt and glucose level data to be stored in a data storage base so the patient has an historical record of the concentration levels.