Publication: Diagnostic Accuracy of Two Dengue NS1 Tests: New Biosensors-Based Rapid Diagnostic Test Versus Enzyme-linked Immunosorbent Assay
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Date
2020
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Abstract
Diverse clinical manifestation makes early dengue diagnosis difficult. Detection of dengue non structural antigen-1 (NS1) can confirm dengue diagnosis early. This study aimed to compare the diagnostic accuracy of a new biosensors-based rapid diagnostic test (RDT) and an enzyme-linked immunosorbent assay (ELISA) for the detection of dengue NS1 antigen. 91 archived serum samples previously collected from hospitalised patients with suspected dengue were used. 50 cases and 41 controls were ascertained using reverse transcription-polymerase chain reaction, Pan-E Dengue Early ELISA, Immunoglobulin M ELISA, and haemagglutination inhibition. The samples were tested on ViroTrack Dengue Acute and SD Dengue NS1 Ag ELISA by two independent researchers blinded to the reference standard. Statistical analysis was performed using STATA version 12. The sensitivity and specificity of ViroTrack were 92.0% (95%CI 80.8-97.8) and 95.1% (95%CI 83.5-99.4), as compared to 82.0% (95%CI 68.6-91.4) (p=0.03) and 92.7% (95%CI 80.1-98.5) (p=0.32) for the ELISA, respectively. The positive and negative predictive values were 95.8% (95%CI 85.7-99.5) and 90.7% (95%CI 77.9-97.4) for ViroTrack, versus 93.2% (95%CI 81.3-98.6) (p-0.58) and 80.9% (95%CI 66.7-90.9) (p=0.18) for the ELISA, respectively. The diagnostic accuracy of ViroTrack was comparable to ELISA. It may be a more efficient tool for the diagnosis of acute dengue in low resource settings
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Keywords
Dengue, Early diagnosis, Diagnostic accuracy, Biosensors, Rapid diagnostic test