Evaluation of a New Automated Platform for the Detection and Quantification of HEV RNA

Hepatitis E virus (HEV) is a major cause of acute hepatitis worldwide. We evaluated the performance of the fully automated HEV RNA assay (HEV ELITe MGB® Kit) using the ELITe InGenius instrument. The limit of detection was established in line with the WHO standard (genotype 3a) and genotype 3f and 3c clinical samples. Finally, the analytical performance of the HEV ELITe MGB® Kit was compared with the Altostar® HEV RNA assay by testing 292 plasma samples and 10 stool samples. The ELITe tool utilized 200 µL of plasma or stool suspension eluted in 100 µL. Linearity was verified from 2 × 10⁶ IU/mL to 2 × 10³ IU/mL. The limit of detection for HEV-3a, HEV-3c, and HEV-3f samples ranged from 485 to 523 IU/mL. The qualitative results obtained with both assays were concordant for 276/292 samples (94.5%) and good correlation was observed between both results for positive samples (ρ = 0.98, p < 0.001). Sixteen samples tested negative with the ELITe assay but were positive using the Altona test, with viral loads ranging from 0.3 to 2.99 log₁₀ IU/mL. All HEV RNA were detected in stool samples with both methods. These results indicated a lack of sensitivity for the ELITe assay. A second protocol using 600 µL of sample eluted in 50 µL of solution was evaluated and presented a limit of detection of 69 IU/mL using the WHO standard. While the ELITe assay demonstrated good linearity and correlation with the AltoStar® assay, it struggled to detect low levels of HEV RNA. However, a new extraction protocol may help to overcome this drawback but needs further validation and changes in the package insert of the manufacturer.