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Rapid Diagnostic Tests


Dear Prospective Client,

We understand that you may have questions about the use and registration of HIV rapid tests in your country, and we will try to clarify the situation and authorization process required to assist you and your company with this effort.

HIV devices (EIA and rapid tests) belong to the category III for the FDA medical devices; that means these products are highly regulated since they have to do with life and death. In fact the FDA issues Certificate for Exportability for such devices whether they are sold in the USA or not. The rapid HIV tests must be very sensitive – as sensitive as the ELISA tests; the difference between an ELISA test and a rapid test is that the first one is quantitative and the second one is qualitative. That is why the rapid HIV tests are used for screening purposes.

As I mentioned before, the rapid HIV tests must be as sensitive as the ELISA tests for instance, you cannot afford to have false negative results. But, how about false-positive results? Yes, you might have false positive results, that is, having a positive result in a patient who is not HIV positive. The reason for that is that some patients have autoimmune diseases, hyper-proteinemias, or hyper-gammaglobulinemias that render big amount of non-specific antibodies that stick to the membrane. To make myself clearer, every positive result rendered by a rapid HIV tests must always be confirmed with an ELISA test; if just one is positive, you must confirm your results with a Western Blot test (this is a requirement within the WHO guidelines).

Currently many countries are using HIV rapid tests and you may wonder how is that possible? To answer this question you may want to look at the following manuscripts issues by the FDA: “Exporting Medical Devices” (http://www.fda.gov/cdrh/devadvice/39.html ) and “Regulation of Medical Devices: Background Information for International Officials” (http://www.fda.gov/cdrh/manual/ireas.html). In brief, this is a summary contained in both manuscripts that might be of use to you:
1. HIV rapid tests can be imported into your country
2. The easiest way to import the HIV rapid devices are through a program via “Tier-1 Countries.”


Can you explain to me the significance of “Tier-1 countries? There are countries classified by the FDA as Tier-1 countries, meaning that those countries have a very good health system and, for instance, the FDA trusts their Health Ministry. RXGenesis ’s rapid HIV devices have been approved for sale in one of those Tier-1 countries (South Africa), so any other country can get a certificate for export –meaning import and sale of RXGenesis’s rapid HIV device- from the FDA for this specific product. These are the steps to follow:
1. RXGenesis will provide you with a copy of approval for sale in eg: South Africa for the HIV rapid device.
2. You have to go to the health ministry of your country, show them the copy
RXGenesis provided to you and
they will:
a. Accept RXGenesis’s copy and issue a letter stating that: i) the device is not in conflict with the laws of your country to import, ii) your Government (health ministry) has full knowledge of the status of the health device in the US, and iii) the import of the HIV rapid device is permitted or not objected.
b. They will probably want to test the HIV rapid device in their government health ministry facilities (run a comparative study or a clinical assay, etc.); for that matter they will most likely need 200-300 devices. Once the study is completed, your government’s minister of health will realize that
RXGenesis’s rapid HIV is excellent (already documented). Then they will issue a letter stating that your minister of health found our HIV rapid devices with the sensitivity and specificity they require. You will have to ask for an extra-letter stating that: i) the device is not in conflict with the laws of your country to import, ii) your Government (health ministry) has full knowledge of the status of the health device in the US, and iii) the import of the HIV rapid device is permitted or not objected.
c. You will have to send to
RXGenesis the originals, or certified apostil led letters; we will notify the FDA of your letter and you will be issued a “Certificate of Exportability” for the RXGenesis’s Rapid HIV device. That certificate of Exportability is the one required by your country to import and sell the device in your country, and,
d.
RXGenesis will start to ship you as many rapid devises as you need at very competitive prices with the guarantee that the rapid HIV device is as sensitive and specific screening device with results comparable to ELISA quantitative tests.

Gentlemen, we hope the above explanation is clear enough for you and that this explanation will help you to establish a fruitful business relationship with us at RXGenesis.

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