First HIV rapid test approved for the home

First HIV test approved for the home

05/07/2012

In the US, a home-based HIV test was approved for the first time by the relevant drug agency. Using a saliva analysis, people who suspect they have been infected with the virus, one „AIDS test“ carry out. Within 30 minutes tester should have clarity on whether an infection has taken place.

After 30 minutes of certainty
Whether pregnancy test, blood pressure measurements or blood sugar test, numerous test products allow today, regardless of a visit to the doctor to obtain certainty. From October this year in the US also a HI virus test called „OraQuick In-Home HIV Test“ to come in the market. The approval for this has the US Food and Drug Administration (FDA) the pharmaceutical company „OraSure Technologies“ already granted. In order to be able to carry out the rapid test, the affected person must remove saliva with the help of a swab stick. The stick is then placed in a tube containing a solution. In order to get a result, then another 30 to 40 minutes have to pass.

HIV test showed a high error rate in studies
The HI virus test looks like a standard pregnancy test in which an additional cotton swab is installed. The health authorities point out, however, that the „HIV test has a high error rate“. During the admission procedure showed up, „that about every twelfth negative result was wrong.“ Accordingly, it may be that despite the indication „HIV-negative“ there is an infection with the dangerous AIDS virus. The positive results showed that every five-thousandth result is displayed incorrectly. The patient is despite signs of infection „HIV-negative“. Therefore, it is advisable, „in case of suspicion, have each result checked by a doctor“, said a spokesman for the FDA.

In drugstores and pharmacies, the test should be available from October onwards and without a prescription. A single self-test should cost according to the manufacturer about 36 US dollars. A pack of several test tubes should, according to the news agency „AfP“ about 60 US dollars or 47 euros cost.

No introduction planned in Germany
In Germany, there will be no AIDS self-test in the near future. In any case, the quality assurance officer at Deutsche Aids-Hilfe, Karl Lemmen, assumes this. In his view, such self-tests are not compatible to „sure to rule out an infection.“ The safety of correct results is just 93 percent for the drug. A test at the doctor only has an error rate of less than one percent. The development of such home testers have not progressed far enough to recommend these users. In addition, the „Starting position in the US not comparable with Germany“, explained Lemmen. Exist in the States „A five to eight times higher prevalence of infections and people without health insurance can not afford the medical examination“.

High dark figure of HIV-infected
The Robert Koch Institute estimates that around 73,000 patients in Germany live with a HI virus. Around 14,000 people do not know anything about their infection. However, such a test can hardly adequately correct the unreported number. For example, Armin Schafberger of the German AIDS Aid e.V. stated that such home-based tests do not replace a medical consultation. In addition, a negative result does not necessarily mean that there is no HIV infection. Because after a contagion can take up to three months, until the body has formed enough antibodies to detect an infection with such a test. Many people do not know this, but they are sufficiently informed by a doctor about this connection.

Since the year 2002 the pharmaceutical company Oraquick tries to design the product Marktreif. The test has already been used by doctors for ten years. For seven years, the US Food and Drug Administration (FDA) has been investigating whether a market release is eligible.

The „Human immunodeficiency virus“, in short form as „HIV“ denotes weakens the immune system of humans in different stages. A cure is still not possible, however, modern medicine can achieve a slowdown with drugs, so that the dangerous AIDS disease occurs late. AIDS leads to a steady decline in the immune system, which is why AIDS patients suffer from numerous complications.

In the US alone, around 50,000 people become infected each year. For example, around one fifth of the infected people do not know for years that they have become infected and thus continue to transmit the pathogen. Because so far in the US, no uniform health insurance exists, the test should reach those who shy away from the path to the doctor for cost reasons, as the manufacturer announced. On „One hundred percent test is not the product“, stressed the FDA. Anyone who gets a positive result, should definitely give to the doctor. Negative result, that is, if no infection is displayed, should be checked with a second test with a time delay. (Sb)

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