Abstract: A blood sampling transfer device that is adapted to receive a blood sample having a cellular portion and a plasma portion is disclosed. The blood sampling transfer device is able to separate the plasma portion from the cellular portion. After separation, the blood sampling transfer device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The blood sampling transfer device also provides a closed sampling and transfer system that reduces the exposure of a blood sample and provides fast mixing of a blood sample with a sample stabilizer. The blood sampling transfer device is engageable with a blood testing device for closed transfer of a portion of the plasma portion from the blood sampling transfer device to the blood testing device. The blood testing device is adapted to receive the plasma portion to analyze the blood sample and obtain test results.

Abstract: A needle assembly is disclosed. The needle assembly includes a housing having a flash chamber, and having a distal end and a proximal end engageable with a specimen collection container. The assembly includes a cannula having a patient end, a non-patient end, and a sidewall extending therebetween defining a cannula interior. The patient end of the cannula projects at least partially from the distal end of the housing, and the cannula interior is in fluid communication with the flash chamber. The assembly further includes a shield restrainably engaged with a portion of the housing and axially transitionable over the patient cannula from a retracted position in which the patient end is exposed, to an extended position in which the patient end is shielded by at least a portion of the shield, wherein at least a portion of the flash chamber is visible in the retracted position.

Abstract: A closure for use with a specimen collection container is disclosed. The closure includes a base portion having a first end adapted for engagement with an open end of the specimen collection container, and a second end adapted for receiving a portion of a syringe assembly therein. The closure also includes a luer fitting connected to the base portion and having at least one channel for venting an interior of the specimen collection container to atmosphere during introduction of a fluid specimen from the syringe assembly into the specimen collection container. The closure further includes a shielding portion connected to the base portion and adapted to transition from an open position in which fluid communication is established between the first end and the second end through the luer fitting, to a closed position in which the luer fitting is fully shielded by the shielding portion.

Abstract: A closure for use with a specimen collection container is disclosed. The closure includes a base portion having a first end adapted for engagement with an open end of the specimen collection container, and a second end adapted for receiving a portion of a syringe assembly therein. The closure also includes a luer fitting connected to the base portion and having at least one channel for venting an interior of the specimen collection container to atmosphere during introduction of a fluid specimen from the syringe assembly into the specimen collection container. The closure further includes a shielding portion connected to the base portion and adapted to transition from an open position in which fluid communication is established between the first end and the second end through the luer fitting, to a closed position in which the luer fitting is fully shielded by the shielding portion.

Abstract: A needle assembly is disclosed. The needle assembly includes a housing having a flash chamber, and having a distal end and a proximal end engageable with a specimen collection container. The assembly includes a cannula having a patient end, a non-patient end, and a sidewall extending therebetween defining a cannula interior. The patient end of the cannula projects at least partially from the distal end of the housing, and the cannula interior is in fluid communication with the flash chamber. The assembly further includes a shield restrainably engaged with a portion of the housing and axially transitionable over the patient cannula from a retracted position in which the patient end is exposed, to an extended position in which the patient end is shielded by at least a portion of the shield, wherein at least a portion of the flash chamber is visible in the retracted position.

Abstract: A container for storing a biological sample is disclosed. The container includes a first chamber having a sidewall extending between an open end and a closed end, defining a first chamber interior adapted to receive a sample holder therein. The container also includes a second chamber having a sidewall extending between an open end and a closed end, defining a second chamber interior adapted to subsequently receive the sample holder therein. The second chamber interior is in fluid isolation from the first chamber interior. A removable closure encloses at least one of the open end of the first chamber and the open end of the second chamber while the sample holder is disposed within one of the first chamber interior and the second chamber interior. A first fluid may be disposed within the first chamber interior, and a second different fluid may be disposed within the second chamber interior.

Abstract: A mechanical separator for separating a fluid sample into first and second phases is disclosed. The mechanical separator includes a float having a first portion and a second portion, a ballast circumferentially disposed about a section of the float, and a deformable bellows defining an open passageway extending between a first end and a second end. The ballast is longitudinally moveable with respect to the float and engaged with the deformable bellows between the first end and the second end. At least a portion of the float is transitionable from a restraint position to a sealed position through the first end of the bellows. The first portion of the float can be positioned within the interior of the deformable bellows in the restraint position, and the first portion of the float can be positioned at an exterior location longitudinally displaced from the deformable bellows in the sealed position.

Abstract: A container for storing a biological sample is disclosed. The container includes a housing having a closed end, an open end, and a sidewall extending therebetween defining a container interior. The container has a removable closure for enclosing the open end of the housing and a sample holder for housing a biological sample detachably connected to the closure and insertable within the container interior. A port is disposed within the closure adjacent the sample holder to allow fluid to pass therethrough into the container interior. An injection device for engaging the port may also be provided. A first fluid may be initially provided within the container interior and a second fluid may be subsequently injected by the injection device through the port into the container interior.

Abstract: A blood separation and testing system for a blood sample is disclosed. The blood separation and testing system includes a blood sampling transfer device adapted to receive a blood sample, a blood separation device, and a blood testing device. The blood separation device is adapted to receive a portion of the blood sampling transfer device such that with the blood sampling transfer device received within the blood separation device and a rotational force applied to the blood sampling transfer device, a plasma portion of the blood sample is separated from a cellular portion of the blood sample. The blood testing device is adapted to receive a portion of the blood sampling transfer device to analyze the plasma portion of the blood sample and obtain test results.

