Abstract: Methods for diagnosis of HPV infection in a subject are provided. HPV infection in a subject can be determined by generating mass profile data for a biological sample from the subject and correlating the mass profile data with reference mass profiles to detect the presence or absence, and/or quantity of at least one biomarker associated with HPV infection. Methods for detecting at least one biomarker associated with HPV infection in a biological sample are also provided.

Abstract: A system and method for detecting a pathogen in a sample is provided, the system capable of measuring the volume of a sample in a container through the use of various measurement technologies, thereby ensuring that a user is aware of volumes not meeting specification and/or allowing correction of results to account for the out-of-specification sample.

Abstract: A method for detecting oxygen in a test sample is provided, the method involving exposing a test sample and a control sample to sensor compositions having a luminescent compound capable of generating a signal indicative of oxygen depletion. The method further involves determining the strengths of such signals for the test sample versus the control sample, and using the difference to determine whether oxygen in the test sample is being consumed.

Abstract: The invention provides a method and apparatus for determining the presence or absence of respiring cells, involving combining a three-dimensional biomimetic scaffold and cells onto a sensor composition.

Abstract: A shieldable winged needle assembly includes a hub and a cannula projecting distally beyond the hub. A spring is telescoped over the cannula and engages with or into distal portions of the hub. A hub guide projects radially out from the hub. A first wing includes a center sleeve rotationally mounted on the hub and axially movable along the hub when a slot formed in the center sleeve aligns with the hub guide. A second wing has proximal and distal sleeves mounted at opposite ends of the center sleeve. The proximal and distal sleeves each are rotationally mounted relative to the hub and each include slots that enable sliding movement of the hub guide when the slots of the second wing align with the slot of the first wing. The spring propels the cannula and hub into a shielding position when the slots of the wings are rotated into alignment with one another.

Abstract: An apparatus and method are provided for applying adhesive to an outer circumference of a section of tubing. The apparatus includes opposed grippers with concave adhesive transfer areas that can be moved into surrounding relationship with the tubing. Adhesive dispensing passages communicate with the adhesive transfer areas for delivering adhesive to the tubing. Counterbores are at opposed ends of the adhesive transfer areas and communicate with a vacuum source for removing excess adhesive.

Abstract: A device and method for separating heavier and lighter fractions of a fluid sample. The device includes a plurality of constituents comprising a container and a composite element in the container. The composite element is a separator comprising a deformable bellows, a ballast mounted to the lower end of the bellows, and a float is engageable with an upper end of the bellows. A fluid sample is delivered to the container and the device is subjected to centrifugation whereby the centrifugal load causes the ballast to move toward the bottom of the tube and causes an elongation and narrowing of the bellows. The separator then moves down the tube and stabilizes in a position between the separated phases of the fluid sample. Termination of the centrifugal load enables the bellows to return to its original condition in sealing engagement with the walls of the tube.

Abstract: A specimen collection and separation assembly is provided. The assembly includes a tube having closure secured to the open top of the tube. The closure includes a section that is pierceable by a needle cannula for depositing a liquid specimen in the tube. A separator is disposed in the tube below the closure. The separator includes top and bottom ends. Portions of the separator adjacent the top define a resiliently deformable low density sealing plug dimensioned to sealingly engage the interior of the tube. A high density ring is integrally engaged with the seal and extends to the bottom of the separator. The relative densities and dimensions of the seal and the ring are selected to achieve an overall density between densities of the phases of liquid to be separated. The ring causes the seal to elongate in response to forces imposed by a centrifuge. The separator then will move to a position in the tube between the respective phases of the specimen being separated.

Abstract: An automatically shieldable blood collection set is provided. The blood collection set includes a needle assembly having a hub to which a needle cannula is fixedly attached. A safety shield is telescoped relative to the hub and the needle cannula and can be moved from a proximal position where the needle cannula is exposed to a distal position where the needle cannula is safely shielded. A spring is provided between the shield and the hub to propel the shield distally relative to the hub and into surrounding relationship with the needle cannula. A retainer is provided for releasably holding the shield in a proximal ready-to-use condition relative to the hub and the needle cannula. An actuator releases the retainer and enables the shield to be propelled by the spring. A lock may be provided for preventing inadvertent re-exposure of the needle cannula.

Abstract: An automatically shieldable blood collection set is provided. The blood collection set includes a needle assembly having a hub with spaced apart inner and outer tubes. A needle cannula is fixedly attached to the inner tube. A safety shield is telescoped for movement into the space between the inner and outer tubes of the hub. The safety shield can be moved from a proximal position where the needle cannula is exposed to a distal position where the needle cannula is safely shielded. A spring is provided between the shield and the hub to propel the shield distally relative to the hub and into surrounding relationship with the needle cannula. A retainer is provided for releasably holding the shield in a proximal ready-to-use condition relative to the hub and the needle cannula. The retainer may be provided on a fin that extends transversely from the outer tube of the hub. An actuator releases the retainer and enables the shield to be propelled by the spring.

