Sensitivity and Specificity of Anti-Double-Stranded RNA Immunofluorescence for Universal Detection of Viral Infection in Respiratory Specimens

Abstract

Background: Emerging unknown respiratory viruses could be detected early before reaching pandemic level if a universal viral detection procedure was routinely used in clinical practice. Double-stranded RNA (dsRNA) is the only common antigen across most viral families. Anti-dsRNA immunofluorescence (IF) has shown promising results in vitro ; however, its diagnostic value for viral infection in clinical respiratory specimens has not been evaluated. Methods: Consecutive inpatient cases of suspected respiratory viral infections were prospectively enrolled. Respiratory samples were collected and divided for anti-dsRNA IF (index test) and a 19-subtypes respiratory virus microarray (reference standard). Using a fluorescence microscope, positive or negative anti-dsRNA IF results were determined independently by two raters. Findings: By microarray, 108 and 87 samples were positive and negative for viruses, respectively. The anti-dsRNA IF sensitivity was 83.3% (95% CI 76.1% to 90.2%), while specificity was 87.4% (95% CI 80.8% to 93.7%). The overall accuracy was 85.1% (95% CI 80.1% to 89.9%). Interpretation: Anti-dsRNA IF is simple to perform, with acceptable accuracy, and therefore suitable for point-of-care respiratory virus screening. Unlike most molecular techniques, known viral genome sequences are not required. Nevertheless, further refinements to the technique are warranted to improve test sensitivity and specificity. Funding: This study was funded by the Ratchadapiseksompotch Fund, Faculty of Medicine, Chulalongkorn University (Grant Number RA61/061, RA-MF-10/63, and RA-MF-55/64), the Thailand Research Fund, and the Higher Education Commission (MRG6180177). Declaration of Interest: None to declare. Ethical Approval: This study was approved by the Institutional Review Board (IRB number 168/61), Institutional Biosafety Committee (CU-IBC number 008/2018), Chulalongkorn University, and registered in Thai Clinical Trial Registry (TCTR20180129003).