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2.0 Types of HIV Testing

Posted in: HIV

This policy covers laboratory based testing and non-laboratory based testing. The TGA has produced guidance to assist and inform its evaluation of HIV tests.

These set out differential performance requirements for laboratory tests, HIV point of care tests and HIV self-tests. They recognise that a lower performance threshold may be acceptable in a test which is part of a screening protocol, requiring confirmatory testing and that confirmatory testing must be able to demonstrate the highest quality and performance. They also specify the need for training. It is essential that those using any test are familiar with its limitations and can convey these to the person being tested or, in the case of a self-test, that the package insert addresses these limitations.
This TGA performance requirements document is prospective and relates to any tests which may be submitted to the TGA for evaluation.

2.1 Laboratory based testing

In addition to the performance standards issued by the TGA, laboratories are additionally subject to requirements established by the NPAAC. Laboratory staff are also subject to professional standards established by the RCPA and international standards under which laboratories receive NATA RCPA Accreditation.

2.2 Point of care testing

Point-of-care tests may have a longer window period than laboratory based tests. [In this policy, reference to ‘point of care tests/testing’ refers to rapid HIV tests being used at point of care.]

In addition to the performance standards issued by the TGA[v], point of care HIV testing services are additionally subject to requirements established by the jurisdictions and medical practitioners performing point of care tests are subject to their own professional standards. Additionally jurisdictions may require those performing HIV point of care tests to contribute to surveillance data collection. Examples of these include:

Sites that perform point of care testing should be enrolled and actively participate in a relevant external quality assurance program and it is recommended that the site contribute to jurisdictional or national data collection.

The application of these requirements is the responsibility of the director of any service which provides HIV testing. The TGA requires that a health professional or appropriately trained user is responsible for performing or supervising all aspects of the testing process from sample collection to test interpretation[viii]. All staff performing HIV point-of-care testing should be able to be able to demonstrate competency in the performance of the tasks for which they are responsible. Training should cover test operation, sample collection and interpretation as well as issues of consent, conveying the result and any confirmatory testing processes. Examples are provided in the following documents:

•             National Curriculum for HIV Point of Care Testing (ASHM) (appendix E)

•             Competency Standards for HIV Point of Care Test Operators (ASHM) (appendix F)

Staff will also need to receive specific training on the operation of any newly introduced point of care test or sample collection process being used in a facility.

Services providing point of care testing should have a clear linkage to clinical and pathology services for the conduct of confirmatory testing. This includes when point-of-care testing is performed in community-based testing services and in an outreach setting, such as a mobile clinic or pop-up site.

2.3 HIV self-testing

The TGA performance requirements establish baseline criteria against which applications for HIV self-tests will be measured. In addition to performance requirements, the document places on the sponsor requirements to mitigate the risks associated with self-testing[ix].While no HIV self-test is currently licensed for that purpose on the Australian Register of Therapeutic Drugs, self-tests are the subject of research studies. Australians can also purchase self-tests while travelling overseas or on-line from overseas suppliers. The TGA performance requirements provide a guide to those performing research and or considering the role of self-test in Australia.

Unlike point-of-care testing, self-testing is performed in the absence of a health care provider or trained operator. It is, therefore, essential that instructions for use (package insert) are sufficiently illustrative and comprehensible so that a user can perform the test correctly and interpret the result. In addition the package insert must explain sensitivity and specificity limitations including the predictive value when used in high and low prevalence populations, the window period, the need for confirmatory testing and referral points.

2.4 Self-sampling for HIV testing

Self-sampling for HIV testing provides opportunities for improving access to testing and increasing frequency of testing among people at risk of HIV infection through minimising the barriers associated with conventional testing e.g. the need to attend a health service to access a test, time taken for test results to be available, poor access to health care providers, stigma and the risk of discrimination. Self-sampling can also support autonomy, and provide added confidentiality, privacy and convenience for people who may not otherwise engage in HIV testing. Dried blood spot sampling is one form of self-sampling that has been successfully applied for decades in early infant diagnosis of HIV and in monitoring prevalence of HIV among injecting drug users. A successful pilot program targeting high risk groups for HIV was recently implemented in the UK.[x]

There is currently no TGA approved dried blood spot test for screening in Australia.

 

Unlike point-of-care testing, in self-sampling such as dry blood spot testing, the analysis is performed in the laboratory and a confirmed result can be obtained.

2.5 Novel testing technologies and/or sample collection processes

The TGA allows for the importation and/or local sourcing of devices for research purposes. The introduction of novel and innovative approaches to HIV testing is recognised in the 7th National HIV Strategy 2014-2017 as a means of enhancing access to testing for priority populations and thereby increasing the identification of undiagnosed HIV in the Australian community. Nevertheless, prior to its availability in the Australian market , any new testing technology and/or sample collection methods should be evaluated and registered by the TGA and be subject to the documented requirements appropriate to the device.



[i] Therapeutic Drugs Administration (2015) Clinical Performance Requirements for and Risk Mitigation Strategies for HIV Testing https://www.tga.gov.au/clinical-performance-requirements-and-risk-mitigation-strategies-hiv-tests (cited 05 May 2015)

[ii] NPAAC Requirements for Laboratory Testing of Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) Edition 3 http://www.health.gov.au/internet/main/publishing.nsf/Content/health-npaac-docs-hivhepc.htm (cited 05 May 2015)

[iv] ISO (2012) ISO 15189:2012 Medical laboratories - Requirements for quality and competence http://www.iso.org/iso/catalogue_detail?csnumber=56115 (cited 05 May 2015)

[v] Therapeutic Drugs Administration (2015) Clinical Performance Requirements for and Risk Mitigation Strategies for HIV Testing https://www.tga.gov.au/clinical-performance-requirements-and-risk-mitigation-strategies-hiv-tests (cited 05 May 2015)

[viii] Therapeutic Drugs Administration (2015) Clinical Performance Requirements for and Risk Mitigation Strategies for HIV Testing https://www.tga.gov.au/clinical-performance-requirements-and-risk-mitigation-strategies-hiv-tests (cited 05 May 2015)

[ix] Therapeutic Drugs Administration (2015) Clinical Performance Requirements for and Risk Mitigation Strategies for HIV Testing https://www.tga.gov.au/clinical-performance-requirements-and-risk-mitigation-strategies-hiv-tests (cited 05 May 2015)

[x] Terrence Higgins Trust, Dean Street and Public Health England (PHE) in the United Kingdom.

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Development of this site and the 2014 and 2017 revisions of the testing policies was supported by: Australian Government Department of Health and Ageing