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Discriminating Bacterial and Viral Infection Using a Rapid Host Gene Expression Test.

Publication ,  Journal Article
Tsalik, EL; Henao, R; Montgomery, JL; Nawrocki, JW; Aydin, M; Lydon, EC; Ko, ER; Petzold, E; Nicholson, BP; Cairns, CB; Glickman, SW ...
Published in: Crit Care Med
October 1, 2021

OBJECTIVES: Host gene expression signatures discriminate bacterial and viral infection but have not been translated to a clinical test platform. This study enrolled an independent cohort of patients to describe and validate a first-in-class host response bacterial/viral test. DESIGN: Subjects were recruited from 2006 to 2016. Enrollment blood samples were collected in an RNA preservative and banked for later testing. The reference standard was an expert panel clinical adjudication, which was blinded to gene expression and procalcitonin results. SETTING: Four U.S. emergency departments. PATIENTS: Six-hundred twenty-three subjects with acute respiratory illness or suspected sepsis. INTERVENTIONS: Forty-five-transcript signature measured on the BioFire FilmArray System (BioFire Diagnostics, Salt Lake City, UT) in ~45 minutes. MEASUREMENTS AND MAIN RESULTS: Host response bacterial/viral test performance characteristics were evaluated in 623 participants (mean age 46 yr; 45% male) with bacterial infection, viral infection, coinfection, or noninfectious illness. Performance of the host response bacterial/viral test was compared with procalcitonin. The test provided independent probabilities of bacterial and viral infection in ~45 minutes. In the 213-subject training cohort, the host response bacterial/viral test had an area under the curve for bacterial infection of 0.90 (95% CI, 0.84-0.94) and 0.92 (95% CI, 0.87-0.95) for viral infection. Independent validation in 209 subjects revealed similar performance with an area under the curve of 0.85 (95% CI, 0.78-0.90) for bacterial infection and 0.91 (95% CI, 0.85-0.94) for viral infection. The test had 80.1% (95% CI, 73.7-85.4%) average weighted accuracy for bacterial infection and 86.8% (95% CI, 81.8-90.8%) for viral infection in this validation cohort. This was significantly better than 68.7% (95% CI, 62.4-75.4%) observed for procalcitonin (p < 0.001). An additional cohort of 201 subjects with indeterminate phenotypes (coinfection or microbiology-negative infections) revealed similar performance. CONCLUSIONS: The host response bacterial/viral measured using the BioFire System rapidly and accurately discriminated bacterial and viral infection better than procalcitonin, which can help support more appropriate antibiotic use.

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Published In

Crit Care Med

DOI

EISSN

1530-0293

Publication Date

October 1, 2021

Volume

49

Issue

10

Start / End Page

1651 / 1663

Location

United States

Related Subject Headings

  • Virus Diseases
  • Transcriptome
  • Middle Aged
  • Male
  • Humans
  • Female
  • Emergency Service, Hospital
  • Emergency & Critical Care Medicine
  • Clinical Laboratory Techniques
  • Biomarkers
 

Citation

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Chicago
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Tsalik, E. L., Henao, R., Montgomery, J. L., Nawrocki, J. W., Aydin, M., Lydon, E. C., … Antibacterial Resistance Leadership Group. (2021). Discriminating Bacterial and Viral Infection Using a Rapid Host Gene Expression Test. Crit Care Med, 49(10), 1651–1663. https://doi.org/10.1097/CCM.0000000000005085
Tsalik, Ephraim L., Ricardo Henao, Jesse L. Montgomery, Jeff W. Nawrocki, Mert Aydin, Emily C. Lydon, Emily R. Ko, et al. “Discriminating Bacterial and Viral Infection Using a Rapid Host Gene Expression Test.Crit Care Med 49, no. 10 (October 1, 2021): 1651–63. https://doi.org/10.1097/CCM.0000000000005085.
Tsalik EL, Henao R, Montgomery JL, Nawrocki JW, Aydin M, Lydon EC, et al. Discriminating Bacterial and Viral Infection Using a Rapid Host Gene Expression Test. Crit Care Med. 2021 Oct 1;49(10):1651–63.
Tsalik, Ephraim L., et al. “Discriminating Bacterial and Viral Infection Using a Rapid Host Gene Expression Test.Crit Care Med, vol. 49, no. 10, Oct. 2021, pp. 1651–63. Pubmed, doi:10.1097/CCM.0000000000005085.
Tsalik EL, Henao R, Montgomery JL, Nawrocki JW, Aydin M, Lydon EC, Ko ER, Petzold E, Nicholson BP, Cairns CB, Glickman SW, Quackenbush E, Kingsmore SF, Jaehne AK, Rivers EP, Langley RJ, Fowler VG, McClain MT, Crisp RJ, Ginsburg GS, Burke TW, Hemmert AC, Woods CW, Antibacterial Resistance Leadership Group. Discriminating Bacterial and Viral Infection Using a Rapid Host Gene Expression Test. Crit Care Med. 2021 Oct 1;49(10):1651–1663.

Published In

Crit Care Med

DOI

EISSN

1530-0293

Publication Date

October 1, 2021

Volume

49

Issue

10

Start / End Page

1651 / 1663

Location

United States

Related Subject Headings

  • Virus Diseases
  • Transcriptome
  • Middle Aged
  • Male
  • Humans
  • Female
  • Emergency Service, Hospital
  • Emergency & Critical Care Medicine
  • Clinical Laboratory Techniques
  • Biomarkers