Assessment of Performance and Comparison of Three Commercial HDV RNA Detection Assays: Implications for Diagnosis and Treatment Monitoring

How to cite: Illescas-López, M.; Chaves-Blanco, L.; De Salazar, A.; Hernández-Febles, M.; Carracedo, R.; Lagarejos, E.; Fuentes, A.; Pereira, S.; Cea, M.; De La Iglesia, A.; Freyre-Carrillo, C.; Iborra, A.; Bernal, M.D.V.O.; García-Barrionuevo, A.; Aguilera, A.; Pena, M.J.; García, F. Assessment of Performance and Comparison of Three Commercial HDV RNA Detection Assays: Implications for Diagnosis and Treatment Monitoring. Preprints 2024, 2024020071. https://doi.org/10.20944/preprints202402.0071.v1 Illescas-López, M.; Chaves-Blanco, L.; De Salazar, A.; Hernández-Febles, M.; Carracedo, R.; Lagarejos, E.; Fuentes, A.; Pereira, S.; Cea, M.; De La Iglesia, A.; Freyre-Carrillo, C.; Iborra, A.; Bernal, M.D.V.O.; García-Barrionuevo, A.; Aguilera, A.; Pena, M.J.; García, F. Assessment of Performance and Comparison of Three Commercial HDV RNA Detection Assays: Implications for Diagnosis and Treatment Monitoring. Preprints 2024, 2024020071. https://doi.org/10.20944/preprints202402.0071.v1

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MDPI and ACS Style

Illescas-López, M.; Chaves-Blanco, L.; De Salazar, A.; Hernández-Febles, M.; Carracedo, R.; Lagarejos, E.; Fuentes, A.; Pereira, S.; Cea, M.; De La Iglesia, A.; Freyre-Carrillo, C.; Iborra, A.; Bernal, M.D.V.O.; García-Barrionuevo, A.; Aguilera, A.; Pena, M.J.; García, F. Assessment of Performance and Comparison of Three Commercial HDV RNA Detection Assays: Implications for Diagnosis and Treatment Monitoring. Preprints 2024, 2024020071. https://doi.org/10.20944/preprints202402.0071.v1

APA Style

Illescas-López, M., Chaves-Blanco, L., De Salazar, A., Hernández-Febles, M., Carracedo, R., Lagarejos, E., Fuentes, A., Pereira, S., Cea, M., De La Iglesia, A., Freyre-Carrillo, C., Iborra, A., Bernal, M.D.V.O., García-Barrionuevo, A., Aguilera, A., Pena, M.J., & García, F. (2024). Assessment of Performance and Comparison of Three Commercial HDV RNA Detection Assays: Implications for Diagnosis and Treatment Monitoring. Preprints. https://doi.org/10.20944/preprints202402.0071.v1

Chicago/Turabian Style

Illescas-López, M., María José Pena and Federico García. 2024 "Assessment of Performance and Comparison of Three Commercial HDV RNA Detection Assays: Implications for Diagnosis and Treatment Monitoring" Preprints. https://doi.org/10.20944/preprints202402.0071.v1

Abstract

Precise HDV-RNA detection and quantification are pivotal for accurate diagnosis and monitoring of response to newly approved treatment. We evaluate the performance of three assays: Hepatitis Delta RT-PCR system, EurobioPlex HDV assay, and the RoboGene HDV RNA Quantification kit 2.0, testing 151 HBsAg-positive samples, 90 HDV-RNA negative and 61 HDV-RNA positive. We also evaluated serial dilutions of the WHO international standard for HDV, PEI 7657/12. Finally, all HDV-RNA positive samples were genotyped using a next-generation sequencing strategy. Qualitative results indicated a 100% concordance between tests. Quantitative results correlated well between tests, r2=0.703 (Vircell-vs-Eurobio), r2=0.833 (Vircell-vs-RoboGene), r2=0.835 (Robogene-vs-Eurobio). Bias index was 2.083 (Vircell-vs-Eurobio), -1.283 (Vircell-vs-RoboGene), and -3.36 (Robogene-vs-Eurobio). Using the WHO IS, Vircell overestimated the viral load by 0.98 log IU/mL, Eurobio by 1.46 log IU/mL, and RoboGene underestimated it by 0.98 log IU/mL. Fifty-nine samples were successfully genotyped (Genotype 1, n=52; Genotype 5, n=7; Genotype 6, n=1), with similar results in terms of correlation and bias. The three assays demonstrate promising performance. Their accuracy, reflected in concordance rates and quantitative analysis, makes them suitable for clinical practice. However, in the absence of assay harmonization, quantitative HDV RNA monitoring should be performed in the same laboratory and assay to avoid variability.

Keywords

hepatitis delta virus; molecular diagnosis; viral hepatitis

Subject

Medicine and Pharmacology, Epidemiology and Infectious Diseases

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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