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Colombia already has the Elipse-COL, a blood serological test capable of detecting if someone who was in contact with Sars-CoV-2 generated antibodies and even if it was symptomatic or asymptomatic, a Colombian advance developed by researchers from the National University and the National Institute of Health (INS).
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Specifically, this test is based on blood from the suspect patient that is centrifuged to separate the solid part from the liquid. and thus obtain the substance known as plasma or serum, in which are the antibodies that could have been produced in the body in response to the virus.
This plasma is the one that analyzes the Elipse-COL test, which was a collaborative work with the National Institute of Health (INS), according to the researchers, who will publish the experimental data of this advance in number 8 of the journal Vaccine (2020) .
Adriana Arévalo, from the INS Parasitology Group and one of the researchers, explains that the Elipse-COL test detects memory immunoglobulin (IgG) antibodies and emphasizes that these usually appear between 10 and 30 days after infection.
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Scientists report that the specificity and sensitivity of this method is 91 percent and that so far more than 500 samples have been analyzed through it.
José Manuel Lozano, from the National Department of Pharmacy and a doctor in Chemistry, affirmed that these tests will be key in the seroprevalence studies that are being developed in 11 cities of the country and that seek to determine how many people had or were in contact with the virus. Martha Lucía Ospina, director of the INS, confirmed to EL TIEMPO that this test is now ready to be used in the aforementioned investigation.
The development
Ospina explained that For the development of this test, the genetic decoding of the virus circulating in Colombia made by the INS was taken as a basis. and from it, parts of structural components of the virus (peptides) were identified, which were later replicated in the laboratory.
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These parts, when in contact with the body’s defenses, produce defense reactions in the form of specific antibodies, which are the ones that are sought to be identified in the blood when performing the test.
In this standardization process, says Ospina, 34 sera were used from positive patients, including those from asymptomatic and symptomatic (mild and severe) and 68 negative sera, including some that were from before the pandemic but from arbovirus endemic areas or from people with a history of respiratory disease.
After the test was developed, the tests demonstrated a performance rated as very good, to the point that it detects reactivity in sera with a specificity of 91 percent, both in symptomatic patients and in people without symptoms.
In essence, this test is one of the serological tests that were initially called rapid tests, but in this case They have a national sanitary importance because it was elaborated based on the sub-lineages of the virus that circulate in the country and, in addition, it was standardized from our own analyzes.
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Being developed within a Colombian institutional context, it also guarantees sufficient availability, apart from having a significant impact on costs, the researchers said.
The professors of the National University say that this cooperative work had in their favor that the genetic code of the virus was known very quickly, given that only 12 days after the first case reported in Colombia, the INS had already revealed the first sequence of the circulating in the country.
This serological test will not be marketed to the general public and is intended to be used as part of the seroprevalence study.
Professor Lozano assures that in the world there are more than 1,700 reported genomes of the virus, of which 97 percent are identical, and although 3 percent may mean abundant mutations, this serological test is based on the identification of parts of the virus that have not been modified, that is to say that they are stable within the structure of Sars-CoV-2, which facilitates their identification.
Lozano explained that although there are two lineages of this virus in the world, 12 sublineages have been identified in Colombia, so it is essential to have diagnostic methods designed for “those local viruses, but also for the global genetic variants of the coronavirus”, which is achieved with these tests.
Finally, INS sources indicated that this serological test will not be commercialized to the general public and is intended to be used as part of the seroprevalence study and in specific populations.
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HEALTH UNIT