TriVerity

TriVerity is an automated, semi-quantitative in vitro diagnostic test that measures the expression levels of 29 host response genes in RNA isolated from whole blood using reverse transcription loop-mediated isothermal amplification (RT-LAMP). It is indicated to aid in differentiating bacterial infections, viral infections, and non-infectious illness, and to determine the likelihood of needing mechanical ventilation, vasopressors, or renal replacement therapy within seven days in adult patients presenting to the emergency department with suspected acute infection or sepsis.

TriVerity uses RT-LAMP amplification and detection with an intercalating fluorescent dye, measuring 29 host response genes plus 3 housekeeping genes on the Myrna instrument, whereas the predicate SeptiCyte RAPID uses reverse transcription polymerase chain reaction (RT-qPCR) with hydrolysis probe chemistry to measure only 2 mRNA biomarkers. TriVerity generates three separate scores (bacterial, viral, severity), each with five discrete interpretation bands, whereas SeptiCyte RAPID generates a single SeptiScore with four bands. Both use PAXgene Blood RNA tubes and automated specimen processing.

CLSI EP05-A3, EP06, EP07, EP17-A2, EP25-A, and EP37 for analytical validation; ASTM D4169-23 and F2825-18 for shipping stability testing; and FDA guidance on software validation for medical devices.

TriVerity is substantially equivalent to SeptiCyte RAPID because both are quantitative gene expression assays measuring host response markers from whole blood in PAXgene tubes to aid in diagnosing infection and assessing sepsis severity in emergency department patients. Although TriVerity uses RT-LAMP instead of RT-qPCR and measures more genes with additional clinical endpoints (prognostic severity prediction), the analytical performance is comparable or superior: bacterial AUROC 0.83 vs. predicate performance, viral AUROC 0.91, and severity AUROC 0.78. Both employ similar workflow automation, specimen types, and clinical intent to support infection and sepsis assessment as adjuncts to clinical judgment. The expanded gene panel and additional severity score do not raise different safety or effectiveness questions, as they serve the same regulatory classification (21 CFR 866.3215) and use principles of gene expression measurement established by the predicate.