Abstract: A blood collection bag assembly is provided. The assembly includes a flexible blood collection bag, a length of flexible tubing extending from and communicating with the bag and a connector secured to the end of the flexible tubing remote from the bag. The connector includes a needle pierceable resealable closure secured in sealing engagement with the end of the flexible tubing remote from the bag. The connector can be used with a conventional needle holder, such as the type used to collect specimens of blood into an evacuated tube. The blood collection bag assembly has no sharp components, and hence is safe and easy to use. Additionally, the blood collection bag assembly can be used with conventional evacuated tubes to avoid cut and drip techniques for collecting specimens of blood for analysis.

Abstract: A sharps disposal assembly has a recessed unwinder opening in a container lid. The recess has a vertical wall portion integral with a horizontal platform for locating the bottom wall of a tube holder. Another vertical wall portion depending downwardly from the platform has a width congruent with the nose portion of the tube holder.

Abstract: The present invention is a passively shieldable blood collection set. The blood collection set includes a needle cannula, a hub mounted to the needle cannula and a tip guard slidably movable along the needle cannula. The tip guard can be slid into a distal position where the tip of the needle cannula is safely shielded. A collapsible guard drive is mounted to the hub and includes a pair of collapsible leaves extending from the hub to the tip guard. The leaves have a length that enable the tip guard to move into shielding engagement around the tip of the needle cannula, while preventing complete removal of the tip guard from the needle cannula. The leaves are resiliently deformable and can be collapsed onto themselves and onto the hub. The leaves can be retained in their collapsed condition by a packaging cover and subsequently by the grip of a medical practitioner.

Abstract: An automatically shieldable blood collection set is provided. The blood collection set includes a needle assembly having a hub with inner and outer tubes. A needle cannula is fixedly attached to the inner tube. The outer tube is split longitudinal, and a first spring biases the slit into an open orientation. A safety shield is telescoped between the tubes to the hub and the needle cannula and can be moved from a proximal position where the needle cannula is exposed to a distal position where the needle cannula is safely shielded. A second spring is provided between the shield and the hub to propel the shield distally relative to the hub and into surrounding relationship with the needle cannula. However the outer tube can be biased against forces of the first spring to slit and clamp the shield in a fixed position.

Abstract: A resealable barrier closure for a container with an open top and an annular snap ring below the open top. The closure includes a shell having an outer skirt dimensioned to telescope over the open top of the container. The outer skirt has a snap ring for engaging the snap ring on the container. The shell further includes an inner skirt to telescope into the open top of the container. An elastomeric diaphragm is sealingly engaged in the inner skirt. A barrier cup extends across the bottom face of the diaphragm and telescopes upwardly over the inner skin. The barrier cup initially is sealed hermetically to the container and to the plastic shell. The container may be opened by urging the plastic shell upwardly with sufficient force to break the seal between the barrier cup and the container. The container then may be resealed by merely urging the closure back over the open top of the container.

Abstract: An automatically shieldable blood collection set is provided. The blood collection set includes a needle assembly having a hub to which a needle cannula is fixedly attached. A safety shield is telescoped relative to the hub and the needle cannula and can be moved from a first position where the needle cannula is exposed to a second position where the needle cannula is safely shielded. A spring is provided between the shield and the hub to propel at least one of the shield and the hub into the second position. A retainer is provided for releasably holding the shield and the hub in the first position. A resiliently deflectable dorsal fin projects from the hub and through a slot in the shield. The dorsal fin can be deflected to release the retainer and permit the spring to drive the shield end up to the second position. The slot in the shield is configured to lockingly engage the dorsal fin when the shield and the hub are in the second position.

Abstract: The present invention is a collection container assembly comprising a container having a wall space between the inner and outer wall of said tube whereby the external dimensions of the container are substantially the same as a standard-sized blood collection tube but with a reduced internal volume.

Abstract: The present invention is a stopper and shield closure assembly 16 millimeter (mm) fluid collection tube whereby the 16 millimeter tube is compatible with conventional needle holders.

Abstract: A substrate removably attached to a container that can be linked electronically to the operating stations in a laboratory and/or removed and subsequently attached to a document or another container. More particularly, the substrate is a partitioned label with human readable information and electronically readable information.

Abstract: A method and apparatus provides for the establishment of position of readable information applied to a specimen collection container. Preferably, the readable information is provided by way of a scannable bar code label applied to the container. The label may be adhesively applied to the container, and includes a non-adhesive portion which results in that portion of the label protruding from the container. The container is then supported within a container holder. The holder itself has a projection which becomes engaged with the protruding portion of the label. The container holder is agitated to effect movement of the container to place the protruding portion of the label into engagement with the projection, and thereby prevent further movement of the container and establish the position of the readable information contained on the label.