Abstract: A specimen transfer device adapted to receive a blood sample is disclosed. The specimen transfer device includes a housing and an actuation member. A deformable material is disposed within the housing and is deformable from an initial position in which the material is adapted to hold the sample to a deformed position in which at least a portion of the sample is released from the material. A viscoelastic member is disposed within the housing between the material and the housing and between the material and the actuation member. The viscoelastic member is engaged with the actuation member and the material such that movement of the actuation member from a first position to a second position deforms the material from the initial position to the deformed position.

Abstract: A container for storing a biological sample for molecular diagnostic testing and/or histological testing is provided. The container includes a first chamber for receiving a sample holder therein, a second chamber, and a closure for enclosing the container. A breakable membrane, such as a piercable foil, extends within the container and separates the two chambers. When the breakable membrane is broken, fluid can pass between the first and second chambers. The membrane may be broken through an activator on the closure, such as a depressible member or a rotatable carrier, causing the sample holder to break through the membrane.

Abstract: A needle assembly is disclosed. The needle assembly includes a housing having a flash chamber, and having a distal end and a proximal end engageable with a specimen collection container. The assembly includes a cannula having a patient end, a non-patient end, and a sidewall extending therebetween defining a cannula interior. The patient end of the cannula projects at least partially from the distal end of the housing, and the cannula interior is in fluid communication with the flash chamber. The assembly further includes a shield restrainably engaged with a portion of the housing and axially transitionable over the patient cannula from a retracted position in which the patient end is exposed, to an extended position in which the patient end is shielded by at least a portion of the shield, wherein at least a portion of the flash chamber is visible in the retracted position.

Abstract: Disclosed is a fluid collection device wherein multiple, individual samples of fluid can be collected simultaneously. The device includes a chamber and an adapter which substantially and simultaneously distributes the blood to individual chambers with chamber specific additives. Also included is a system for using the blood collection device, preferably within a diagnostic testing laboratory.

Abstract: A mechanical separator for separating a fluid sample into first and second phases is disclosed. The mechanical separator includes a float having a first portion and a second portion, a ballast circumferentially disposed about a section of the float, and a deformable bellows defining an open passageway extending between a first end and a second end. The ballast is longitudinally moveable with respect to the float and engaged with the deformable bellows between the first end and the second end. At least a portion of the float is transitionable from a restraint position to a sealed position through the first end of the bellows. The first portion of the float can be positioned within the interior of the deformable bellows in the restraint position, and the first portion of the float can be positioned at an exterior location longitudinally displaced from the deformable bellows in the sealed position.

Abstract: A specimen transfer device adapted to receive a blood sample is disclosed. The specimen transfer device includes a housing and an actuation member. A deformable material is disposed within the housing and is deformable from an initial position in which the material is adapted to hold the sample to a deformed position in which at least a portion of the sample is released from the material. A viscoelastic member is disposed within the housing between the material and the housing and between the material and the actuation member. The viscoelastic member is engaged with the actuation member and the material such that movement of the actuation member from a first position to a second position deforms the material from the initial position to the deformed position.

Abstract: A needle assembly is disclosed. The needle assembly includes a housing having a flash chamber, and having a distal end and a proximal end engageable with a specimen collection container. The assembly includes a cannula having a patient end, a non-patient end, and a sidewall extending therebetween defining a cannula interior. The patient end of the cannula projects at least partially from the distal end of the housing, and the cannula interior is in fluid communication with the flash chamber. The assembly further includes a shield restrainably engaged with a portion of the housing and axially transitionable over the patient cannula from a retracted position in which the patient end is exposed, to an extended position in which the patient end is shielded by at least a portion of the shield, wherein at least a portion of the flash chamber is visible in the retracted position.

Abstract: A container for storing a biological sample for molecular diagnostic testing and/or histological testing is provided. The container includes a first chamber for receiving a sample holder therein, a second chamber, and a closure for enclosing the container. A breakable membrane, such as a piercable foil, extends within the container and separates the two chambers. When the breakable membrane is broken, fluid can pass between the first and second chambers. The membrane may be broken through an activator on the closure, such as a depressible member or a rotatable carrier, causing the sample holder to break through the membrane.

Abstract: A shielding needle assembly is provided with a hub having a needle cannula with a puncture tip extending from a forward end thereof, and a shield member in telescoping association with the hub. A drive member biases the hub and the shield member away from each other for relative telescopic movement between a first position in which the puncture tip extends from a forward end of the shield member, and a second position in which the puncture tip is encompassed within the shield member. A pivoting lever maintains the hub and the shield member in the first position against the bias of the drive member with the needle cannula exposed for use. The lever is pivotable during contact with a patient's skin surface such as during venipuncture, thereby releasing the hub and the shield member from the first position and permitting the drive member to bias the hub and the shield member toward the second position.

Abstract: A blood collection assembly includes a housing and a cannula extending distally from the housing including a patient end, and a cannula shield removably engaged with a portion of the housing. The cannula shield is capable of shielding at least the patient end of the cannula, and includes a safety shield engagement. The assembly includes a pivoting safety shield engaged with a portion of the housing, which is transitionable from a retracted position in which the patient end of the cannula is exposed, to an extended position in which the patient end of the cannula is shielded by at least a portion of the safety shield. The safety shield includes at least one locking tab releasably engageable with the safety shield engagement, wherein the locking tab is fixedly engageable with a portion of the housing in the extended position.

Abstract: A blood separation and testing system for a blood sample is disclosed. The blood separation and testing system includes a blood sampling transfer device adapted to receive a blood sample, a blood separation device, and a blood testing device. The blood separation device is adapted to receive a portion of the blood sampling transfer device such that with the blood sampling transfer device received within the blood separation device and a rotational force applied to the blood sampling transfer device, a plasma portion of the blood sample is separated from a cellular portion of the blood sample. The blood testing device is adapted to receive a portion of the blood sampling transfer device to analyze the plasma portion of the blood sample and obtain test results.