POINT-OF-CARE AND SELF-TESTS FOR HCV


Point-of-care testing for HCV infection has the potential to simplify testing algorithms, increase diagnoses, and facilitate linkage to treatment. In overseas studies, point-of-care testing has been shown to increase uptake of HCV testing and linkage to HCV care.63,64,65,66 Experts on HIV and tuberculosis diagnostic testing have defined a point-of-care test as ‘’a diagnostic test that is performed near the patient or treatment facility, has a fast turnaround time, and may lead to a change in patient management."67

In May 2020, a point-of-care test for detection and quantification of HCV RNA was approved by the TGA with some conditions. The assay needs to be performed by a laboratory accredited by NATA for HCV testing or by trained health professionals (e.g. in a community health setting) that have an established relationship with a NATA accredited laboratory. The assay shows a similar sensitivity and specificity to traditional commercial HCV RNA assays. Sample type is capillary finger-stick EDTA whole blood. The ability to use finger-stick blood offers a great advantage as it avoids the need for phlebotomy, a major advantage where venous access is difficult or where phlebotomy services are unavailable.68,69  HCV RNA detection and quantification assays are usually performed in specialist centralised laboratories where samples can be batch tested. This procedure can result in longer turnaround times, especially for externally referred samples, resulting in delays in clinical management. The ability to obtain an on-site result in a single visit using the approved point-of-care HCV RNA test is a significant development for increasing the number of people diagnosed with HCV infection and linking directly to care.

A number of point-of-care HCV antibody (anti-HCV) tests which show a similar sensitivity and specificity to commercial laboratory HCV antibody enzyme immunoassays have Food and Drug Administration (FDA) approval and CE marking (subject to one or more of the European product safety Directives).70 None are currently approved for use in Australia.

Some people in the community may access self-administered point-of-care test from overseas for their personal use (self-tests). The safety and performance of these devices may not been independently assessed and verified.

From 1 October 2020, changes to the supply of self-tests under the Therapeutic Goods (Medical
Devices—Excluded Purposes) Specification 2020 came into effect.71 Sponsors and manufacturers can apply for inclusion of allowable self-tests in the ARTG. Individual products will be evaluated by the TGA to ensure the tests are safe and perform as intended by the manufacturer.