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Results did not guide care, and 19.6% of bacterial results fell in the moderate band, with a likelihood ratio of 0.9."}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["summary","account"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"systems[].autonomy_permissions":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].component_role":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].deployment_configuration":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].inputs_outputs":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].model_name":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].model_version":{"state":"value_present","value":{"kind":"record_fields","fields":{"model_version":"IMX-BVN-4 and IMX-SEV-4 classifiers"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["model_version"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"systems[].product_name":{"state":"value_present","value":{"kind":"record_fields","fields":{"system":"TriVerity"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["system"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"systems[].provider":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"taxonomy_crosswalks[]":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"title":{"state":"value_present","value":{"kind":"record_fields","fields":{"title":"FDA found that TriVerity sorted most emergency patients with suspected infection into actionable bands for bacterial infection and severe illness","headline":"*TriVerity* sorted emergency patients by infection type and severity"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["title","headline"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"version":{"state":"value_present","value":{"kind":"identifiers","identifiers":["391d1ea20940c40c7272202156a35e9cf307d9ce467ca5499fee3c6d19a527c5"],"role":"SHA-256 of the complete public record and its assessments"},"provenance":{"kind":"curatorial","basis":"SHA-256 of the public record, its assessments, and its displayed answers and notes, excluding its own identifier and the derived coverage summary.","record_fields":[],"source_refs":[]},"review_state":"record_mapped","coverage":"complete"},"workflow":{"state":"value_present","value":{"kind":"record_fields","fields":{"account":"Inflammatix makes TriVerity, a blood test that measures 29 host-response genes on its Myrna instrument. Two fixed classifiers turn the gene expression into scores for bacterial infection, viral infection and severe illness within seven days. The non-interventional SEPSIS-SHIELD study ran at 22 emergency departments and academic hospitals in the United States and Europe. Physicians blinded to the test adjudicated each patient's diagnosis. The diagnostic analysis covered 1,222 patients, 933 of them from banked frozen samples. FDA reviewers report that 80.4% of bacterial results fell in the four actionable bands. Of 1,120 patients, 10.9% needed mechanical ventilation, vasopressors or renal replacement therapy within seven days. That risk was 58.1% in the Very High band and 2.7% in the Very Low band. FDA cleared the test on 10 January 2025. Results did not guide care, and 19.6% of bacterial results fell in the moderate band, with a likelihood ratio of 0.9.","replication":{"produced_by":["Blood was drawn into a PAXgene Blood RNA tube and run on the Myrna instrument.","Cut-offs between the interpretation bands were set before the clinical trial on 399 samples from independent sites."],"must_hold":["The patient is an adult in the emergency department with suspected acute infection or suspected sepsis.","Clinicians use the result with clinical assessments and other laboratory findings."],"echoes":[]}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["account","replication"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"}},"summary":{"total":91,"addressed":91,"known":29,"reviewed":2,"reviewed_complete":2,"reviewed_partial":0,"record_mapped":27,"review_not_assessed":62,"not_assessed":0,"complete":false,"by_state":{"value_present":29,"not_reported":0,"unresolved":62,"not_assessed":0,"not_applicable":0,"withheld":0,"source_unavailable":0}}},"presentation_version":"9a8a53a5f38400f2a963045fb5b3ea207273daa1f8c375376468e8f459354d77"}