Determining the Lower Limit of Detection Required for HCV Viral Load Assay for Test of Cure

Point-of-care HCV viral load assays are available as an alternative to laboratory-based assays to promote access in hard to reach or marginalized populations. The diagnostic performance and lower limit of detection (LLoD) are important attributes of these new assays for both diagnosis and test of cure.

A study, published in the Journal of Viral Hepatitis, aimed to determine an acceptable LLoD for detectable HCV viraemia as a test for cure, 12 weeks post-treatment (SVR12). It assembled a global data set of patients with detectable viraemia at SVR12 from observational databases from 9 countries (Egypt, the United States, United Kingdom, Georgia, Ukraine, Myanmar, Cambodia, Pakistan, Mozambique) and two pharmaceutical-sponsored clinical trial registries.

It concluded that an assay with a level of detection of 1000 IU/mL or greater may miss a proportion of those with low-level treatment failure.

Full study results can be accessed here.