Provided herein are devices, systems, kits and methods for obtaining genetic information from cell-free fetal nucleic acids in ultra-low amounts of biological samples. Due to the convenience of obtaining ultra-low amounts of samples, devices, systems, kits and methods can be at least partially employed at a point of need.

A blood-viscosity measurement method uses a collection tube includes a bottomed tube having an opening at one end in a length direction and a bottom at the other end in the length direction. A sealing plug includes a sealing part fitted in the opening of the bottomed tube in a hermetically sealed state, a cap part, and a thin connecting part. The sealing part includes a vertically penetrated insertion hole and fitted in the opening of the bottomed tube. The method includes collecting blood using a negative pressure state of the inner space, applying an external force to the cap portion to break the connecting part and removing the cap part to expose the insertion hole at an upper surface of the sealing part, and obtaining blood viscosity by causing a viscosity-measurement falling body to fall from the insertion hole, and measuring a fall terminal velocity of the falling body.

A bodily-fluid transfer 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 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.

A device for collecting blood from a mammalian subject without using spontaneous capillary blood flow, the device including a collection cup subassembly having a cantilevered, concave slide for transporting blood down and away from a blood sampling location; a mid-body subassembly couplable to the collection cup assembly and including a housing having a proximal end and a distal end and defining a plenum space; and a plunger subassembly having a first end and a second end and including a plunger formed at the second end and one or more lancet elements attached to the plunger. Advantageously, the plunger and lancet elements are structured and arranged to translate through the mid-body subassembly and the collection cup subassembly to the blood sampling location.

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.

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.

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.

Systems and methods for assessing a flow of fluids suctioned from a patient. The flow of fluids may be divided according to a flow division ratio. An image of a first portion of the fluids may be evaluated to determine an estimated blood component quantity as a representative fraction of the flow of fluids. An intermittent estimate of blood loss may be determined based on the flow division ratio and the estimated blood component quantity, and a total estimate of blood loss updated based on the intermittent estimate. The representative fraction is projected or extended to be an estimated blood component quantity of the second portion of the fluids that bypasses the receptacle. The images may be continuously captured with a camera, and a fluid level of the fluids with a receptable may be continuously monitored. The total estimate of blood loss may be displayed in real-time on a display.

The present disclosure generally relates to receiving bodily fluid through a device opening. In one aspect, the device includes an interface that facilitates piercing of skin and/or withdrawal of fluid from the skin. The skin may be subjected to vacuum from a vacuum source.

A vacuum pad may include a top layer forming a top surface of the vacuum pad; a bottom layer forming a bottom surface of the vacuum pad; and a plurality of spacers located between the top layer and the bottom layer such that an interior space is formed between the top layer and the bottom layer. The interior space may have at least one channel extending around at least one spacer of the plurality of spacers. The vacuum pad may also include an outlet tube in fluid communication with the interior space, where the top layer includes a plurality of holes. A vacuum system may include the vacuum pad along with a canister and a vacuum source for moving fluid from the vacuum pad to the canister.