over the counter hiv test

Over The Counter Hiv Test

The concept of HIV over the counter tests has been debated for years, in fact as long as HIV testing has been prevalent, however, it has not been endorsed widely. Recently, the argument on over the counter testing has again been sparked, with the USA FDA approval of OraQuick – an oral testing kit. By giving an opportunity for individuals to test themselves privately and conveniently, such tests might give those who are currently not reached by current HIV counselling and testing services the information on their HIV status. The present article reconnoiters over the counter HIV tests, their functioning, where are they available, their accuracy and acceptability, and the implications of the different test results.


Over the counter HIV tests, also termed as self-tests, enable individuals to test themselves for HIV at their homes, without the presence of a healthcare professional. It is a process wherein an individual who wishes to know his/her HIV status accumulates a specimen, undertakes the test and construes the test outcomes in private. There are several HIV quick diagnostic tests, however, at present, only one RDT (rapid diagnostic test) especially packaged for over the counter testing has the approval of the Food and Drug Administration of the USA. Majority HIV RDTs are oral fluid based or blood based tests that give results in half an hour. They identify HIV infection by recognizing the existence of antibodies that develop due to HIV exposure. The RDTs can’t be used immediately after the suspected infection as HIV has a window period of six to twelve weeks: the period between alleged HIV infection and the time when the test can spot HIV antibodies.

Though the RDTs considered presently for HIV testing are mainly oral fluid based and blood based, other alternatives for such self-testing are also proposed: for instance, RDTs using other kinds of specimen collation, simplified sampling mechanisms, painless or incorporated lancets, cohesive buffer delivery system and shorter maximum and minimum reading time.

The over the counter HIV assays do not give a definitive diagnosis; rather, it is a preliminary test to detect the existence of HIV-1/2 antibodies or the HIV-1 p24 antigen. In terms of precision, both Home Access HIV-1 Test and OraQuick are described by sensitivity and specificity. Sensitivity means the percentage of outcomes that will be positive when the virus is there, and specificity means the percentage of outcomes that will be negative when the virus is not present. The Home Access test is over 99.9% in terms of sensitivity and specificity but the test is only for HIV-1. The OraQuick has 99.8% specificity and 92% sensitivity for both HIV -1/2. The Oraquick is more effective at precisely identifying if a person is HIV negative than identifying if he/she is HIV positive. The FDA states that the probability of an HIV negative individual being incorrectly diagnosed as HIV positive by the test is only 1 in 5,000.


At mentioned above there are just two HIV tests available over the counter: the OraQuick In-Home HIV test, and the Home Access HIV-1 Test System. The price for either test ranges from $40 to $60 and they are available at various pharmacies and can also be purchased online. If the HIV test is purchased online, the buyer should ensure that it is FDA approved. It is noteworthy that both the tests are entirely anonymous which implies that the test results are associated only with a unique identifier, like a PIN number, and not the name or any other identifiable detail of the customer. Distribution of FDA approved HIV tests take place at myriad places within communities, including suitable venues and healthcare facilities. Facility initiated approaches enable customers to self-test in a private setting in a healthcare facility or at home.

Alternative venue based approach entails the public sale and distribution of the tests through convenience stores, pharmacies, vending machines and the Internet. Such open-access system is presently utilized in the USA. An alteration in this method may entail limiting access to the tests only to pharmacies, where they would be dispensed by pharmacists who are skilled at providing extra information and support regarding where to seek services for HIV care, prevention and support and test confirmation.


If the RDT of any person is reactive, it implies that the test shows that HIV antibodies have been found in the person’s oral fluid or blood sample. An individual who gets a reactive result to a rapid HIV test should undergo a second test for confirmation. This is a more precise test, which is carried out to confirm, or refute the outcomes of the rapid assay. The results of this confirmatory test take long to arrive and may at time take as long as 2 weeks. If the results of the second test also come back as positive, then the person ought to consult a doctor specializing in HIV treatment. Visits to the doctor should be regular to check the immune system. Unless the person has an advanced kind of HIV infection, such care is essentially aimed at preventing the infection from worsening. Individuals who are HIV positive should work closely with their doctors to determine when to begin the HIV medicines and what type of medicines to consume. The use of medicines for treating HIV infection is known as Anitretroviral Therapy (ART). It entails a mixture of HIV medicines each day. Though ART is not a complete cure for HIV, however, it assists the patients to lead healthier and longer lives and mitigates the likelihood of HIV transmission.


Though a negative HIV test result may be a huge relief for the person, but it may not always be correct. It depends on when the person may have been exposed to the virus and when he/she carried out the test. This is because of the window period – the time period after the person may have got exposed to HIV, but before the test could detect it. This window period relies on the kind of HIV test taken. For antibody tests, if the individual gets a negative result within three months of the latest plausible exposure, then the person ought to get tested again at the three month mark. If antibody/antigen tests are taken then this window period might be shorter. The healthcare professional must be consulted if and when the person needs to be retested after a negative result. In the meantime, he/she should practice abstinence or safe sex with a trustworthy partner. One should also remember that a negative outcome is good only for previous exposure. If they get a negative result, but continue engaging in high-risk behavior, then they are still vulnerable to HIV infection.


A false positive test implies that the result incorrectly shows that an individual is HIV positive when he/she is actually negative. This happens when the test wrongly detects a non-HIV antibody as an HIV antibody. This is a rare occurrence which takes place because antigens corresponding to those of HIV are spotted. A false negative on the other hand implies that the result wrongly displays that an individual is HIV negative when he/she is actually positive. A false negative appears when an individual is infected and does the test before the antibodies got the opportunity to develop sufficiently to be detected. This is likely to occur with OraQuick if a high-risk activity takes place within the 3-months window frame. This occurs because the test depends on the recognition of antibodies in the saliva, which might take nearly 90 days to develop. False negative may also happen if the user incorrectly reads the test as negative; or the instructions on test package are not carefully followed and the gum line is not swabbed by the user.

Over the counter testing technologies have the capability of reaching people at high exposure to HIV infection but who witness impediments to such tests in conventional facilities. Thus, if you suspect that you might have been infected but can’t visit a doctor’s office for a test or don’t want to do it for some reason, don’t hesitate to order a test online and learn your status.

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