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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 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 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 the PAXgene ® Blood RNA Tube. The SeptiCyte ® RAPID test is used in conjunction with clinical assessments and other laboratory findings as an aid to differentiate infection-positive (sepsis) from infectionnegative 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 infectionpositive systemic inflammation. SeptiCyte ® RAPID is intended for in-vitro diagnostic use on the Biocartis IdyllaTM System.

SeptiCyte RAPID is an in vitro diagnostic test for simultaneous amplification and detection of two RNA transcripts (PLA2G7 and PLAC8) using total RNA extracted from human blood. The test has been designed, manufactured, and validated for use on the Biocartis Idylla real-time PCR system. The SeptiCyte RAPID test is performed with an Idylla Cartridge, a single-use, disposable, multi-chambered fluidic cartridge that runs on the Biocartis Idylla System. In an automated fashion, all reaction steps take place within the cartridge, including sample extraction/purification, RT-qPCR for the detection and relative quantification of the two human mRNA targets PLAC8. PLA2G7. Test results (measured Cg values and calculated SeptiScore) are available in about 65 minutes. The specimen used for the SeptiCyte RAPID is a sample of whole blood collected in a PAXgene blood RNA tube (FDA 510k number K042613). The cartridge contains all of the necessary reagents to perform RNA isolation from the sample. SeptiCyte RAPID uses quantitative, real-time determination of the amount of each transcript in the sample based on the detection of fluorescence by the Biocartis Idylla qPCR instrument function. The cartridge includes the reagents for reverse transcription and PCR. Transcripts PLAC8 and PLA2G7 are amplified and quantified. These values are combined to produce the SeptiScore, which is interpreted and categorized into four discrete bands, which are associated with a sequentially higher likelihood of sepsis.

SeptiCyte™ LAB 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 the PAXgene™ Blood RNA Tube. SeptiCyte™ LAB is used in conjunction with clinical assessments and other laboratory findings as an aid to differentiate infection-positive (sepsis) from infection-negative systemic in patients suspected of sepsis on their first day of ICU admission. The 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™ LAB is in-vitro diagnostic use.

SeptiCyte™ LAB is an in vitro diagnostic test to be used when prescribed by a clinician in professional settings such as central hospital laboratories. SeptiCyte™ LAB is a reverse transcription quantitative polymerase chain reaction (RT-gPCR)-based laboratory test that quantifies the relative expression levels of four host response genes (CEACAM4, LAMP1, PLA2G7, PLAC8) using RNA extracted from the whole blood of critically ill patients suspected of sepsis. It is a kit developed specifically for the Applied Biosystems® 7500 Fast Dx Real-Time PCR System. SeptiCyte™ LAB serves as an indicator of the host response to infection in systemically inflamed patients by measuring the expression of specific genes with roles in immune function, and infection. More specifically it aids in differentiating infection-positive systemic inflammation (IPSI) from infection-negative systemic inflammation (INSI). SeptiCyte™ LAB measures the relative expression levels of the four genes by threshold cycle (Ct) in RT-qPCR. Ct values are linearly combined in a SeptiSCORE™ ranging from 0 to 10 by SeptiCyte™ Analysis software. The higher the SeptiSCORE™ value, the greater the likelihood of IPSI; the lower the SeptiSCORE™, the less likely the condition is caused by infection (INSI).