Abbott antibody test COVID-19 (SARS-CoV-2 IgG)

Main articles:

• Antibodies to COVID-19 coronavirus
• COVID-19 Antibody Tests

2021: Obtaining Rospotrebnadzor registration certificate for IgG II Quant

On April 1, 2021, Abbott announced the receipt of a registration certificate from the Federal Health Supervision Service of the Russian Federation for the serological test IgG II Quant for antibodies IgG to COVID-19. The test measures the amount of antibodies in the body and provides important information about the formation of protective immunity to infection, and also helps assess the patient's immune response to COVID-19 vaccination.

At the beginning of April 2021 in Russia, more than 4 million confirmed cases of infection with coronavirus infection. The country conducts mass vaccination based on the virus's spike protein, which is able to provide collective immunity to the disease and stop the spread of the disease. In this regard, the need for accurate investigation of the immune status of people is increasing among workers in the fields of health and science.

The spike protein of the virus plays an important role in how the virus enters cells. As the body provides an immune response, antibodies are produced that bind to the spike portion of the virus, preventing it from entering the cell and ultimately preventing infection. In order to induce the same immune response, most vaccines are being developed based on the spike protein of the coronavirus.

Abbott's quantitative antibody test IgG is designed to determine the amount of antibodies that have been produced to the virus's spike protein in the serum and blood plasma of patients infected with SARS-CoV-2.

The quantitative antibody test will IgG be performed on Abbott ARCHITECT i1000SR and Abbott i2000SR laboratory equipment.

2020

Abbott: our tests for COVID-19 antibodies cannot be trusted without another test

In early December 2020, Abbott released a newsletter in which it warned doctors that the company's tests for antibodies to coronavirus cannot be trusted without checking with another, independent test. US regulators have confirmed that Abbott's antibody test should IgG be supplemented by a validation study.

The letter, dated December 1, 2020, states that the U.S. Food and Drug Administration (FDA) agrees with an additional statement to Abbott's newsletter describing the risk of obtaining false positive results. FDA received Abbott warning on October 7, 2020.

Abbot said their tests for COVID-19 antibodies cannot be trusted without another test

The Abbott test for SARS-CoV-2 IgG at the time of a statement had 99.6% specificity and 100% sensitivity at the patients who passed test in 14 days after emergence of symptoms. As a result, Abbott received emergency permission to use its serological blood test on Architect analyzers in April 2020, and next month on its use in Alinity analytical systems.

Nevertheless the doctors using the Abbott SARS-CoV-2 IgG tests have to consider the possibility of confirmation of positive results by means of the second, independent antibody test.

Abbott Laboratories' test for coronavirus antibodies COVID-19 "demonstrates excellent analytical characteristics," researchers at the University of Washington wrote in the Journal of Clinical Microbiology.

A similar Abbott product test for the ADVIA series of immunochemical analyzers is being developed by Siemens Healthineers. Earlier in 2020, the German company developed a test for the total antibodies of classes IgM and IgG to detect antibodies to SARS-CoV-2 in the blood with specificity and sensitivity of "more than 99%," but the medical product has not yet received the rego-confidence of Roszdravnadzor.^[1]

Obtaining Roszdravnadzor certificate

On June 3, 2020, it became known that Abbott received the registration certificate of the Federal Health Supervision Service of the Russian Federation for its laboratory serological test to detect IgG antibodies, which allows you to determine whether a person has suffered coronavirus (COVID-19). Testing for antibodies is an important next step to understand whether a person was previously infected. This will allow a better understanding of the virus, including how long antibodies remain in the body and whether they provide immunity. This knowledge can help in the development of treatments and vaccines.

Abbott has focused on creating tests to help fight the pandemic. We are proud that we are ready to immediately put our antibody tests in Russia, which will help determine who has already suffered the virus and give confidence to steps towards a return to normal life, stated Stefano Paoloni, managing director of Abbott's diagnostics division in Russia.

Since the introduction of the test, the world's leading laboratories have studied and confirmed the high efficiency of the test. In the research published in the Magazine of Clinical Microbiology (Journal of Clinical Microbiology) it is established that the Abbott test for antibodies of SARS-CoV-2 IgG showed specificity of 99.9% to this virus and sensitivity of 100% for definition of antibodies of IgG at patients for 17 and more days after emergence of symptoms.

Antibody tests are designed to expand testing and help healthcare.

The test of the company Abbott, SARS-CoV-2 IgG, distinguishes IgG antibodies - proteins which the organism produces at late stages of an infection and which can remain up to several months and, perhaps, even years after recovery of the person. The test demonstrated specificity and sensitivity of more than 99% to antibodies IgG 14 days after onset of symptoms.

The Abbott antibody test will IgG be performed on Abbott's ARCHITECT i1000SR and i2000SR laboratory equipment. ARCHITECT is one of the laboratory systems that has been used for several decades. More than 500 such systems are used in laboratories throughout Russia. Each of them can perform up to 100-200 tests per hour.