Comparative evaluation of a multiplex polymerase chain reaction panel for high-consequence infectious diseases against conventional diagnostics in travelers with febrile diseases

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OBJECTIVES: Infectious diseases and high-consequence infectious diseases (HCID), are often present in febrile travelers. Multiplex polymerase chain reaction (PCR) may help to confirm or rule out HCIDs and thus prevent a delay in treatment or undue isolation. METHODS: The BioFire® FilmArray® Global Fever Panel-RUO was evaluated vs conventional methods in diagnostics in febrile returning travelers. RESULTS: Eighty-two patients and three simulated patients with HCIDs were analyzed. A total of 10 of the 19 possible pathogens were detected by multiplex PCR. In 30 samples, at least one pathogen was detected by the multiplex PCR, as compared to 35 with conventional diagnostics. The positive percentage agreement was 85.71% (69.74-95.19) overall: Crimean-Congo hemorrhagic fever virus 1/1, dengue virus 4/4, Ebola virus 1/1, Leptospira 1/2 (50%, 1.26-98.74), Marburg virus 1/1, Plasmodium spp. 22/23 (95.65%, 78.05-99.89), Plasmodium falciparum 19/20 (95%, 75.13-99.89), Plasmodium vivax/ovale 2/2, Salmonella enterica serovar typhi 0/2, and Salmonella enterica serovar Paratyphi 0/1. The overall negative percentage agreement was 96.0% (86.29-99.51). CONCLUSION: The multiplex PCR detected pathogens from blood with varying levels of specificity and sensitivity in less than 1 hour. For HCID, it could shorten the time to diagnosis. However, Salmonella enterica spp. or Leptospira spp. were detected infrequently.