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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).