Volume: 33S2 - November 2007
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Point-of-Care (POC) HIV testing refers to the practice, undertaken by health care professionals (HCPs), of providing:
*Note that POC setting refers to settings where HIV testing is offered at the point of care but where the test is performed outside of a designated laboratory.
POC rapid HIV testing needs to be placed within a careful analysis of legal, ethical, and human rights issues.
In addition, those HCPs, approved to perform HIV testing as defined within each province or territory, who are contemplating POC HIV testing using rapid HIV test kits, should be aware of the following:
In October 2005, Health Canada licenced a rapid HIV test for use by HCPs in the POC setting. One requirement for the use of these test kits in the POC setting is that HIV counselling, such as that described in the Canadian Medical Association's 1995 publication Counselling Guidelines for HIV Testing (new guidelines to be published in 2008).
This document replaces the previous version published in 2000 and provides updated clinical and technical information, as well as links to additional information that will help Canadian HCPs implement POC HIV testing with the use of rapid HIV test kits. The HCPs are encouraged to seek additional information by consulting resources/websites found in Section 10 of this document.
POC rapid HIV testing should be carefully considered within the framework of legal, ethical, and human rights concerns. The Federal Initiative to Address HIV/AIDS in Canada and Leading Together: Canada Takes Action on HIV/AIDS (2005-2010) frame the response to HIV/AIDS in a rights-based approach. Further analysis of legal, ethical, and human rights considerations will be provided in a policy framework to address HIV testing in Canada to be published by the Public Health Agency of Canada (PHAC) in 2008.
Standard HIV testing is performed in designated laboratories and consists of the following three steps (Figure 1):
Rapid POC HIV testing is performed at a POC setting outside the laboratory. Rapid HIV test kits are designed for single use only to test for HIV antibodies (similar to step 1 in Standard HIV testing). Currently, licenced rapid HIV tests in Canada use either whole blood or serum as the specimen type. HCPs should be aware that rapid HIV test kits may be designed to detect either HIV-1 or HIV-2 antibodies only, or both. Any claims made by a manufacturer are verified by Health Canada through a licencing process. Confirmatory HIV testing at an approved HIV testing laboratory is required for all patients with an HIV reactive result using a rapid HIV test. Parallel testing for non-reactive HIV tests may also be appropriate as part of quality assurance procedures, when required by a specific provincial/territorial policy.
Challenges include, but are not limited to, the following:
POC HIV testing requires that pre- and post-test counselling be modified from the usual HIV counselling that accompanies standard HIV testing (Table 1). This results from the immediate availability of test results. Note that pre- and post-test HIV counselling by trained HCPs remain equally critical components in either the standard HIV or rapid HIV testing scenarios. It is noted, however, that certain clinical situations may make detailed pre-test counselling difficult, e.g. rapid testing for pregnant women in labour. In these situations, informed consent for testing is a minimum requirement.
Pre- and post-test counselling has implications beyond legal and human rights. It is a delicate point in clinical relations with the test subject, and presents ethical issues that the HCP must consider to fully discharge professional duties.
Informed consent is a process of communication that enables a person to make a reasonable and informed decision. Consent is always contextual. Capacity to give fully informed consent implies the ability to understand the nature, benefits and consequences of a proposed health service and potential diagnosis. To be truly informed, consent requires full awareness of all relevant information - and to be true counselling, the process requires substantively more than mere delivery of information, important as this may be. The Canadian Medical Association has taken a position on consent, and has provided directives to medical practitioners (see Box 1). Some provinces have directions on informed consent. Please refer to Table 4 to obtain further information.
Pre-test counselling is critical in preparing patients for the implications of the test, and in cases of reactive test results, ensuring that they return for confirmatory test results.
Post-test counselling has obvious implications whether or not the result is reactive. In the case of a non-reactive test result, the counselling session provides the opportunity for an exchange of information on the individual's perceived risk and co-factors, and on harm reduction and prevention.
With reactive test results, the implications are just as great in terms of reduction in risk of transmission, provision of health care information, and referral to community services.
However, the HCP, in a post-test counselling situation with a patient with reactive test results now also has the responsibility to provide information beyond the usual public health contexts on matters, such as harm reduction, prevention, and partner notification.
