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DiaSys Procalcitonin FS assay is a particle enhanced immunoturbidimetric test intended for the quantitative in vitro determination of procalcitonin (PCT) in human serum and lithium heparin plasma on automated Abbott ARCHITECT c8000 analyzer. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of Intensive Care Unit (ICU) admission for progression to severe sepsis and septic shock. The TruCal Procalcitonin Calibrator Set is intended for in vitro use for calibration of the DiaSys Procalcitonin FS assay. TruLab Procalcitonin Bi-Level Controls are an assayed quality control material for monitoring the performance of quantitative in vitro determination of Procalcitonin (PCT) for the DiaSys Procalcitonin FS assay. For in vitro diagnostic use only.

The DiaSys Procalcitonin FS assay is a particle enhanced turbidimetric immunoassay (PETIA) test for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and lithium heparin plasma on automated photometric systems. The test utilizes anti-human PCT polyclonal antibodies (goat) covalently bound to polystyrene particles. PCT in the sample binds to the anti-PCT antibodies on the particles and causes agglutination. The degree of the turbidity caused by agglutination is optically measured at 660 nm by the automated photometric system and is proportional to the amount of PCT in the sample. DiaSys Procalcitonin FS Reagent specifies settings for an automated photometric analyzer, the Abbott ARCHITECT c8000. The DiaSys TruCal Procalcitonin Calibrator Set is provided in 6 levels, traceable to a commercial assay for use in the calibration of the DiaSys Procalcitonin FS assay. The DiaSys TruLab Procalcitonin Bi-Level Controls, Levels 1 (low) and 2 (high) are intended for use as quality control for the DiaSys Procalcitonin FS assay. DiaSys PCT Calibrators and Bi-Level Controls are ready-to-use, stable, aqueous solutions containing recombinant human full-length PCT and biological additives from bovine origin.

The Cytovale IntelliSep test is a semi-quantitative test that assesses cellular host response via deformability cytometry of leukocyte biophysical properties and is intended for use in conjunction with clinical assessments and laboratory findings to aid in the early detection of sepsis with organ dysfunction manifesting within the first 3 days after testing. It is indicated for use in adult patients with signs and symptoms of infection who present to the Emergency Department. The test is performed on an EDTA anticoagulated whole blood sample. The IntelliSep test generates an IntelliSep Index value that falls within one of three discrete interpretation bands based on the probability of sepsis with organ dysfunction manifesting within the first three days after testing. The IntelliSep test represents the probability of the clinical syndrome of sepsis and is intended to be used alongside other clinical information and clinical judgement. It does not identify the causative agent of infection and should not be used as the sole basis to determine the presence of sepsis. The IntelliSep test is intended for in vitro diagnostic use.

The Cytovale IntelliSep test is a short turn-around time (STAT) test, producing results in 10 minutes or less, to aid in the early detection of sepsis with organ dysfunction manifesting within the first 3 days after testing. It assesses the state of immune activation in patients with signs and symptoms of infection who present in the Emergency Department (ED). The IntelliSep test is run on the Cytovale System, a laboratory benchtop analyzer depicted in Figure 1 and Figure 2. To run a test, the laboratory operator transfers 100 uL of whole blood into the sample preparation tube which is then placed into the Cytovale System. The system automatically lyses red blood cells, and washes the purified leukocytes in a diluent, producing a total volume of approximately 1mL of prepared sample, which the operator then transfers to the IntelliSep cartridge for analysis on the Cytovale System. A microfluidic deformability cytometry technique is used to measure the biophysical properties of thousands of individual leukocytes in rapid succession. These properties have been shown to differ in quiescent white blood cell populations when compared to those in septic patients, enabling rapid assessment of the host response and the likelihood of having sepsis with organ dysfunction manifesting within the first 3 days after testing. Based on these measurements, the test provides a single score, the IntelliSep Index (ISI), ranging from 0.1-10.0, stratified into three discrete interpretation bands (Band 2, Band 3) of increasing sepsis likelihood.

The TriVerity test is an automated ve in vitro diagnostic test that measures the relative expression levels of host response genes in RNA isolated from whole blood collected in the PAXgene Blood RNA tube using reverse transcription loop-mediated isothermal amplification (RT-LAMP) on the Myrna instrument. The TriVerity test is indicated for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial infections, viral infections, and non-infectious illness, as well as to determine the likelihood of 7day need for mechanical ventilation, vasopressors, and/or renal replacement with suspected acute infection or suspected sepsis presenting to the emergency department. The test generates three scores that each fall within one of five discrete interpretation bands based on the increasing likelihood of 1) bacterial infection, 2) viral infection, and 3) severe illness, as defined by the need for mechanical ventilation, vasopressors, and/ or renal replacement therapy (RRT) within seven days.

