FDA Warns Omicron Can Negatively Affect Antigen Detection


FDA Warns Omicron Can Negatively Affect Antigen Detection

As of December 28, 2021, the FDA has updated how COVID-19 variants of concern (VOCs) impact the detection ability of listed molecular detection reagents. HymonBio has maintained its dynamic detection and can detect all variants, including Omicron. The FDA official website has warned that Omicron has developed more mutations than previous strains, especially in its S gene, which encodes the viral spike protein, highlighting the impact Omicron will have on molecular testing. After a preliminary analysis, the FDA has determined that the performance of certain EUA-authorized reagents may be affected by these mutations; it showed that some reagents were not expected to detect the Omicron mutation, and only SARS-CoV-2 Omicron mutations with specific gene deletion will be detected. Because of this, the FDA recommends that these tests should not be used until they are proven to be able to detect Omicron. Antigen testing and evaluation are still ongoing.

SARS-CoV-2 detection includes nucleic acid detection, antigen detection, and antibody detection. Due to the relatively low detection rate of antigen and antibody testing, current COVID-19 testing is focused on nucleic acid testing, now considered the “gold standard.” Its key characteristics are early diagnosis, high sensitivity, and high specificity. When viral antigen perforates the body, the body needs time for produce sufficient IgM and IgG; during this time period, antibodies cannot be detected in the serum, whereas nucleic acid can detect whether patients are infected. With limitations of “false negatives” and “false positives” in antigen and antibody testing, they are not suitable for large scale screening, nor for epidemiological investigation in low-risk areas.


HymonBio has adopted the “gold standard” for nucleic acid detection, and the innovative “one-step” method allows complete sample-to-results in 35 minutes. Combined with MoLock, nano-antibody molecular lock technology, and dual internal standard design, it achieves high sensitivity, high specificity, and monitors its own entire process; so far, there has been zero complaints worldwide. The Hymon® SARS-CoV-2 Test Kit has been verified by authoritative organizations such as the Clinical Testing Center of the National Health Commission of China, the Department of Microbiology and Devices of the US Food and Drug Administration, the King’s College Hospital NHS Foundation of the United Kingdom, and the Hong Kong Polytechnic University affiliated to the HongKong Department of Health. It can detect 100% of the variants of COVID-19, including Alpha, Beta, Gamma, Delta, and Omicron. At present, the test kit has been widely used in the United States, Europe, Asia, Africa, and other countries—more than half of the variant types detected in the United States are Omicron.

This COVID-19 test kit has passed quality evaluation of many clinical institutions, both in China and abroad, including: American Reference Laboratory, Kenya National Laboratory, Shanghai Clinical Testing Center, Jiangsu Medical Device Inspection Institute, etc., and has been approved by the US Food and Drug Administration EUA certification and the European Union CE certification, among many other national qualification certifications. It has been reported by more than 30 overseas media, and was cited by Dr. Stephan M. Hahn, current director of the FDA.

Post time: Dec-31-2021