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Rapid, Sample-to-Answer Host Gene Expression Test to Diagnose Viral Infection
Ephraim L Tsalik1,2, Ayeaye Khine3, Abdossamad Talebpour3
1Duke Center for Applied Genomics and Precision Medicine, Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA.
Open Forum Infectious Diseases
|June 21, 2021
Summary
A new host gene expression test accurately distinguishes viral from bacterial infections in under 45 minutes. This rapid diagnostic tool, FAST HR, shows higher accuracy than procalcitonin for identifying infection causes.
Area of Science:
- Molecular diagnostics
- Infectious disease research
- Host response profiling
Background:
- Differentiating bacterial and viral infections is crucial for appropriate antimicrobial stewardship.
- Host gene expression signatures offer a potential diagnostic avenue but lack clinical translation.
- Qvella's FAST HR platform was developed for rapid quantification of these signatures.
Purpose of the Study:
- To evaluate the clinical utility of Qvella's FAST HR platform for distinguishing viral from nonviral etiologies of acute illness.
- To assess the accuracy and speed of the FAST HR assay in a clinical setting.
Main Methods:
- 128 subjects with confirmed viral, bacterial, noninfectious illness, or healthy status were enrolled.
- Whole blood samples were processed using e-lysis for mRNA stabilization and release.
- Quantitative real-time reverse transcription polymerase chain reaction (RT-qPCR) measured 10 host response targets, normalized to a control mRNA.
- Sparse logistic regression with cross-validation was used for etiological classification.
Main Results:
- The FAST HR assay demonstrated high reproducibility in mRNA quantification.
- Overall accuracy for classifying viral versus nonviral etiologies was 90.6%, outperforming procalcitonin (82.0%, P = .06).
- The assay provided rapid results in under 45 minutes.
Conclusions:
- Host gene expression signatures can be translated to clinical platforms for diagnosing suspected infections.
- The FAST HR platform offers a rapid and accurate method for etiological differentiation in acute illness.
