Diagnostic Accuracy of Two Dengue NS1 Tests: New Biosensors-Based Rapid Diagnostic Test Versus Enzyme-linked Immunosorbent Assay

Abstract: Diverse clinical manifestation makes early dengue diagnosis difficult. Detection of dengue nonstructural 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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