Memorias do Instituto Oswaldo Cruz · 2026
Novel epitope-based diagnostic probes selected by phage display for the serological detection of HDV.
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Costa Mariana Araújo, de Souza Rayany Cristina, Roca Tárcio Peixoto, Araújo Adrhyan, de Souza Luiz Fellype Alves, Souza Rutilene Barbosa, Sabatini Rafaela, Andrade Bruno Silva, Soares Iara Pereira, Caixeta Douglas Carvalho, Guevara-Vega Marco, Lima Ildercílio Mota de Souza, Passos-Silva Ana Maísa, Martins Mario Machado, Rayashi Abel Dib, da Matta Daniel Archimedes, Vieira Deusilene, Goulart Luiz Ricardo, Sabino-Silva Robinson, Santos Fabiana de Almeida Araújo
Аннотация
BACKGROUND: Hepatitis delta virus (HDV) is associated with the worst prognosis among viral hepatitis infections; however, it remains largely underdiagnosed, particularly in endemic developing regions, underscoring the need for new, accessible serological methods for large-scale screening.
OBJECTIVES: To develop HDV-mimetic molecules using phage display for application in immunodiagnostic platforms.
METHODS: HDV-mimetic peptides were selected via phage display biopanning, sequenced and screened by phage-enzyme-linked immunosorbent assay (ELISA). Based on the sequences of these peptides, a recombinant protein (rHDV) was constructed and employed in an ELISA. The test was validated using 87 anti-HDV-positive samples and 93 hepatitis B virus (HBV) control samples collected from a public diagnostic laboratory in the Amazon region. Statistical analyses were performed to evaluate the diagnostic performance of the synthetic peptides and the recombinant protein.
FINDINGS: Overall, rHDV exhibits a sensitivity of 74.71%, specificity of 97.85%, and area under the curve (AUC) of 0.8906. In HDV ribonucleic acid (HDV RNA)-positive patients, diagnostic performance improved, with a sensitivity of 88.0%, specificity of 98.92%, and AUC of 0.96.
MAIN CONCLUSIONS: These findings highlight that the rHDV protein used in ELISA effectively discriminated HDV-infected individuals from patients monoinfected with hepatitis B. This demonstrates the potential of rHDV as an effective, rapid, and low-cost tool for HDV detection for broader HDV screening.
OBJECTIVES: To develop HDV-mimetic molecules using phage display for application in immunodiagnostic platforms.
METHODS: HDV-mimetic peptides were selected via phage display biopanning, sequenced and screened by phage-enzyme-linked immunosorbent assay (ELISA). Based on the sequences of these peptides, a recombinant protein (rHDV) was constructed and employed in an ELISA. The test was validated using 87 anti-HDV-positive samples and 93 hepatitis B virus (HBV) control samples collected from a public diagnostic laboratory in the Amazon region. Statistical analyses were performed to evaluate the diagnostic performance of the synthetic peptides and the recombinant protein.
FINDINGS: Overall, rHDV exhibits a sensitivity of 74.71%, specificity of 97.85%, and area under the curve (AUC) of 0.8906. In HDV ribonucleic acid (HDV RNA)-positive patients, diagnostic performance improved, with a sensitivity of 88.0%, specificity of 98.92%, and AUC of 0.96.
MAIN CONCLUSIONS: These findings highlight that the rHDV protein used in ELISA effectively discriminated HDV-infected individuals from patients monoinfected with hepatitis B. This demonstrates the potential of rHDV as an effective, rapid, and low-cost tool for HDV detection for broader HDV screening.