Diagnostic Performance and Kinetics of Hepatitis E Viral RNA and IgM Antibody Test Positivity in a Genotype 1 Outbreak in South Sudan - Summary - MDSpire
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Diagnostic Performance and Kinetics of Hepatitis E Viral RNA and IgM Antibody Test Positivity in a Genotype 1 Outbreak in South Sudan
To evaluate the performance of PCR, IgM ELISA, and Assure HEV IgM RDT during a hepatitis E genotype 1 outbreak, focusing on sensitivity, specificity, and the duration of viremia and antibody responses.
Key Findings:
Among 893 suspected cases, PCR sensitivity declined with time from jaundice onset.
Within 30 days of jaundice onset, PCR sensitivity was 73% (95% CrI: 27, 90), RDT was 86% (95% CrI: 74, 93), and ELISA was 95% (95% CrI: 91, 98).
Specificity was high across tests: PCR at 98% (95% CrI: 98, 99), RDT at 95% (95% CrI: 93, 96), and ELISA at 95% (95% CrI: 93, 96).
Median time from jaundice onset to negative test was 19 days (95% CI: 17, 21) for PCR and 113 days (95% CI: 87, 163) for ELISA.
The Assure IgM RDT showed higher sensitivity than PCR and similar specificity to IgM ELISA.
Interpretation:
The Assure IgM RDT is effective for identifying hepatitis E in outbreak settings, with care-seeking delays significantly impacting the timing and interpretation of diagnostic test results.
Limitations:
Field performance of tests may vary due to sample collection and transport conditions, which can lead to variability in test results.
Limited existing evidence on the natural history of HEV and antibody kinetics complicates the understanding of diagnostic performance.
Conclusion:
The study highlights the importance of rapid diagnostic tests in surveillance and outbreak response for hepatitis E, especially in resource-limited settings, and underscores the need for timely interventions.
by Aybüke Koyuncu, Robin C Nesbitt, Catia Alvarez, Kinya Vincent Asilaza, Joseph Wamala, Melat Haile, Etienne Gignoux, Manuel Albela, Emily S Gurley, Frederick Beden Loro, Duol Biem, Monica Rull, John Rumunu, Iza Ciglenecki, Isabella Eckerle, Andrew S Azman