The TriVerity test is an in vitro diagnostic test for simultaneous amplification and detection of 29 informative host response RNA transcripts and 3 housekeeping transcripts (listed in measurands) using total RNA extracted from human blood. The test has been designed, manufactured, and validated for use on the Myrna instrument. The TriVerity test is performed with a TriVerity cartridge, a single-use, disposable, multi-chambered fluidic cartridge that runs on the Myrna instrument. All processing steps are automated and occur within a TriVerity cartridge, including sample extraction/purification and qRT-LAMP for the detection and relative quantification of the 29 informative host response RNA transcripts and 3 housekeeping transcripts (listed in measurands). All cartridge steps in this process, following the addition of the sample, are fully automated and completely integrated. In approximately 30 minutes, the test generates three scores that each fall within one of five discrete interpretation bands based on the increasing likelihood of - 1) bacterial infection, - 2) viral infection, and - 3) severe illness, as defined by the need for mechanical ventilation, vasopressors, and/or renal replacement therapy (RRT) within seven days. The specimen used for the TriVerity test is a sample of whole blood collected by venipuncture using the PAXgene blood collection tubes within the PAXgene Blood RNA System (K042613). The cartridge contains all the necessary reagents to perform RNA isolation and subsequent amplification from the sample. The TriVerity test quantifies the amount of each transcript in the sample based on the detection of fluorescence by the Myrna instrument. The cartridge includes the reagents for reverse transcription and LAMP. All 32 transcripts (and two in cartridge controls) are amplified and quantified. These values are input to two fixed classifiers which output the three separate scores, each with five discrete interpretation bands. The bands reflect monotonically increasing likelihood of bacterial infection, viral infection, and severe illness, as defined by the need for mechanical ventilation, vasopressors, and/or renal replacement therapy (RRT) within seven days.

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.

The SeptiCyte RAPID test is a gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood collected in PAXgene Blood RNA Tubes, K2-EDTA blood tubes, or K3-EDTA blood tubes. The SeptiCyte RAPID test is used in conjunction with clinical assessments and other laboratory findings as an aid to differentiate infection-positive (sepsis) from infection-negative systemic inflammation in patients suspected of sepsis on their first day of ICU admission. The SeptiCyte RAPID test generates a score (SeptiScore) that falls within one of four discrete Interpretation Bands based on the increasing likelihood of infection-positive systemic inflammation. SeptiCyte RAPID is intended for in-vitro diagnostic use on the Biocartis Idylla System.

The SeptiCyte RAPID test is a gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood collected in PAXgene Blood RNA Tubes, K2-EDTA blood tubes, or K3-EDTA blood tubes. The SeptiCyte RAPID test is used in conjunction with clinical assessments and other laboratory findings as an aid to differentiate infection-positive (sepsis) from infection-negative systemic inflammation in patients suspected of sepsis on their first day of ICU admission. The SeptiCyte RAPID test generates a score (SeptiScore) that falls within one of four discrete Interpretation Bands based on the increasing likelihood of infection-positive systemic inflammation. SeptiCyte RAPID is intended for in-vitro diagnostic use on the Biocartis Idylla System.

The MeMed BV test is an automated semi-quantitative immunoassay that measures three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatic serum and venous whole blood samples and is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. MeMed BV is indicated for use in patients presenting to the emergency department or urgent care center and with samples collected at hospital admission from patients with suspected acute bacterial or viral infection, who have had symptoms for less than seven days. The MeMed BV test generates a numeric score that falls within discrete interpretation bins based on the increasing likelihood of bacterial infection.

The MeMed BV® ("BV test" or the "test") is an In-Vitro-Diagnostic device that measures in parallel the blood concentrations of TRAIL, IP-10 and CRP. The test consists of an automated analyzer with built-in hardware and software that conduct chemiluminescence based analyte measurements of patient serum and venous whole blood samples and their computational integration (MeMed Key®), and a disposable cartridge that contains the reagents and controls needed to detect the analytes of interest (MeMed BV® cartridge). The test generates an answer to each sample, with a test run time of approximately 15 minutes.

The Access PCT assay is a paramagnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of Intensive Care Unit (ICU) admission for progression to severe sepsis and septic shock.

The Access PCT assay is a paramaqnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of Intensive Care Unit (ICU) admission for progression to severe sepsis and septic shock. A description of the reagent pack is provided below. - R1a: Dynabeads* paramagnetic particles coated with mouse anti-. human Procalcitonin monoclonal antibody in a TRIS buffer with surfactant, protein (bovine), ≤ 0.1% sodium azide, and 0.1% ProClin**300 - R1b: 0.10 N Sodium Hydroxide ● - R1c: MOPS Buffer with surfactant and protein (bovine, murine), ≤ ● 0.1 % sodium azide, and 0.1% ProClin 300 - R1d: Rat anti-Procalcitonin recombinant alkaline phosphatase . coniugate in a MOPS buffer with surfactant and protein (bovine, murine, recombinant). ≤ 0.1% sodium azide, and 0.1% ProClin 300

The MeMed BV test is an automated semi-quantitative immunoassay that measures three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples and is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. The MeMed BV is indicated for use in patients presenting to the emergency department or urgent care center and with samples collected at hospital admission from patients with suspected acute bacterial or viral infection, who have had symptoms for less than seven days. The MeMed BV test generates a numeric score that falls within discrete interpretation bins based on the increasing likelihood of bacterial infection.

