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US regulators authorized this Tuesday the emergency use of the first rapid test to detect the new coronavirus, which can be performed entirely at home and shows results in 30 minutes – reported the Lusa agency.
The announcement by the FDA, the agency that regulates drugs and food in the United States, represents an important step in the country’s efforts to expand testing options for Covid-19. The United States is the country with the most deaths (247,229) and also with the most confirmed cases of infection (more than 11.2 million) by the new coronavirus, SARS-CoV-2, which causes covid-19.
However, the new test will require a prescription, which will likely limit initial use.
The device for rapid molecular testing
This is a molecular test, as explained in the site FDA, which means it looks for the presence of genetic material from the new coronavirus in samples. To do this, it amplifies the genetic material of the virus and requires the collection of samples from the nose using a swab, such as the much-discussed PCR (polymerase chain reaction) technique. But the result of the PCR technique takes hours to obtain, requires demanding laboratory processing and is more expensive.
The new technique now used in this rapid test is an alternative to PCR, called “isothermal amplification mediated by tie”- or LAMP, in the acronym in English. Ultimately, it amplifies nucleic acids, such as coronavirus RNA, but it does not depend on a succession of temperature cycles or a machine to do so (the thermal cycler), like the PCR technique. It operates at a constant temperature of 60 to 65 degrees Celsius, which results from the release of heat by chemical (therefore isothermal) reactions that take place within the device.
This is the first authorized test in the United States that can be performed by anyone at home, without requiring the intervention of medical personnel during its performance. Anyone over the age of 14 who is suspected of being infected with the virus can collect nose samples and be tested, on prescription. In those under 14 years of age, the samples must be collected by medical personnel in hospitals, offices or medical centers, where the test can also be applied to people of any age.
“This new test option is an important diagnostic advance to address the pandemic and reduce the public burden of disease transmission,” said Stephen M. Hahn of the FDA, quoted in a statement. “This authorization for a completely home test is a significant step in the FDA’s national response to COVID-19. A test that can be administered outside of the laboratory or in a medical setting has always been a high priority for the FDA in responding to the pandemic, ”added Jeff Shuren, also from the FDA. “Now Americans who may have COVID-19 can take immediate action, based on their results, to protect themselves and those around them.”
After 30 minutes, the result appears on the device indicated as “positive” or “negative” for SARS-CoV-2. If it is positive, the FDA also emphasizes in the statement, the person should isolate himself and contact the health authorities. “People who have a negative result and experience symptoms similar to those of COVID-19 should be monitored by health services, since a negative result does not exclude the possibility of infection by SARS-CoV-2,” he emphasizes.
