Rapid and point-of-care tests accurate for HCV

Rapid diagnostic tests and point-of-care tests for hepatitis C virus (HCV) are accurate enough to be used for first-line screening, according to a new study.

Conventional laboratory tests for HCV infection are costly, and the wait for results can be long. Researchers performed a systematic review and meta-analysis to determine whether rapid diagnostic tests and point-of-care tests, which could save time and money, have acceptable accuracy. Studies that evaluated the diagnostic accuracy of rapid and point-of-care tests for detecting HCV in patients 18 years of age and older were included in the analysis. The results appear in the Oct. 16 Annals of Internal Medicine.

Nineteen studies were reviewed, and 18 were included in the meta-analysis. Studies were stratified by specimen type (oral fluid, whole blood, serum or plasma) or test type (rapid or point of care). High sensitivity was found for point-of-care tests of whole blood and serum or plasma (98.9% [95% CI, 94.5% to 99.8%] and 98.9% [95% CI, 96.8% to 99.6%], respectively), while sensitivity for rapid diagnostic tests of serum or plasma and point-of-care tests for oral fluid were 98.4% (95% CI, 88.9% to 99.8%) and 97.1% (95% CI, 94.7% to 98.4%), respectively. Point-of-care tests of whole blood and serum or plasma had the highest specificity (99.5% [95% CI, 97.5% to 99.9%] and 99.7% [95% CI, 99.3% to 99.9%], respectively), while rapid diagnostic tests of serum or plasma and point-of-care tests of oral fluid had specificities of 98.6% (95% CI, 94.9% to 99.6%) and 98.2% (95% CI, 92.2% to 99.6%), respectively.

The authors noted that test accuracy could have been affected by the use of different reference standards and by co-infection and that the tests used could not differentiate between chronic and acute infection, among other limitations. However, they concluded that point-of-care tests of blood and oral fluid and rapid diagnostic tests of serum or plasma are accurate enough to be used for HCV screening.

“In light of their accuracy and the urgent need to increase hepatitis C screening in marginalized and at-risk populations and in endemic HCV settings, these tests could play a substantial role in expanded global screening initiatives, which would eventually impact the control of HCV infection at the population level,” they wrote.