This document provides recommendations on the use of rapid HIV tests. Rapid HIV testing can provide a result within 10 to 30 minutes compared to 1-2 weeks for the enzyme immunoassay (EIA). The accuracy of rapid tests is comparable to the standard EIA tests. Rapid HIV testing must be conducted according to the same ethical standards as for any other HIV test including pre and post-test counselling, informed consent, privacy, and confidentiality.
Rapid tests to detect antibodies to HIV can enable health providers to supply definitive negative and positive results to patients at the time of testing. Most people receiving rapid HIV test results can receive counselling and learn their HIV status in a single visit. Therefore rapid testing can increase the number of people undergoing HIV testing who know their results. Rapid testing may also assist in facilitating the diagnosis of HIV infection, improving HIV testing capabilities in facilities without access to laboratories, and facilitating post exposure prophylaxis in health workers following occupational exposure to blood and body fluids. Rapid tests have important implications for HIV counselling procedures.
The standard test to screen for antibodies to HIV is the enzyme immunoassay (EIA). This test requires the collection of serum and specialised equipment. EIA tests often require transporting specimens from health facilities to laboratories that may cause delays of 1 to 2 weeks to receive results. Reactive or positive EIA results are repeated or confirmed by another HIV antibody test.
Rapid HIV testing can be performed more quickly than the EIA and can provide a result within 10 to 30 minutes. Some of these rapid tests can be done without the need of a formal laboratory, often ‘at the bed side’. Many rapid tests are relatively easy to use and can be conducted and read by non-laboratory personnel such as clinical doctors and nurses. Some are being marketed to the lay public for ‘self testing’ purposes. All rapid tests, however, are subject to error if the testing protocol is not strictly followed.
The sensitivities (accuracy in detecting HIV positivity) and the specificity (accuracy in detecting HIV negativity) of these rapid tests are similar to the standard EIA tests. The negative predictive value (accuracy of a negative test result) of rapid tests is accurate enough to exclude HIV infection if the test is negative. It is recommended that a confirmatory test be performed with another rapid test or with an EIA.
Rapid HIV testing must be conducted according to the same ethical standards as for any other HIV test including pre and post-test counselling, informed consent, privacy, confidentiality and the right of refusal. In particular, the following rights are enshrined in law:
No person may undergo any medical testing or treatment without their informed consent. This means that the person is entitled to information on the test before they give their consent to the test. Pre-test counselling must be done before HIV testing;
A parent or guardian must consent on behalf of a child under the age of 14;
A person who is 14 years of age or older may consent to HIV testing. Where children are able to consent on their own they must be given the test results and this information may not be given to their parents without consent;
Every person is entitled to confidentiality regarding medical treatment or testing. HIV test results may not be disclosed to any other person without the consent of the patient; and,
HIV test results may not be used to determine a person’s HIV status if this information is to be used to discriminate against them.
3.1 HIV testing and counselling
Rapid tests to detect antibodies to HIV can enable health providers to supply definitive negative and preliminary positive results to clients at the time of testing. Rapid testing allows people to be counselled, tested and given test results in a single visit. This is particularly useful in rural areas where returning for test results may be costly and difficult.
3.2 Diagnosis of HIV infection
In some clinical situations, it may be critical to have a rapid HIV diagnosis so that immediate appropriate therapy can be provided. For example, a patient may present with signs and symptoms of pneumonia. A delay in treating pneumocystis carinii pneumonia in a previously undiagnosed HIV patient may be life threatening. In these situations the immediate medical management of a client may be influenced by whether the patient is HIV infected or not. Rapid testing may be appropriate and more cost effective when compared to formal laboratory testing. This may be applicable in various clinical settings including health facilities providing antenatal care, management of sexually transmitted diseases, tuberculosis, or in patients with clinical signs that may suggest HIV infection.
3.3 Diagnosing HIV infection in areas without local diagnostic laboratories
In some isolated areas, diagnostic laboratories are often far away. This may result in delays in submitting specimens or obtaining results. Rapid testing in these situations can facilitate the diagnosis of HIV infection in health facilities where laboratory facilities are unavailable.
3.4 Occupational exposure to blood or body fluids that may be infected with HIV
Current national guidelines recommend the immediate use of antiretroviral (ARV) post exposure prophylaxis in the event of selected occupational exposures to blood and body fluids. Rapid diagnosis of HIV infection in the source patient can help to decide whether ARV should be instituted.
