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Table 1 Clinical impact categories and their predefined criteria

From: Clinical impact of a metagenomic microbial plasma cell-free DNA next-generation sequencing assay on treatment decisions: a single-center retrospective study

Category

Definition

Positive

Test result led to a new diagnosis when conventional tests were negative

Test result confirmed clinical diagnosis

Test result led to an earlier diagnosis

Test result negated invasive or costly procedures or tests

Test result helped reduce length of hospital stay

Test result led to the initiation of appropriate antimicrobial therapy

Test result led to de-escalation or discontinuation of antimicrobial therapies

Negative

Test result led to unnecessary antimicrobial treatment

Test result led to unnecessary diagnostic investigation or procedures

Test result led to an unnecessarily prolonged hospital stay

Uncertain or No impact

Test result did not change any clinical management or unable to determine the clinical impact

  1. Test Result—result of microbial cell-free DNA assay; conventional tests—standard serological, microbiological, and molecular, histopathological and biochemical results