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The Federal administration of Food and Drug (FDA, for its acronym in English) you will receive, in the next two to three weeks, the final results of a study that portrays the effectiveness of a test laboratory was created in Puerto Rico to measure the antibody COVID-19 in people who have been infected with the virus.
Two researchers in the Medical Sciences campus of the University of Puerto Ricodr. Ana Espino and the doctor Carlos Sariol, created the serological test that has already been tested in about 100 samples have been processed, achieving high effectiveness in their results.
“The idea came because we know the difficult situation that there is with the coronavirus and diagnostic measures (in the market). We decided to create a test of IgG and IgM,” said Hawthorn.
IgG and IgM are immunoglobulins or antibodies of a disease present in a person’s blood. According to the encyclopedia MedlinePlus, antibodies are proteins made by the immune system to fight substances that cause disease, such as viruses and bacteria. The IgM measured by an acute infection recent, and IgG, past infection.
As explained by Hawthorn, due to the pandemic of COVID-19, have been created many tests of the quick call, but have not been validated or certified. The FDA has granted authorization for the use of emergency (EUA, for its acronym in English) to some companies due to the crisis of health. None, however, has the express authorization to validate its effectiveness.
“Many of these tests give false positive or negative. For that reason, it continues to support in the diagnostic tests molecular,” said Hawthorn.
This week, the Department of Health reported that it would withdraw some serological tests of the company Pharmatech then the FDA negated its use. This occurs when the company does not request a U.S. or identify significant problems with the test.
The researcher explained that, as most of the kits for these tests are found in the possession of private laboratories, the idea emerged to create a local test.
“We took on the task of developing, in our laboratories, these trials (of tests), with results in an hour and a half. We optimize a few assays of IgG and now we are riding the IgM,” he said.
According to Espino, it is very difficult to be able to make diagnostic tests molecular to the whole population, including people with no symptoms of the virus. He cautioned, however, that the antibody tests if they allow you to do a screening mass of the virus.
As he explained, with the testing tool you are developing, you could be prosecuted from 40 to 80 samples at once, and get results in an hour and a half.
He anticipated that they are already giving service to Blood Banks and health care Center Mutual Services with the test of IgG antibodies to validate their results.
“We are having a 98.9 percent specificity and 96 percent sensitivity. There are few cases that we lose. All molecular tests positive give us equal and negative,” said Hawthorn.
The doctor added that currently there are only two such tests that have received the emergency use of the FDA, but none offered the test, and the methodology that created them.
Several weeks ago, doctors Hawthorn and Sariol received a grant (“grant”) of $100,000 of the Trust for Science, Technology and Research of Puerto Rico as part of a call for proposals to sponsor research related to the COVID-19.
In addition, through another proposal submitted to the University of Puerto Rico, received more financial assistance to expand its research and develop an epidemiological study.
As explained by Hawthorn, this other effort measures whether the antibody levels of people have already cured of COVID-19, who wish to be donors of plasma, which were able to neutralize the virus.
In a written explanation of his study, dr. Sariol stressed the importance of being able to identify people already cured of the virus to get a better idea of how many in Puerto Rico have been exposed to this disease (prevalence and incidence). Through the essay that is prepared, held, you will be able to tell to people already immune to the virus from other infected people. The methodology they use, anticipated, is the ELISA, a laboratory technique that identifies small particles and germs that cause diseases.
Until yesterday, Puerto Rico had been identified 3,397 positive cases, between molecular testing and serology.
What you should know about testing COVID-19
What are the tests of COVID-19, and what variety there is?
Are laboratory tests that help to detect the virus. There are two types of tests: viral or molecular and antibody or serological.
How do they measure these tests?
The viral indicate whether the person is infected with the virus. The antibodies reflect if the person has had an infection of this disease.
How many have been approved by the federal Administration of Food and Drug administration (FDA)?
None of the tests of COVID-19 has been approved by the FDA. Before the pandemic of this virus, it has issued an authorization of emergency use (USA, in English).
Do all the tests COVID-19 in the market have the authorization of emergency?
More than 70 companies have notified the FDA that are serological tests available, but not all of them have the authorization. The federal government has warned that it will take action against those who make a false claim.
What are some of the companies with the authorization of emergency of the FDA?
Between the FDA mentioned, are the following: Abbott Alinity i SARS-CoV-2 IgG Abbott Architect SARS-CoV-2 IgG, Autobio Anti-SARS-CoV-2 Rapid Test, Bio-Rad Platelia SARS-CoV-2 Total Ab, Cellex qSARS-CoV-2 IgG/IgM Rapid Test, Chembio Diagnostic Systems DPP Covid-19 IgM/IgG System, and the Roche Elecsys Anti-SARS-CoV-2.
How accurate are their results?
The effectiveness of these tests is measured by two factors: specificity and sensitivity. The specificity is the number of negative results in people who do not have the disease. The sensitivity is the number of test results positive.