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The IVD CAPSULE PSP is a single-use, rapid in vitro diagnostic immunofluorescence assay for the semi-quantitative determination of the concentration of pancreatic stone protein (PSP) in human K2-EDTA (arterial and K3-EDTA (venous) anticoagulated whole blood. The IVD CAPSULE PSP is to be used on the abioSCOPE in vitro diagnostic analyzer. This diagnostic test is used in conjunction with other clinical assessments and laboratory findings to aid in the early detection of sepsis manifesting within the first 3 days after testing. IVD CAPSULE PSP generates PSP values that fall within one of three discrete Interpretation bands based on increasing likelihood of sepsis. The test is intended for professional use in clinical laboratory settings. It is indicated for use in adult patients at high risk of sepsis presenting to intensive care units (ICUs).

The IVD CAPSULE PSP is a single-use, semi-quantitative immunofluorescence assay used to determine the concentration of the pancreatic stone protein (PSP) in a human whole blood sample. The test kit contains the following components: Capsule, Special pipette (abioPIPETTE), Vial containing a detection reagent (abioMIX), Desiccant bag. The main component is the capsule, a high impact polystyrene plastic cartridge. The capsule allows dispensing the blood-abioMIX solution onto the loading port with a membrane separator. A second membrane drives the sample by capillary force to nanofluidic biosensors containing a read-out area where PSP is captured by specific antibodies and fluorescently detected. The concentration of captured PSP is proportional to the fluorescence generated by the fluorophore conjugated to the detection antibody. The capsule also contains an RFID tag programmed with biosensor configuration and lot-specific information. The abioSCOPE is a tabletop diagnostic device that measures analytes in biological samples using test-specific capsules (IVD CAPSULE). It is operated through a high-resolution touchscreen. It is composed of a fully automated fluorescence microscope and a tray for the IVD CAPSULE. The abioSCOPE uses a laser to excite molecular complexes inside the biosensors, leading to fluorescence emission. The abioSCOPE then calculates the concentration of the analyte.