BioMedomics: the test for antibodies to a coronavirus

Main article: Antibodies to COVID-19 coronavirus

2020

Turning of sales

In the middle of May, 2020 Becton Dickinson stopped sale of tests for antibodies to COVID-19 coronavirus because of low accuracy. Earlier it was supposed that this test will allow to reveal antibodies in only 15 minutes at the patient's bed.

The test developed together with BioMedomics was allowed to sale since March 26, 2020 provided that the company independently confirmed its accuracy. Regulators did not require from the companies to submit reports on results of validation therefore on the market more than 100 such tests got. It caused concern about their accuracy from specialists and independent scientists.

Becton Dickinson stopped sale of tests for antibodies to COVID-19 because of low accuracy

On May 4, 2020 the regulator changed the policy and asked the companies to confirm the accuracy of tests before sales. The companies which already brought tests to the market, a distance are 10 days old to provide information on check or to output inexact tests from the market.

The special subcommittee estimated the accuracy of tests for antibodies of BioMemodics company and three other American companies. The research conducted by scientists from the University of California in San Francisco, the University of California in Berkeley, Biohub and Innovative Genomics Institute brought to "extremely disturbing" to results. The chairman of subcommittee of Raj Raja Krishnamoorthi sent letters to UCP Biosciences, BioMedomics, Epitope Diagnostics and Premier Biotech and asked to provide messages of the regulator, results of internal check of tests, lists of receivers of tests and information sent to clients about tests.

In the statement of May 6 of Epitope Diagnostics disputed claims of subcommittee: Results of this research did not correlate with results of the clinical trials listed in the instruction for application of the test. Though we appreciate this initiative, researchers did not fulfill the requirement and did not follow the provided protocol presented in the instruction.

Meanwhile Becton Dickinson reported that BioMedomics already developed the test for antibodies of the second generation and now carries out validation tests.^[1]

Release of the test

At the beginning of April, 2020 BD (Becton, Dickinson and Company) issued the tests for detection of antibodies to a coronavirus confirming the flowing or postponed COVID-19 infection. The technology is developed jointly by biotechnology company BioMedomics and will come to serial production within April.

Unlike molecular tests which detect nucleinic acids or SARS-CoV-2 antigens the serological analysis reveals antibodies which the organism develops in response to a koronavirusny infection. Thus, serological diagnostics allows to identify people who already had an infection and developed to it immunity. Theoretically, these people could return for work or perform tasks with high risk of infection in vanguard of health care. BD claims that identification of antibodies can also help researchers to monitor spread of an infection of SARS-CoV-2 among the population.

Becton Dickinson issued the tests for detection of antibodies to a coronavirus confirming the flowing or postponed COVID-19 infection

To use serological researches thus, analyses which should be widely available, exact, fast and inexpensive are necessary — the American Enterprise Institute explained.

The BD-BioMedomics test allows to detect antibodies to a coronavirus of two types (IgM and IgG) within 15 minutes. BD reports that the test was clinically checked in several hospitals and laboratories both in the USA, and in China. According to the published data, the general sensitivity of the test is 88.66%, and specificity of 90.63%.

Though serological tests are less difficult, than molecular, they can be used only for identification of antibodies that limits their efficiency for diagnostics. For confirmation of an infection of COVID-19 first of all it is required to reveal antigens or virus SARS-CoV-2 DNA which are considered as the indicator of an active infection.^[2]

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