SA's ONLY APPROVED TEST FAQ
SOUTH AFRICA’S ONLY
HIV TEST APPROVED FOR PERSONAL USE
What does ‘approved’ mean?
In South Africa, as in all modern nations, there are regulations to protect the public especially with respect to health. It is the job of the South African Pharmacy Council (‘SAPC’) ‘to protect, promote and maintain the health, safety and wellbeing of patients and the public ensuring quality pharmaceutical service for all South Africans.’ As part of protecting the public, certain medicines and medical products that should not be used by anyone who isn’t a licensed medical professional are not approved for general consumer use.
Why is BioSure HIV Self Test approved and other HIV tests in South Africa are not?
BioSure has been subjected to the some of the most rigorous scientific and quality testing in the world. This is why it bears the ‘CE’ mark for a home test. It has been repeatedly inspected to make sure that not only is it of the highest quality with exceptional accuracy but also that an untrained individual would be able to use it without and risk to its effectiveness. Not only have all the parts of the kit been checked for safety and accuracy but even its instructions have been reviewed by numerous medical and consumer safety experts to make sure normal people are able to use it safely and accurately.
But I’m sure I’ve seen other HIV tests for sale in South Africa that have the CE mark?
It is possible you have seen HIV tests with a CE mark but those are FOR MEDICAL PROFESSIONAL USE ONLY. BioSure HIV Self Test has a CE mark for SELF TEST use. Currently there are no other APPROVED HIV self tests you can buy in South Africa.
BioSure also manufacturers professional grade tests for HIV and other diseases but it carefully controls its supply chain and wholesale relationships to make sure that only properly authorised and trained medical professionals have access to professional tests. Reputable manufacturers and distributors should not allow the general public to access professional grade medical supplies, drugs or diagnostic tests.
But surely it’s a good thing to use a professional grade test - it must be good quality?
No. The best thing that could happen is you’ve wasted your money, the worse thing that could happen is a serious risk to your own health or that of others.
If you are not a medical professional, you absolutely should not buy or use any test that is not approved from personal self test use for a number of reasons.
You cannot trust the results from a non-approved test. If you are not licensed and trained to use the professional grade test, there is a good chance you will not be able to use it properly and may get a false result. This may mean that you are failing to get life-saving medical attention you require or that you make important decisions based on totally unreliable information.
But is the only problem in not buying an approved test is that it’s ‘professional grade’ and I don’t know how to use it?
No. Some of the unapproved tests that unfortunately can still be found through certain outlets in South Africa are professional grade however there are other tests that are not approved in any manner, bear no CE mark either for professional use or for HIV Self Test use. These tests have not undergone rigorous examinations for quality. Even if used correctly, the quality and accuracy cannot be relied on. Furthermore, these tests may not have been stored in correct conditions so they may be damaged and also provide useless information. They may even have needles that are not sterilised which could cause infections and spread disease. They may even be counterfeit and absolutely worthless as HIV tests as well as dangerous to the users. It is not worth taking the risk. Only use an approved, CE-marked for self test use, HIV Self Test.
Is CE-marked for self test use the only way I can tell if an HIV test is okay to use if I’m not a medical professional?
It is certainly the easiest and safest way to be sure that you are not wasting your money or risking your health. In other countries, such as the United States, the Food and Drug Administration (FDA) is in charge of approving drugs and pharmaceutical devices. This is why the Global Fund which invests billions of pounds in fighting HIV/AIDS will only consider purchasing tests that are either CE-marked or FDA approved. However, there is currently not any other approved HIV self test available to purchase in South Africa.
I’ve heard that other companies may be bringing self tests into Africa – what about those?
There are certain companies that manufacturer self tests as well as professional grade-only tests (such as BioLytical who make the INSTI test) which have produced a cheaper and inferior ‘Africa-only’ test for the African market which are by the same brand but those tests are not CE-marked for self test use and have not been subjected to the same rigour as the BioSure HIV Self Test. BioSure sells only the same extremely high quality products to Africa as it sells in the UK, Europe and the rest of the world.
Are all of BioSure’s HIV Self Tests the same in every part of the world?
Yes. Unlike some other companies, BioSure believes that Africans deserve and need the same quality as Europeans and would never provide a watered-down version of its product to any consumer no matter what country they live in or background they come from. Different countries have different regulations about packaging and instructions, so BioSure complies with all the local requirements which means that sometimes there may be minor differences in packaging but all its tests are of the same high quality and have been subjected to the most rigours vetting to ensure their accuracy and appropriateness.
What should I do if I see a non-approved for self test use HIV test being sold to the general public?
Don’t buy it and warn your friends that it is dangerous. Complain to the Pharmacy Council. An online form can be found here:
A letter or complaint should be forwarded to the Registrar of the SAPC.
Postal address: Private Bag 40040, Arcadia, 0007.
Physical address: 591 Belvedere Street, Arcadia, Pretoria. Fax number: (012) 321 1479/92.
E-mail address: firstname.lastname@example.org
What should I do if I have already accidentally purchased a non-approved HIV test?
If you have incorrectly been sold a non-approved test but have not used it yet, take it back to the place of purchase and insist on a full refund and inform the merchant that you intend to make a complaint to the Pharmacy Council about about it. Go to www.hivselftest.co.za and purchase a properly approved HIV self test instead.
If you have been incorrectly sold a non-approved test but have used it, please don’t panic. The best course of action is for you to purchase an approved test to check your status for peace of mind. Remember HIV is just 3 letters, not a sentence. If you re-test and get a positive result you must have it confirmed by a licensed medical professional. Information about where to find your nearest medical professional is available on www.hivselftest.co.za.
If you are concerned that the unapproved test you used may have placed you at further risk, please visit your nearest medical professional.