TABLE 2

Diagnostic Performance of the Host Signature Assay (for Patients With Suspicion of Acute Infection)

Accuracy MeasureAssay Performance (95% CI)
Sensitivity93.8% (87.8%–99.8%)
Specificity89.8% (85.6%–94.0%)
PPV74.4% (63.6%–83.4%)
NPV97.9% (94.7%–99.4%)
LR+9.2 (6.1–13.9)
LR−0.07 (0.03–0.18)
DOR134.3 (44.4–406.7)
Equivocal11.7%
  • Diagnostic performance was evaluated by comparing the reference standard outcome with the host-signature assay outcome; “positive” refers to a bacterial outcome. As predefined in the statistical analysis plan, the reference standard outcomes were assigned according to expert panel majority (n = 307). DOR, diagnostic odds ratio; LR-, negative likelihood ratio; LR+, positive likelihood ratio; NPV, negative predictive value; PPV, positive predictive value.