Certain hepatitis C virus (HCV) core antigen (HCVcAg) tests are accurate enough that they could be used instead of nucleic acid testing (NAT), Reuters reports. Publishing their findings in The Annals of Internal Medicine, researchers conducted a systematic review and meta-analysis of 44 studies that evaluated five commercially available HCVcAg tests compared with NAT assays.
Currently, testing for hep C involves an antibody test followed by an NAT to confirm a positive result.
A test’s accuracy is measured in terms of its sensitivity, which assesses accuracy in giving positive results, and its specificity, which measures accuracy in giving negative results.
The respective pooled rates of the tests’ sensitivity and specificity were 93.4 percent and 98.8 percent for the Abbott ARCHITECT assay, 93.2 percent and 99.2 percent for the Ortho HCV Ag ELISA and 59.5 percent and 82.9 percent for the Hunan Jynda HCV Ag ELISA. The pooled analysis did not provide sufficient data on the Eiken Lumispot HCV Ag or the Fujirebio Lumipulse Ortho HCV Ag assays.
Three reports showed that with the use of the ARCHITECT assay, the HCVcAg test result was well matched with the RNA result for an individual with a hep C viral load of at least 3,000.
The researchers concluded, “Although even tests with the highest performance are not as sensitive as NAT, well-performing HCVcAg tests” that are sensitive for those with viral loads of at least 3,000 “could replace NAT for HCV detection, particularly if a lower cost per test allows more patients to be served. Therefore, HCVcAg should be explored for point-of-care testing to increase the number of patients diagnosed and streamline the HCV cascade of care.”
To read a press release about the study, click here.
To read the Reuters article, click here (free registration with Medscape is required).
To read the study abstract, click here.