Accurate quantification using the new RoboGene HDV RNA Quantification Kit 3.0: A European multicenter study.

Area of Science:

• Virology
• Molecular Diagnostics
• Hepatology

Background:

• Chronic hepatitis delta necessitates reliable hepatitis delta virus (HDV) RNA detection and quantification systems.
• Variability in results across laboratories hinders effective patient management and clinical trials.

Purpose of the Study:

• To evaluate the comparability of results from seven European laboratories using a new HDV RNA quantification kit.
• To establish correction factors (CFs) for harmonizing HDV RNA concentrations across different test systems.

Main Methods:

• Correction factors (CFs) were determined using the 1st WHO International Standard for HDV RNA.
• Limits of detection (LODs) were assessed via serial dilutions of the WHO IS HDV RNA.
• Accuracy and performance were evaluated using reference materials and patient plasma sample pools.

Main Results:

• Correction factors varied significantly (14 to 10,000) depending on the specific test system employed.
• Limits of detection ranged widely from <2.2 to >575 IU/mL.
• Sensitivity issues were noted, with low concentrations missed by less sensitive systems, and some inter-laboratory discordance in sample analysis.

Conclusions:

• Test-specific CFs are essential for harmonizing HDV RNA quantification.
• Appropriate nucleic acid extraction platforms are critical for achieving adequate detection limits.
• High sensitivity and accurate quantification are vital for monitoring treatment response and advancing clinical trials for novel anti-HDV therapies.