Abstract
Current diagnostics are insufficient for diagnosis and prognosis of acute infections and sepsis. Clinical decisions including prescription and timing of antibiotics, ordering of additional diagnostics and level-of-care decisions rely on understanding etiology and implications of a clinical presentation. Host mRNA signatures can differentiate infectious from noninfectious etiologies, bacterial from viral infections, and predict 30-day mortality. The 29-host-mRNA blood-based InSepTM test (Inflammatix, Burlingame, CA, formerly known as HostDxTM Sepsis) combines machine learning algorithms with a rapid point-of-care platform with less than 30 min turnaround time to enable rapid diagnosis of acute infections and sepsis, as well as prediction of disease severity. A scientific advisory panel including emergency medicine, infectious disease, intensive care and clinical pathology physicians discussed technical and clinical requirements in preparation of successful introduction of InSep into the market. Topics included intended use; patient populations of greatest need; patient journey and sample flow in the emergency department (ED) and beyond; clinical and biomarker-based decision algorithms; performance characteristics for clinical utility; assay and instrument requirements; and result readouts. The panel identified clear demand for a solution like InSep, requirements regarding test performance and interpretability, and a need for focused medical education due to the innovative but complex nature of the result readout. Innovative diagnostic solutions such as the InSep test could improve management of patients with suspected acute infections and sepsis in the ED, thereby lessening the overall burden of these conditions on patients and the healthcare system.
Highlights
As the Intended Use is a critical component of the instructions for use defining the use case for a test, advisors were given the proposed Intended Use statement: “InSep is intended to assist in the evaluation of any patient suspected of an acute infection and to support clinician decisions regarding whether or not to treat with antibiotics, selection of other downstream diagnostics, and level of care”
It could be used at emergency department (ED) admission, during ward “sepsis alerts”, and/or when making decision regarding intensive care unit (ICU) status changes
The panelists agreed that as current diagnostic offerings are insufficient for the rapid diagnosis of acute infections and sepsis, the InSep test with its three independent readouts for the likelihoods of bacterial and viral infections and severity of the condition would provide actionable results that have the potential to guide decision making
Summary
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