The invention provides an improved method for sensitive and specific detection of target molecules, cells, or viruses. The inventive method uses large area imaging to detect individual labeled targets complexed with a target-specific selection moiety. The invention eliminates wash steps through the use of target-specific selection through one or more liquid layers that can contain optical dye and density agents. By eliminating washes the invention simplifies instrumentation engineering and minimizes user steps and costs. The invention uses sensitive image analysis to enumerate individual targets in a large area, is scalable, and can be deployed in systems ranging in complexity from manual to highly automated.

A needle guide assembly for vein access including (a) a guide having a convex portion, a concave portion, an aperture and a stabilization means for stabilizing a vein against moving away and escape puncture, where the concave portion and the convex portion meet each other to define the aperture between the concave portion and the convex portion, each of the convex portion and the concave portion extending away from the aperture in opposite directions from each other in a tapering manner and terminating the tapering at respective locations away from the peripheral edge, the convex portion being made of a transparent or translucent material, the stabilization means being a pair of elongated indentations that extend substantially parallel to each other and between which are the convex portion, the concave portion and the aperture, and (b) a retaining means for retaining the guide to skin. A venipuncture method is includes retaining the needle guide assembly onto the skin of a patient and using the needle guide assembly to guide a needle to puncture the skin and access a vein.

The present disclosure relates to a device for analyzing a fluid sample. In one aspect, the device includes a fluidic substrate that comprises a micro-fluidic component embedded in the fluidic substrate configured to propagate a fluid sample via capillary force through the device and a means for providing a fluid sample connected to the micro-fluidic component. The device also includes a lid attached to the fluidic substrate at least partly covering the fluidic substrate and at least partly closing the micro-fluidic component. The fluidic substrate may be a silicon fluidic substrate and the lid may be a CMOS chip. In another aspect, embodiments of the present disclosure relate to a method for fabricating such a device, and the method may include providing a fluidic substrate, providing a lid, and attaching, through a CMOS compatible bonding process, the fluidic substrate to the lid to close the fluidic substrate at least partly.

A method of constructing a point-of-care diagnostic apparatus and fluid storage and delivery apparatus therefor is provided. The method of constructing the fluid storage and delivery apparatus includes providing a flexible upper layer having a reservoir; providing a flexible lower layer having a valve member; providing a rigid substrate having an upper surface, a lower surface and a through port; disposing a fluid in the reservoir; and sandwiching the rigid substrate between the upper and lower layers and bonding the upper layer to the upper surface of the rigid substrate with the reservoir registered with the through port and bonding the lower layer to the lower surface of the rigid substrate with the valve member registered with the through port. The method of constructing the point-of-care diagnostic apparatus includes fixing the fluid storage and delivery apparatus to a rigid base in selective fluid communication with a reaction chamber.

An automatically locking safety device, e.g., for use in a blood collection procedure, can include a housing, first and second needle covers that are at least partly received in the housing, and a needle that is at least partly received in at least one of the first and second needle covers. The needle can include a proximal tip configured for placement into a patient and a distal tip configured for placement into a blood collection vial. In some embodiments, the first and second needle covers are biased by a biasing member. In some cases, one or both of the first and second needle covers can be locked to prevent axial movement thereof after the blood collection procedure. In certain embodiments, a distal end of the device is configured to connect with a medical connector, such as a needleless IV access device.

Methods of molding a barrel, such as a syringe barrel having very low draft, are disclosed. Thermoplastic syringes having very low interior draft angels are also disclosed.

An automatically locking safety device, e.g., for use in a blood collection procedure, can include a housing, first and second needle covers that are at least partly received in the housing, and a needle that is at least partly received in at least one of the first and second needle covers. The needle can include a proximal tip configured for placement into a patient and a distal tip configured for placement into a blood collection vial. In some embodiments, the first and second needle covers are biased by a biasing member. In some cases, one or both of the first and second needle covers can be locked to prevent axial movement thereof after the blood collection procedure. In certain embodiments, a distal end of the device is configured to connect with a medical connector, such as a needleless IV access device.

Methods for intra-mold sterilization of a plastic-embedded metal component of a product, such as a medical lancet having a metal needle embedded within a plastic lancet body. For example, a lancet needle is retained within a mold, plastic is injected to encapsulate the needle, and a specified minimum temperature is maintained for a specified minimum cycle time. In example forms, the specified minimum mold temperature is at least about 370 degrees Fahrenheit and the specified minimum cycle time is at least about 10 seconds.

Blood sample optimization systems and methods are described that reduce or eliminate contaminates in collected blood samples, which in turn reduces or eliminates false positive readings in blood cultures or other testing of collected blood samples. A blood sample optimization system can include a blood sequestration device located between a patient needle and a sample needle. The blood sequestration device can include a sequestration chamber for sequestering an initial, potentially contaminated aliquot of blood, and may further include a sampling channel that bypasses the sequestration chamber to convey likely uncontaminated blood between the patient needle and the sample needle after the initial aliquot of blood is sequestered in the sequestration chamber.

The present invention relates to an innovative blood collection system including a blood collection device, or blotter, designed to efficiently and in an environmentally responsible manner collect blood samples from finger prick or other wounds, and then optionally provide a convenient vehicle for the blood sample to be sent for processing and analysis without having to transport the patient to a clinic and back.