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EmergingMOL · MolecularMNGSPathogen-agnostic pack

Metagenomic sequencing (unknown etiology)

Metagenomic / unknown etiology

Last reviewed 2026-08-13

Public health significance

The assay you want when the differential is 'we do not know.' Bioinformatics is part of the quality system.

Specimen types

As validated (CSF, plasma, tissue, stool)

Method

Metagenomic NGS

CLIA / validation

LDT. Validate wet lab and bioinformatics as one method. Version the pipeline.

Interpretation

Organism identified / none identified. Specific organisms get SNOMED when called. Pipeline notes belong in NTE.

Reflex / referral

Orthogonal confirmation of unexpected high-consequence organisms.

Quality control

Internal controls, no-template controls, and a characterized positive. Reproducibility of the informatics matter.

Reportability

Report identified reportable organisms. A negative metagenomic run is not a negative for every pathogen.

HL7 / ELR

Evolving LOINC coverage (e.g. 94187-4 family). Prefer coded organism findings plus narrative.

Sources

CDC/APHL genomic epidemiology; local validation records.