Rapid tests are not endorsed by the FDA or other competent authority: Health


Neither the Federal Drug Administration (FDA) or the World Health Organization (WHO) nor the Pan american Health Organization (PAHO) and ni countries such as Germany or Canada have to apply, or use rapid tests to identify the coronavirus that causes the disease COVID-19, as has been speculated, said Wednesday the undersecretary of Prevention and Health Promotion, Hugo López Gatell.

In recent days, the governor of Jalisco, Enrique Alfaro, said in interviews with the media that the state had resolved the provision of two types of tests, a rapid response and other antigen to detect antibodies, which would be complementary to those that currently have validated and recognised by the Institute of Diagnostics and Reference Epidemiology (InDRE).

Alfaro said the two tests were validated by the FDA (the Foundation of Food and Drug Administration ) and by the international authorities. After the tests were not used in the state of Jalisco, by a cancellation of the supplier, according to the governor.

In the evening lecture on COVID-19, Lopez-Gatell said that there is a confusion in the issue of the rapid tests.

“It has been said in the media and on social networks that Germany was using rapid tests and that as a result he had a good control of epidemic, and the pressure was strong, began the questioning of why Mexico does not use rapid tests. We are overloaded with emails from companies and intermediaries that they say to use rapid tests”.

Before this, the official explained that they established contact with the German authorities to corroborate the information.

“We talked with the Robert Koch Institute, which is the authority on infection control and surveillance epidemic in that country, and the director of this institute, we verified that Germany does not use rapid tests and has not recognized any quick test as useful for this epidemic.”

Lopez-Gatell said that it was also said that the FDA had authorized a quick test, “we talked with leaders of the FDA and they confirmed to us that they have not accredited any quick test for the coronavirus of this epidemic. We did the same thing with the National Microbiology Laboratory in Canada and not the usa”.

On the other hand, said the undersecretary, the PAHO and the WHO have published, and is available for about three days, a positioning technician who says that at this point no competent health authority in the world has accredited rapid tests. “Mystery solved, there are no rapid tests useful at this time”.

On the rapid test which was presented by the president of the united States, Donald Trump, Gatell explained that this product is not a quick test.

“Not to confuse, what he presented is a product that technologically it is identical, in terms of the mechanism of the test that is the chain reaction of the polimeraza, the standard diagnostic that uses Mexico and the majority of the countries”.

This test is done in a laboratory, it can be done with a small portable computer, a sample of secretion of respiratory and makes a processing on the extracted genetic material from the virus and a process of chemical synthesis is multiplied when it reaches a certain number of copies, becomes detectable. “This is a test that identifies components of the virus”.

The quick tests, in contrast, explained López Gatell are not in laboratories; they are similar to the pregnancy test, is a test strip that has a component that changes color when it detects a certain signal, in this case, the antibodies generated by the human body against the virus.

However, he added, for the new coronavirus has not yet been sufficiently studied the response of the immune system to be able to isolate the components that allow recognition of these antibodies.

Therefore, he stressed, “it is not that we have a resistance-to-use rapid testing, but if you are not competent we cannot use them.”

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