Xpert Hemorrhagic Fever

The Xpert Hemorrhagic Fever test is an automated multiplex real-time RT-PCR assay performed on the GeneXpert Edge X system for qualitative detection and identification of RNA from Ebola virus (Zaire, Sudan, Taï Forest, Bundibugyo), Crimean-Congo hemorrhagic fever virus, Marburg virus, and Lassa virus in EDTA-treated whole blood specimens collected by capillary or venous draw. Results are intended as an aid in diagnosis and must be used with other clinical, epidemiologic, and laboratory data; the test is restricted to DoD laboratories with appropriate biosafety and trained personnel.

The device uses multiplex real-time reverse transcription PCR (RT-qPCR) with automated nucleic acid extraction, amplification, and detection on the GeneXpert Edge X instrument with embedded software interpretation. It includes three internal controls (Sample Processing Control, Sample Adequacy Control, Probe Check Control) and provides qualitative results with automated interpretation. The predicate uses multiplexed nested nucleic acid amplification with melt curve analysis; both are single-use, automated systems producing qualitative results in approximately one hour.

The document references Clinical and Laboratory Standards Institute (CLSI) document EP17-A2 for limit of detection studies. ISO 13485 clauses 7.3, 8.3, and 8.5 are cited regarding design controls, nonconforming product, and corrective/preventative action.

The Xpert Hemorrhagic Fever test is substantially equivalent to the BioFire Global Fever Special Pathogens Panel (K213362) because both are multiplex nucleic acid tests detecting biothreat agents from whole blood using automated extraction and real-time PCR-based detection with similar intended uses as aids to diagnosis in laboratories with appropriate biosafety infrastructure. Although the subject device uses RT-qPCR while the predicate uses nested amplification with melt analysis, both achieve the same intended purpose of presumptive identification of viral hemorrhagic fever pathogens with comparable performance characteristics demonstrated by analytical sensitivity, specificity, and clinical performance studies showing 96–100% positive percent agreement and 100% negative percent agreement across multiple strains and concentrations.