The Omicron variant was discovered in South Africa and has now spread to many countries worldwide. On November 26, the World Health Organization officially classified Omicron as a "variant of concern".
This variant has been found to have about 50 mutations, including 32 mutations on the spike protein. With a high number of spike mutations in the area interacting with human cells and a larger contact area, experts warn that a COVID variant stronger than Delta in terms of transmissibility may have emerged. This new variant is also more resistant to vaccines and evades the body's natural immune responses.
Amid the emergence of many new COVID-19 variants, the United States Centers for Disease Control and Prevention (CDC) emphasizes that the COVID-19 self-test kit (also known as the home test kit or over-the-counter (OTC) test kit) is one of several risk reduction measures along with vaccination, mask-wearing, and social distancing.
Although the Omicron variant has significant mutations on the protein and may affect the sensitivity and specificity of rapid antigen test products, research by Quidel confirms that the QuickVue® At-Home OTC COVID-19 Test kit can still detect this variant.
According to information released by Quidel:
"At Quidel, we continuously monitor the evolution and activity of circulating COVID-19 variants, and the Omicron variant is no exception. Recent testing using live samples in South Africa has confirmed that our QuickVue® At-Home OTC COVID-19 Test and Sofia® SARS Antigen FIA are detecting the SARS-CoV-2 Omicron variant.
On December 22, 2021, the U.S. Food and Drug Administration (FDA) indicated that data generated in preliminary RADx laboratory studies, with heat-inactivated Omicron samples, suggest that QuickVue antigen tests can detect the Omicron variant with similar performance as with other variants. Additional testing has now been completed by the same laboratory using live virus. These data also indicate that QuickVue antigen tests can detect live Omicron variant with similar performance as with other variants."
The QuickVue® At-Home OTC COVID-19 Test kit produced by the manufacturer has the advantage of using a shallow nasal swab to avoid discomfort during testing, with high sensitivity and specificity, and provides results in just 10 minutes. Notably, this test kit can detect the Omicron variant.
The QuickVue® At-Home OTC COVID-19 Test kit imported and distributed by Medcomtech Joint Stock Company has been granted a circulation registration certificate by the Ministry of Health.