3.5 Epidemiological surveillance and other screening
Rapid HIV tests may be useful for epidemiological purposes such as for unlinked surveillance of HIV.
4.1 ‘Home test kits’
Some companies may market rapid HIV tests as ‘home test kits’ or ‘self testing kits’ to the public through pharmacies and other consumer outlets. The indiscriminate use and availability of home test kits is discouraged for several reasons including:
Current regulations require that pre and post test counselling must accompany all HIV testing which may not be available at home; and
High illiteracy levels in many communities may lead to incorrect test administration and results. Some individuals may not understand the test and may misinterpret the results.
Until these and other issues are resolved the Department of Health does not recommend that people conduct testing at home without the necessary pre and post HIV test counselling and support.
4.2 Performing and Interpreting Rapid Test Results
Rapid tests are not necessarily easy to perform or interpret. Adequate training and experience is necessary before health care workers use these tests. Quality control procedures should be instituted to ensure that test kits are stored and conducted in a proper manner. Strict stock control should also be instituted to ensure that test kits are properly accounted for.
4.3 Predictive value of rapid tests in low HIV prevalence communities
Where HIV prevalence is very low, the positive predictive value (probability that a test result predicts whether a person is truly infected) of the test is diminished resulting in a higher chance of obtaining false positive results.
4.4 Confirmatory HIV Testing
A confirmatory HIV test is recommended for all patients who test positive on the rapid test. Confirmatory tests are not necessary if the test result is negative or if there are signs of immune deficiency (oral thrush, Kaposi Sarcoma. PCP etc.) A different HIV rapid test, standard EIA, or Western Blot test can be used for confirmation.
5.1 Implications for health care workers, counsellors, and patients
A positive HIV test has far reaching implications for any individual. Rapid HIV testing should not imply quick patient management. Health care workers and counsellors must ensure that HIV testing is done within the accepted norms and standards of proper patient care. Pre and post HIV test counselling is required for persons undergoing all HIV testing regardless of the testing method.
Rapid testing can place pressure on health care workers, counsellors and on clients. There may be concerns that rapid testing may not provide clients with time to assimilate HIV test result information. The HIV and AIDS and STD Directorate will develop national guidelines on HIV counselling including the special considerations surrounding rapid HIV testing. Health facilities implementing rapid HIV testing should utilise these guidelines to develop protocols for same day counselling and testing.
If an initial rapid HIV test is positive, a confirmatory rapid HIV test using a different test should be performed. If the second test is positive, the client may be given the result. If the second test is negative (discrepant results from the first test), then a venous blood sample can be sent to the laboratory for a confirmatory HIV test. In the event of discrepant rapid HIV rest results the counsellor should arrange for a formal laboratory confirmatory test and schedule a return visit for the client to get the confirmatory result. The counsellor should verify the patients contact details (address, telephone number, etc) in order to ensure that the patient can be contacted.
6.1 The HIV and AIDS and STD Directorate recommend that a quality assurance process be implemented to evaluate, and monitor test kit performance and to ensure that suitably trained personnel use approved kits. Trained personnel should be monitored to ensure that the test kits are used correctly. Policies on which tests should be performed by formal laboratories, non-laboratory personnel, and home testing will be developed. Until the necessary regulations are formulated for laboratory test assurance the following process will be adhered to regarding rapid HIV tests.
6.2 Applications for the registration of HIV tests must be directed to Ms WH Maritz, Deputy Director Medical Devices, Directorate of Medicines Administration, tel: 012 312 0389.
6.3 Only tests approved and validated by the National Institute of Virology (NIV) or by other specified institutions will be recommended for use or for consideration for tender purposes.
6.4 Evaluations of rapid tests must be carried out by the NIV or by other specified institutions at the cost of the applicant and by arrangement of the applicant with the appropriate institution.
6.5 Use of specific rapid tests in the public sector must be decided in consultation with NIV or another specified laboratory.
6.6 The Directorate of Medicines Administration in consultation with the HIV and AIDS/STD Directorate will develop specific regulations and specifications for Rapid HIV test tendering.
6.7 The Directorate of Medicines Administration will make recommendations to the Pharmaceutical Association concerning the marketing of rapid tests to the public.
6.8 It is recommended that until further notice, home test kits or ‘over the counter HIV test kits’ not made available to the public unless prescribed by a doctor or mental health professional and accompanied with pre and post-test counselling.