10.0 Point of Care for HCV in Community Settings

No Point of Care (PoC) tests for HCV are currently approved for use in Australia, however, a number of anti-HCV tests which show a similar sensitivity and specificity to commercial laboratory anti-HCV enzyme immunoassays have Food and Drug Administration (FDA) approval and CE marking. Such rapid assays may yet find a niche in HCV testing in Australia; they offer an opportunity for testing of people who may otherwise not seek help from traditional medical settings and can provide a result without the individual returning to the site at a later date. 

These tests are likely to be inappropriate for testing of low prevalence populations.

When a PoC test is approved for use in Australia, this section of the policy will be updated.

Some people in the community may access self-administered PoC test from overseas for their personal use. Due to the lack of TGA approval and the variability in test sensitivity and specificity, if  a person indicates they have received a positive or negative PoC test result, this then should be confirmed by standard HCV testing in a NATA accredited diagnostic laboratory.

Further information on Point of Care testing for HCV can be found here.