Analytical evaluation of TriVerity, a rapid diagnostic and prognostic host gene expression test performed on the Myrna instrument using RT-LAMP.

We evaluated the analytical performance of the TriVerity test system, a benchtop system for rapid measurement and interpretation of host messenger RNAs (mRNAs) measured quantitatively from PAXgene Blood RNA specimens using the TriVerity cartridge on the Myrna instrument. In approximately 30 minutes, 3 scores are generated from 29 host mRNAs for the likelihood of a bacterial infection, a viral infection, and illness severity (7-day need for ICU-level care), each falling into 1 of 5 interpretation bands (very low, low, moderate, high, and very high). Reproducibility, precision, limit of detection, linearity, interference, and sample and cartridge stability were determined per Clinical Laboratory Standards Institute standards. An operator survey assessed TriVerity's ease of use. Reproducibility demonstrated SDs meeting the acceptance criteria of <5.5 score units. The lowest concentration at which 100% of replicates showed measurable amplification was 1 × 10 IMPORTANCE: The prompt diagnosis of acute infections and sepsis is critical for better patient outcomes. We introduce a groundbreaking messenger RNA-based test, the first of its kind, designed to diagnose the presence of infection and predict illness severity in adult patients with suspected acute infections or sepsis. Several key findings regarding the accuracy and robustness of the test system are presented, which will be relevant to laboratories or acute care settings implementing the test for patient care. Furthermore, these findings may assist clinical researchers in developing analytical trial protocols aimed at the combined evaluation of RNA-based multi-marker tests with both diagnostic and prognostic test characteristics.