Following the Supreme Court of Canada's decision in R vs. Cuerrier requiring individuals who know they are HIV positive to disclose their HIV status to sexual partners before engaging in conduct that poses a significant risk of serious bodily harm, it is recommended that HCPs inform a newly diagnosed HIV+ individual of the possibility of criminal charges arising from failure to disclose and/or exposure of another to HIV, even in cases where actual transmission does not occur.
In contrast to the situation in standard HIV testing, the HCP in the POC setting assumes responsibility for both specimen collection and testing (Table 3). Adequate resources, appropriate training and the implementation of quality assurance practices will be critical in ensuring the proper administration of the test and the correct interpretation of the test result. Further information concerning quality assurance practices is available in the package insert accompanying the test kits.
Rapid HIV test kits must be licenced by Health Canada before they can be offered for sale in Canada. Manufacturers are required to provide data to Health Canada demonstrating that the kits can be used safely and effectively by the intended users. Health Canada requires that these kits only be used in settings where pre- and post-test HIV counselling is available. Any use of the kit for other than the approved and intended use could be viewed as a breach of ethical conduct by the HCP, who may be subject to a complaint to the provincial or territorial licencing body and liable for legal action.
The rapid HIV test kit is designed for single use on one specimen. The package insert for the rapid test kit indicates the appropriate sample type (e.g., finger prick blood, saliva, etc.). A result is obtained rapidly, normally within minutes. Any rapid HIV test kit licenced by Health Canada for POC HIV testing will have similar sensitivity, specificity, and other performance characteristics to HIV diagnostic test kits licenced for laboratory use. Currently, available rapid HIV tests have a reported sensitivity and specificity of ≥ 99.0%. However, due to the possibility of both false negative and false positive results, it is recommended that all reactive tests are accompanied by confirmatory testing. Note that some jurisdictions may require standard/parallel testing to confirm some or all negative tests with standard/parallel testing.
Rapid HIV test kits from various manufacturers will differ in directions, contents, time-sensitive steps, read times, and configurations. HCPs will need to familiarize themselves with the directions, contents, specific processing steps, and configurations of the kit(s) they will be using.
In general, a specimen from the patient is collected as per appropriate sample type (e.g. fingerstick blood, saliva, etc. depending on the test kit). The sample may be mixed with specimen diluent prior to being added to the device, or alternatively, the sample may be added directly to the device. A short incubation may ensue and a detection reagent may be added.
When HIV antibodies are present in the patient's sample in sufficient quantity, a colour reaction will be observed along the test strip.
Rapid HIV test kits are designed to include an internal sample control to ensure the specimen was added and the assay procedure was followed properly. For a test result to be valid, a reaction must be observed with this control.
In addition, a manufacturer of a rapid HIV test kit must have external test controls (both positive and negative) available. These controls serve to ensure that the test has been performed properly and that the user is able to correctly interpret test results.
The rapid HIV test kit provides a reliable final test result that permits the HCP to complete HIV testing and counselling in a single visit. However, as for other HIV antibody tests, a small number of HIV-infected individuals will have a negative HIV rapid test result. Pre- and post-test counselling is critical to assess a person's risk of infection (Table 1).
Despite a negative rapid HIV test result, all patients who have had any HIV risk activity in the previous 3 months should be informed of the benefits of repeat HIV testing (refer to Section 6: Rapid HIV Tests and Seroconversion). In the case of other clinical circumstances, such as hepatitis C infection, symptoms or signs of an acute seroconversion illness, or any other unexplained clinical features in the context of HIV risk activity, the HCP may wish to consult with HIV experts (Table 4) regarding additional testing to detect early HIV infection and recommend repeat HIV testing for patients with an initial negative HIV test. In addition, in acute care settings (e.g., pregnant women in labour) with a non-reactive rapid HIV test, further management will be influenced by a risk assessment of the patient's situation to consider if she/he might be in the window period for HIV detection.
A small number of people who are not HIV infected will produce a positive (reactive) result when tested with an HIV antibody test kit, including the rapid test. Because of this, all reactive test results must be confirmed using a laboratory-based confirmatory test. The importance for confirmatory testing at an approved HIV testing laboratory (see Figure 1) needs to be emphasized to rule out the possibility of a false-positive result in the rapid HIV test and to confirm a true positive result. In pre-test counselling, patients should be informed of, and consent to, a venous sample being sent to an approved HIV testing laboratory should their rapid HIV test result be positive, invalid or indeterminate. In addition, counselling should detail that immediate action will be taken in response to a preliminary positive test result in certain clinical situations (e.g., recipients in blood and body fluid exposures may be started on HIV post-exposure prophylaxis if the source tests reactive to HIV, or pregnant women in labour may be started on intravenous AZT, etc.).
