Roche's new coronavirus antibody detection technology is authorized by the US FDA for emergency use
Comprehensive report by surging news reporter Cheng Tianmeng
On May 3, the Swiss pharmaceutical and testing giant Roche announced that the US Food and Drug Administration (FDA) issued an emergency authorization for its new Elecsys® Anti-SARS-CoV-2 new coronavirus antibody detection technology ( EUA).
According to the Wall Street Journal's report that day, Roche's detection technology can identify the new coronavirus antibodies produced by the human body, so as to determine whether the tester has been infected with new coronary pneumonia. For many diseases, antibodies remain in the blood for weeks, months, or even years after infection. Antibody testing is performed on blood samples, which is different from swab testing currently used to diagnose new coronaviruses.
Antibody testing is considered by many governments around the world as the key to better understanding the mild and asymptomatic transmission of new coronary pneumonia. However, so far, most of the tests that have been commercially available are not accurate enough. At present, the US Food and Drug Administration (FDA) has urgently approved about 10 antibody tests.
Roche said in a statement that its antibody detection technology, Elecsys® Anti-SARS-CoV-2, has a specificity greater than 99.8% and a sensitivity of 100% (14 days after infection confirmed by nucleic acid detection). The high specificity of this detection technique is essential to reliably determine whether the patient has been exposed to the virus and whether the patient has produced antibodies.
Antibody testing, also called serological testing, is used to determine whether a person has acquired immunity to a pathogen. The body produces antibodies in response to many diseases. In the current pandemic of new pneumonia, antibody detection needs to be able to specifically detect the new coronavirus (SARS-CoV-2) antibody, and can not cross-react with other similar coronavirus, otherwise it may produce false positive results, Thereby erroneously indicating the existence of immunity.
Based on the test results of a total of 5272 samples, the specificity of Roche's Elecsys® Anti-SARS-CoV-2 detection technology is 99.81%, which does not cross-react with 4 coronaviruses that can cause human colds, which means that it can reduce The probability of false positives due to similar antibodies that may exist in the individual. Elecsys® Anti-SARS-CoV-2 was able to detect antibodies with a sensitivity of 100% in samples collected 14 days after nucleic acid detection (PCR) confirmed infection.
Roche said the test can help assess the patient's immune response to the virus. As more and more is known about the immunity of the new coronavirus, this test may help to assess who has established immunity to the virus.
Roche also stated in the statement that the company has begun to send new antibody detection kits to the world's leading laboratories, and will further increase its production capacity to provide services for medical systems in countries that receive CE safety certification and the United States.