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Rapid HIV Testing in Canada

Background On Rapid Tests Approved for Use in Canada
On October 25, 2005, the Medical Devices Bureau of Health Canada approved the INSTI HIV Rapid test (manufactured by bioLytical Laboratories of Richmond, British Columbia) for use in Point of Care settings (i.e., doctor’s offices, clinics and hospitals). This test is licensed for use in Canada to detect HIV-1.

According to bioLytical, INSTI has shown accuracy of 99.6% in clinical trials for both sensitivity and specificity. The sensitivity of the test is the ability of a test to detect truly infected people and the specificity of a test is the ability to identify all non-infected people.

The test takes 60 seconds and is equivalent in performance to laboratory HIV screening tests. But it is just that, a screening test. Tests will either come back negative or initially reactive. If the test comes back “initially reactive”, the term used to indicate a preliminary positive result, it will need to be sent to a laboratory for confirmation. This brings up a number of questions around counselling, including how to effectively communicate what it means to be initially reactive and determining the impact being initially reactive has on someone waiting for test confirmation. The short time frame of the test also changes the nature of counselling, and this is something that still needs evaluation.

There is one other rapid test licensed for use in Canada. MedMira, a Halifax-based company, received Health Canada approval for laboratory use of its Reveal rapid tests in 2004. This test is not licensed for use outside of the laboratory. Neither Reveal, nor INSTI, is licensed for home use.

Health Canada is in the process of revising its Rapid Testing Guidelines.

For more information on the INSTI Test you, please visit the bioLytical website at www.biolytical.com.

Potential Benefits
Because health care providers using rapid tests can supply results to patients at the time of testing, proponents of using on-site, rapid HIV testing argue that the possible benefits include:

Faster results: For those who test negative the results are available right away.

More people receive their results: The number of people who learn their HIV status may increase. The majority of people tests HIV-negative, and can learn this result in a single visit. Those who test initially reactive on this preliminary test are more likely to return for their confirmatory test results.

Wider access to HIV testing: The simpler testing technology makes it easier to deliver HIV testing (with preliminary results) to “hard-to-reach,” high-risk populations, including settings with little access to clinical care.

Prophylaxis decisions: In some circumstances, obtaining preliminary results quickly may assist in making immediate decisions about initiating anti-retroviral therapy in an effort to prevent HIV transmission.

Cost-effectiveness: It may be possible to deliver HIV testing more cost-effectively, as most people (those who test negative) need only a single visit.

Potential Harms
Risk of undermining consent to testing: Some of the potential benefits of rapid HIV testing (e.g., ease of testing, quick results) also mean a heightened risk of abuse, with people being tested without their voluntary, specific, informed consent. To be voluntary, consent must be freely given, without coercion. The person must also be free to change their mind about testing. Consent must also be specifically given to be tested for HIV, rather than the health care professional simply including an HIV-antibody test as part of a series of tests. Finally, for consent to be “informed,” the person requires time to consider their decision to test, and must understand the purposes, risks, harms and benefits of being tested (as well as those of not being tested). The professional administering the test must ensure that these conditions are met before testing. What steps are needed to prevent illegal or inappropriate uses of such kits in the health care setting? What about the illegal sale of such kits which are used outside the health care setting to test people without consent?

Pre-test counselling: Does compressing the time for counselling and testing into such a short period result in poorer quality pre-test counselling? There is already evidence that, in many cases, pre and post-test counselling is inadequate, and this undermines a person’s ability to give truly informed consent. Concerns that rapid testing may negatively affect counselling need to be addressed.

Post-test counseling: Screening tests (including rapid test kits) may yield “false positive” preliminary test results when the person tested is not actually infected. The point of rapid test kits is to make this preliminary result available quickly on the same day. What is the effect of providing people with unconfirmed HIV-positive test results? What guidelines are needed to counsel people receiving initially reactive results from a screening test? How can we ensure people understand the nature of the preliminary result?

Cost-effectiveness: The cost-effectiveness of rapid test kits is not yet clear. While some costs may be saved by providing test results in a single visit (with no return visit required for those testing HIV-negative), the test kits themselves are more expensive per test than the standard ELISA test performed in batches. Additional costs include: training personnel to use the new test kits and interpret results, laboratory technician time, laboratory facilities where they are not already in place, and the counsellor time needed to provide two counselling sessions per patient in one day. Whether the cost of rapid testing kits at point of care settings will be covered by health insurance is still unknown.

Quality assurances: Currently, HIV testing occurs in provincial laboratories that are funded and regulated by each province. There is no third-party independent quality assurance for this test. Presently, the only group making sure it's accurate, batch after batch, is the company that makes it. Licensing for use of HIV tests happens federally, but health care is a provincial issue and, therefore, how the test will be implemented and regulated is largely a provincial concern.

Adapted from “A backgrounder prepared by the Canadian AIDS Society and the Canadian HIV/AIDS Legal Network”, November 1999

Rapid HIV Testing in Canada. © Canadian AIDS Society. Published 09/24/2007. Updated 02/18/2011. Web. Retrieved 07/24/2016 from http://www.cdnaids.ca/rapidhivtestingincanada