Point of care (POCT) testing for human immunodeficiency virus (HIV) infection in Australia: in context

Abstract

The laboratory diagnosis of HIV infection is most often made by the detection of antibodies to the virus. Conventional serologi-cal tests for detection HIV antibodies are usually referred to as ‘screening or standard’ tests (the initial test) or ‘confirmatory, supplemental or reference tests’. Screening tests identify samples that contain antibodies to HIV but are usually not used to provide a presumptive diagnosis for a patient whose sample is found to be initially reactive. Only after confirmatory or reference tests have been performed can an individual conclusively be identified as being seropositive and having established HIV infection. Screening and confirmatory tests are performed in a testing strategy which has been scientifically validated for a particular population demographic to provide the most sensitive and specific result for the individual tested. For many years, point of care (PoCT, rapid or short incubation) tests for HIV have been successfully used in many developed and developing countries. In 2012, the US Food and Drug Administration (FDA) announced the approval of a home test or over-the-counter HIV PoCT that would enable individuals to perform self-testing. In many countries the use of rapid tests has overcome resource constraints where laboratory infrastructure and sample transportation logistics are limited, in remote settings and in populations where the return rate for receiving a confirmed result is poor. Recent research suggests that much HIV transmission occurs from people who have themselves only recently have become infected. Many approaches have been tried to increase the demand for testing and improve rates of testing amongst people at risk of acquiring HIV. There is a strong case of for the introduction of PoCT for HIV in Australia including the desire to improve the rates of testing for populations at risk of infection. Reducing barriers around testing through improving access and consumer experiences suggests that more convenient testing could increase the rates of testing and stimulate the demand for HIV testing in target groups. In Australia, all in vitro diagnostic devices (IVD) are regulated according to a public health risk stratification. Currently all HIV and HCV screening tests are classified in the highest category (Class 4) and undergo a high degree of scrutiny before they are approved for registration on the Australian Register of Therapeutic Goods (ARTG) and approved for sale. This ensures that tests that are available in the Australian market are of a high standard. At the time this abstract was prepared there were two PoCT tests approved on the ARTG; however, one test was approved for use as a screening test and could only be used in laboratory settings. In 2011, the National HIV Testing Policy underwent significant review and established a framework for the introduction of PoCT in Australia proposing standards around training, settings and quality assurance. This presentation will outline the current situation of point of care tests for HIV in Australia and highlight some issues around their introduction and regulation in the broad non-laboratory based context. Data will be presented on the performance of participants in the Royal College of Pathologists of Australasia (RCPA) external quality assurance program (QAP) for HIV PoCT, highlighting issues with quality in regional laboratories where PoCT are widely used.