The Med BV® ("BV Test" or the "Test") is an In-Vitro-Diagnostic device that measures in parallel the blood concentrations of TRAIL, IP-10 and CRP. The Test consists of an automated analyzer with built-in hardware and software that conduct chemiluminescencebased analyte measurements of patient serum samples and their computational integration (MeMed Key®), and a disposable cartridge that contains the reagents and controls needed to detect the analytes of interest (MeMed BV® cartridge). The Test generates an answer to each sample, with a test run time of approximately 15 minutes.

The Cytovale IntelliSep test is a semi-quantitative test that assesses cellular host response via deformability cytometry of leukocyte biophysical properties and is intended for use in conjunction with clinical assessments and laboratory findings to aid in the early detection of sepsis with organ dysfunction manifesting within the first 3 days after testing. It is indicated for use in adult patients with signs and symptoms of infection who present to the Emergency Department. The test is performed on an EDTA anticoagulated whole blood sample. The IntelliSep test generates an IntelliSep Index value that falls within one of three discrete interpretation bands based on the probability of sepsis with organ dysfunction manifesting within the first three days after testing. The IntelliSep test represents the probability of the clinical syndrome of sepsis and is intended to be used alongside other clinical information and clinical judgement. It does not identify the causative agent of infection and should not be used as the sole basis to determine the presence of sepsis. The IntelliSep test is intended for in vitro diagnostic use.

The Cytovale IntelliSep test is a short turn-around time (STAT) test, producing results in 10 minutes or less, to aid in the early identification of patients at risk for having or developing sepsis within three (3) days of testing. It assesses the state of immune activation in patients with clinical suspicion of infection who present in the Emergency Department (ED). The IntelliSep test is run on the Cytovale System, a laboratory benchtop analyzer depicted in Figure 1. The Cytovale System is a closed system benchtop analyzer, comprised of three modules: Sample Preparation Module, Cell Imaging Module, and Imaging Analysis Module. To run a test, the laboratory operator transfers 100 µL of whole blood into the sample preparation tube which is then placed into the Cytovale System. The system automatically lyses red blood cells, and washes the purified leukocytes in a diluent, producing a total volume of approximately 1mL of prepared sample, which the operator then transfers to the IntelliSep cartridge for analysis on the Cytovale System. A microfluidic deformability cytometry technique is used to measure the biophysical properties of thousands of individual leukocytes in rapid succession. These properties have been shown to differ in quiescent white blood cell populations when compared to those in septic patients, enabling for rapid assessment of the host response and the likelihood of having or developing sepsis. Based on these measurements, the test provides a single score, the IntelliSep Index (ISI), ranging from 0.1-10.0, stratified into three discrete interpretation bands (Band 1, Band 2, Band 3) of sepsis likelihood.

The Dimension® EXL™ LOCI® BRAHMS Procalcitonin (PCT) assay is an in vitro diagnostic test for the quantitative measurement of procalcitonin in human serum and plasma (lithium heparin, K2EDTA, and K3EDTA) using the Dimension® EXL™ integrated chemistry system with LOCI® Module. The Dimension EXL LOCI® BRAHMS PCT assay is intended for use in conjunction with other laboratory findings and clinical assessments, as an aid in: · The risk assessment of critically ill patients on their first day of Intensive Care Unit (ICU) admission for progression to severe sepsis and septic shock. • Assessing the cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the ICU or when obtained in the emergency department or other medical wards prior to ICU admission using percentage change in PCT levels over time. · Decision making on antibiotic therapy for patients with suspected or confirmed lower respiratory tract infections (LRTI) - defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD) - in an inpatient setting or an emergency department. · Decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis.

The Dimension EXL LOCI BRAHMS PCT assay is a homogeneous sandwich chemiluminescent immunoassay based on LOCI technology. The LOCI reagents include two synthetic bead reagents and one biotinylated anti-procalcitonin (anti-PCT) monoclonal antibody. The first bead reagent (Sensibeads) is coated with streptavidin and contains photosensitizer dye. The second bead reagent (Chemibeads) is coated with two anti-PCT monoclonal antibodies and contains chemiluminescent dye. Sample is incubated with biotinylated antibody and Chemibeads to form bead-PCT-biotinylated antibody sandwiches. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination of the complex at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is a direct function of the procalcitonin (PCT) concentration in the sample.