Infectious Disease

BioFire Global Fever Panel successfully detects common acute fever-causing pathogens

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Disclosures:
Manabe reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.

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A 1-hour sample-to-answer, molecular device successfully detected common causative pathogens of acute febrile illness with high positive and negative percent agreement directly in whole blood, according to a recent study.

“Fever is a common presenting symptom in low- and middle-income countries, and diagnostics are limited,” Yukari C Manabe, MD associate director of global health research and innovation and professor of medicine at Johns Hopkins Medicine, told Healio. “Having a simple assay that could establish a diagnosis for commonly encountered pathogens allows for targeted treatment.”

Yukari C. Manabe

Manabe and colleagues assessed the performance of the BioFire Global Fever Panel (GF Panel), a multiplex nucleic acid amplification test performed on whole blood specimens run on the BioFire FilmArray System, in nine countries. They assessed six of the analytes on the panel — chikungunya virus, dengue virus, Leptospira, Plasmodium species, Plasmodium falciparum, and Plasmodium vivax or Plasmodium ovale — in a prospective, multicenter, cross-sectional diagnostic accuracy study.

According to the researchers, adults and children aged older than 6 months presenting with fever in the previous 2 days were enrolled consecutively in sub-Saharan Africa (Ghana, Kenya, Tanzania and Uganda), Southeast Asia (Cambodia and Thailand), Central and South America (Honduras and Peru), and the United States (Washington, DC, and St. Louis). They then calculated the positive percent agreement and the negative percent agreement of the GF Panel compared with comparator assays.

Between March 26, 2018, and Sept. 30, 2019, 1,965 participants were enrolled at 10 sites, 1,875 of whom had analyzable results, with at least one analyte being detected in 657 (35%) of the specimens. Overall, the GF Panel had a positive percent agreement of 100% for chikungunya virus (95% CI, 86.3-100), 94% for dengue virus (95% CI, 90.6-96.5), 93.8% for Leptospira (95% CI, 69.8-99.8), 98.3% for Plasmodium species (95% CI, 96.3-99.4), 92.7% for P. falciparum (95% CI, 88.8-95.6), and 92.7% for P. vivax or P. ovale (95% CI, 86.7-96.6). Additionally, the GF Panel had a negative percent agreement equal to or greater than 99.2% (95% CI, 98.6-99.6) for all analytes.

“For the six analytes, there was excellent performance,” Manabe said. “This is the first sample-to-answer 1-hour molecular PCR test on whole blood that assays for commonly encountered pathogens causing fever.”

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