A system and method are provided for collection and testing of a biologic sample in a self-diagnostic test. The system and method comprise collecting by a user of a testing device a biologic sample for use with the testing device, assigning correlative values as test results, and receiving the test results at a server disposed on a network. Some aspects include a mobile application operating on a mobile device with which the user interacts. These aspects allow advertisements and other messages to be presented to the user through the mobile application. Some aspects present different messages to the user based on the type of self-diagnostic test the user is conducting.

An integrated testing device and fluid module are disclosed, as well as a method of manufacture. Fluid module contains a reservoir containing a test fluid, and a control vessel. The reservoir discharges test fluid into the control vessel, which discharges the test fluid in a controlled way to a test component.

The present it relates to a sensor applicator assembly for a continuous glucose monitoring system and provides a sensor applicator assembly for a continuous glucose monitoring system, which is manufactured with a sensor module assembled inside an applicator, thereby minimizing additional work by a user for attaching the sensor module to the body and allowing the sensor module to be attached to the body simply by operating the applicator, and thus can be used more conveniently. A battery is built in the sensor module and a separate transmitter is connected to the sensor module so as to receive power supply from the sensor module and be continuously used semi-permanently, thereby making the assembly economical. The sensor module and the applicator are used as disposables, thereby allowing accurate and safe use and convenient maintenance.

A method of measuring body fluid content, the method comprising computer executed steps, the steps comprising: receiving a value of a temperature of a body part of a subject, and generating corrective data based on the received measured temperature value and on previously gathered data, the corrective data being usable for correcting a measurement of content of a fluid sample taken from the body part.

Devices and methods for withdrawing bodily fluid from a subject are disclosed herein. In some embodiments, a handheld device can include a housing having an opening, a skin-piercing assembly, and an actuator coupled to the skin-piercing assembly. The skin-piercing assembly can include a casing, a drive member pivotably mounted within the casing and carrying a blade, and a biasing member coupling the drive member to the casing. The actuator can be movable relative to the housing from a first position to a second position. In the first position, the drive member can engage the casing to maintain the biasing member in a biased configuration. Movement of the actuator from the first position to the second position can disengage the drive member from the casing to permit the biasing member to drive the blade at least partially through and/or across the opening in the base.

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.

The presence of biomarkers or other analytes can be detected in the bodily fluid using Electrochemical Impedance Spectroscopy (EIS) or Electrochemical Capacitance Spectroscopy (ECS) in devices, such as handheld point-of-care devices. The devices, as well as systems and methods, utilize using Electrochemical Impedance Spectroscopy (EIS) or Electrochemical Capacitance Spectroscopy (EIS) in combination with an antibody or other target-capturing molecule on a working electrode. Imaginary impedance or phase shift, as well as background subtraction, also may be utilized.

The present disclosure relates to an insertion guide needle for a continuous glucose monitoring system. The insertion guide needle makes an incision in the skin by means of point-contact with the skin during a skin insertion process, and allows expanded incision of the skin continuously thereafter, thereby minimizing pain which may occur during the skin insertion process and thus relieving aversion or tension when the continuous glucose monitoring system is used. During a process of expanded incision of the skin, the insertion guide needle allows expanded incision continuously and gradually in the width direction and thickness direction, thereby reducing skin resistance during the expanded incision process and further reducing pain. In addition, during the expanded incision process, since the entire incision area is formed by an incision, the insertion guide needle is simply inserted along the incision area after a predetermined insertion section, such that almost no pain occurs during the insertion process.

A sample collection container configured to be removably mounted to a blood collection device includes: a housing having a flow channel extending through the housing having an inlet and an outlet and a container body removably connected to the housing. The container body includes an open top, a closed bottom, and an interior wall extending between the top and the bottom defining a collection cavity. When the housing is connected to the container body, the outlet of the flow channel is in fluid communication with the collection cavity. The sample collection container also includes at least one additive dispersing object positioned to be contacted by blood flowing from the blood collection device through the flow channel and/or into the collection cavity. The at least one additive dispersing object includes an additive composition to be mixed with the blood passing along the flow channel and into the collection cavity.

This invention is in the field of medical devices. Specifically, the present invention provides fluidic systems having a plurality of reaction sites surrounded by optical barriers to reduce the amount of optical cross-talk between signals detected from various reaction sites. The invention also provides a method of manufacturing fluidic systems and methods of using the systems.