Nov. 4, 2026—The Food and Drug Administration has cleared Beckman Coulter Diagnostics’ Access MeMed BV assay. The automated host-response test measures three immune-response proteins, TRAIL, IP-10, and CRP, in serum or plasma from adult and pediatric patients with suspected acute infection and symptoms lasting fewer than seven days. The assay generates a score indicating the likelihood of bacterial infection and is intended for use in conjunction with clinical assessment and other laboratory findings for patients evaluated in emergency departments or urgent care settings, or from samples collected at hospital admission.
The assay is available on the Access 2 and DxI 9000 immunoassay analyzers; results on the DxI 9000 are available in as few as 15 minutes.