Optimal Limit of Detection for a Point-of-Care HCV Viremia Test

blood work, point of care testing
blood work, point of care testing
Dataset of 66,640 individuals from 12 countries representative of 6 global regions confirmed that a test with a limit of detection of 1318 IU/mL would identify 97% of viremic HCV infections.

Increasing the level of detection of circulating hepatitis C virus (HCV) in diagnostic testing would maintain good test accuracy and would likely allow for the development of more affordable portable tests for use in low- and middle-income countries, according to a study published in the Journal of Hepatology.1

Viral hepatitis is the cause of 1.34 million deaths worldwide, and more than 50 million of the estimated 70 million cases of chronic HCV occur in low and middle income countries.2,3 Current diagnostic tests can detect as little as 12 IU/mL of virus, however affordable point-of-care tests for HCV are needed to improve access to treatment in these areas.1 Researchers sought to determine the target level of detection necessary to diagnose most cases of HCV that are eligible for treatment and identify characteristics associated with low-level viremia (defined as the lowest 3% of the distribution of HCV RNA) to understand those at risk for misdiagnosis.

They established a multicountry cross-sectional dataset of HCV RNA linked to demographic and clinical data that included 66,640 individuals with HCV viremia from Georgia (44.4%), Canada (40.9%), India (8.1%), Cambodia (2.6%), Egypt (1.6%), Pakistan (1.3%), Cameroon (0.4%), Indonesia (0.2%), Thailand (0.2%), Vietnam (0.1%), Malaysia (0.05%), and Mozambique (0.02%) and found that a 97% level of detection was 1318 IU/mL. In addition, factors associated with low-level viremia were younger age (18-30 years), female sex, and advanced fibrosis stage F4.   

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The study authors concluded that, “A product specification that allows for a level of detection of 1318 IU/mL could facilitate development of an affordable non-molecular [point-of-care] test that could dramatically increase rates of HCV testing and treatment initiation in [low- and middle-income countries], thus substantially impacting health outcomes for chronic HCV infection on a population-level.”1


  1. Freiman JM, Wang J, Easterbrook PJ, et al. Deriving the optimal limit of detection for an HCV point-of-care test for viraemic infection: analysis of a global dataset [published online February 20, 2019]. J Hepatol. doi: 10.1016/j.jhep.2019.02.011
  2. World Health Organization. Global hepatitis report, 2017.  www.who.int/hepatitis/publications/global-hepatitis-report2017/en/. April 2017. Accessed March 8, 2019.
  3. Gower E, Estes C, Blach S, Razavi-Shearer K, Razavi H. Global epidemiology and genotype distribution of the hepatitis C virus infection. J Hepatol. 2014;61(1 Suppl):S45-S57.