Further Action Required by the HCP with a Preliminary Positive Result - The HCP should write the test result, the kit name, and lot number on the HIV testing requisition. The HIV testing laboratory can process the patient's sample accurately for HIV confirmatory testing when provided with this information. Similar detailed information on the kit and lot number should be written in the patient's medical record. HCPs may also wish to know the expected time of confirmed results so that they can provide appropriate information and schedule a follow-up appointment for their patient.
In some cases, the rapid HIV test may produce an invalid test result. An invalid test result will occur if there was a problem with the sample or with the test device. The test can be repeated with a new sample and a new device. If the test result is again invalid, then a venous blood sample must be drawn and submitted to an approved laboratory for confirmatory testing (as per a preliminary positive result). Some rapid HIV test kits may also describe a situation where a test result is considered indeterminate. An indeterminate test result cannot be interpreted as positive (reactive) or negative. In the case of an indeterminate test result, a venous blood sample must be drawn and submitted to an approved laboratory for confirmatory testing (as per a preliminary positive result).
All HIV tests that rely on the presence of HIV-specific antibodies are less reliable for patients who are in the period of HIV seroconversion, often called the HIV window period. During the window period, the patient's immune response has not yet produced detectable levels of HIV-specific antibodies. HIV testing may not be reliable in patients who have had HIV-risk activity in the previous 3 months, consequently they should be counselled on the need for appropriate repeat HIV testing. Experts at HIV testing laboratories can provide guidance to the HCP, in addition to providing more comprehensive, specific HIV testing procedures for patients who may be in the HIV window period. HCPs may wish to provide specific clinical information on the HIV testing requisition that will alert laboratory experts to undertake a more complex panel of HIV tests for specimens from such patients. Details such as the date of HIV-risk activity or exposure and any clinical symptoms or signs suggestive of HIV seroconversion might be included.
HIV infection is reportable under public health legislation in all provinces and territories. HCPs are required to report identified cases of HIV infection to the public health system; to assist in contact tracing and counselling of the patient; and to maintain accurate HIV epidemiologic information. Approved HIV testing laboratories ensure that cases of HIV infection are reported to the public health system.
In the rare event that a patient with a preliminary positive or invalid result using a rapid HIV test kit refuses to provide a venous blood sample for confirmatory HIV testing, the HCP must encourage and support the patient to undergo such testing.
If the patient still does not complete confirmatory HIV testing, the HCP should solicit advice from public health officials on provincial or territorial public health reporting requirements.
Data on negative test results can provide an indicator of testing volume and, to some extent, of testing patterns and behaviours. In addition, negative test results can be used to develop incidence and prevalence estimates for HIV. Reporting requirements for all types of positive and negative HIV tests differ from one province and territory to another.
In the event of kit failure, the HCP should report the problem to the manufacturer. The manufacturer is required to keep records of reported problems and is subject to mandatory problem reporting requirements under the Medical Devices Regulations. The HCP must also consider reporting the issue separately to the Health Products and Food Branch Inspectorate (HPFBI), Health Canada, at 1-800-267-9675.
PHAC acknowledges the assistance of the Federal/Provincial/Territorial Advisory Committee on HIV/AIDS; National Laboratory for HIV Reference Services, Surveillance and Risk Assessment Division, the Canadian Association for HIV Clinical Laboratory Specialists (CAHCLS) and the HIV/AIDS Policy, Coordination and Programs Division, Centre for Infectious Disease Prevention and Control, Public Health Agency of Canada; expert reviewers of this document; and the Medical Devices Bureau, Therapeutic Products Directorate, HPFB, Health Canada.
The CAHCLS has reviewed this document.
This document is a revised version of the initial document published in 2000 by the following authors:
DL-P Kilby, MD, Ottawa, Ontario; CJ Major, BSc, MLT, Central Public Health Laboratory, Etobicoke, Ontario; MH Steben, MD, Montreal,Quebec; WD Sutherland, MD, Bureau of HIV/AIDS, STD and TB, Laboratory Centre for Disease Control, Health Protection Branch; GA Bally, MD, HIV/AIDS Policy, Coordination and Programs Division, Health Promotion and Programs Branch, Health Canada, Ottawa, Ontario.
HCPs using POC HIV testing will need to adapt their pre- and post-test counselling and their standard HIV testing and counselling procedures. Reference to the benefits of rapid HIV testing including quicker results, early access to health care, etc. are important factors that should be relayed to the client.
Preliminary post-test counselling after a negative result from a rapid HIV test kit
Assess the risks that the patient undergoing testing may face, and provide supportive counselling and information, as appropriate. This will involve providing accurate information on risk behaviour, potential links to community resources, and rationale for behaviour changes needed to reduce risk.
Preliminary post-test counselling after a preliminary positive, indeterminate or invalid result from a rapid HIV test kit
Table 2: Checklist for POC HIV Testing Using Rapid HIV Test Kits
Before Using Kits
Use of the Rapid HIV Test Kit
Expiry Date, Storage, and Disposal
Each POC setting will have unique challenges to address before rapid HIV testing can be offered. However there are several basic elements of quality assurance and quality control practices that can be implemented to ensure highquality HIV testing. These include the following:
There is no question that implementing these procedures will require the development of new documentation (forms) within each POC setting.
A. Sources for laboratory experts on HIV testing
Newfoundland Public Health Laboratory
The Leonard A. Miller Centre
St. John's, Newfoundland and Labrador
Dr. Sam Ratnam
Department of Laboratory Medicine
Queen Elizabeth Hospital Inc.
Charlottetown, Prince Edward Island
Dr. Lou Abbott
Department of Pathology and Laboratory Medicine
QEII Health Science Centre
Halifax, Nova Scotia
Dr. Todd Hatchette
Dr. Everett Chalmers Hospital
Fredericton, New Brunswick
Dr. Jeanne Henry
New Brunswick Provincial Laboratory for Viral Illnesses
Dr. Georges L. Dumont Regional Hospital
Moncton, New Brunswick
Dr. Richard Garceau
Laboratoire de santé publique du Québec
Cadham Provincial Laboratory
Dr. Magdy Dawood
Saskatchewan Disease Control Laboratory
Dr. Paul Levett
Provincial Laboratory for Public Health (Alberta)
Dr. K. Fonseca, (403) 670-1203
Dr. Bonita Lee, (780) 407-3414
Provincial Laboratory, Virology Service
BC Centre for Disease Control
Vancouver, British Columbia
Dr. Mel Krajden
University of British Columbia
Diagnostic Virology and Reference Laboratory
Vancouver, British Columbia
Dr. Chris Sherlock
National Laboratory for HIV Reference Services
Public Health Agency of Canada
Dr. John Kim
HIV Laboratory, Central Public Health Laboratory
For further current information and advice on counselling for HIV testing, please contact your respective provincial/territorial Health ministries.
Extracted from CMA Code of Ethics (Update 2004).
Available online at http://www.cma.ca
Communication, Decision Making and Consent
21. Provide your patients with the information they need to make informed decisions about their medical care, and answer their questions to the best of your ability.
22. Make every reasonable effort to communicate with your patients in such a way that information exchanged is understood.
23. Recommend only those diagnostic and therapeutic services that you consider to be beneficial to your patient or to others. If a service is recommended for the benefit of others, as for example in matters of public health, inform your patient of this fact and proceed only with explicit informed consent or where required by law. (emphasis added)
24. Respect the right of a competent patient to accept or reject any medical care recommended. (emphasis added)
27. Ascertain wherever possible and recognize your patient's wishes about the initiation, continuation or cessation of life-sustaining treatment.
Provinces and territories, such as Ontario and Quebec, have enacted legislation governing consent.
1. Ontario's legislation, the Health Care Consent Act (HCCA) RSO 1990- ch 7, is an example.
Note: “Treatment” includes diagnostic testing for the purposes of interpretation of the HCCA. The HCCA provides, in part:
Elements of consent
1. (1) The following are the elements required for consent to treatment:
(2) A consent to treatment is informed if, before giving it,
(3) The matters referred to in subsection (2) are:
2. In Quebec: Civil code of Quebec, Law on the health services and the social services, codes of ethics of nurses and physicians ...
This information can be found in the "Guide québécois de depistage des ITSS pages 19-21, at "Documentation", section "Professionnels de la santé", /"Guides"
3. Other provincial and territorial jurisdictions may also have taken position on consent. Refer to table 4 to obtain specific provincial information.