100% of omicron active virus samples with a maximum CT value of 21.59 (n=5) were detected in iHealth — COVID-19 Antigen Rapid Test.
On the evening of January 6, Jiuan Medical announced that On the evening of January 5, 2019, WE received AN iHealth — COVID-19 Antigen TEST OTC kit from THE RADx (Rapid Diagnostic Acceleration) Program of the National Institutes of Health (NIH) arranged by the Us Food and Drug Administration (FDA) Test) report on Test performance of Omicron variant virus. In this report, 100% of omicron active virus samples with a maximum CT value of 21.59 (n=5) were detected by iHealth — COVID-19 Antigen Rapid Test.
According to the announcement, the experiment took place on December 26, 2021, and the report was issued on January 4, 2022.
Jiuan medical has posted information on the FDA’s official website on December 28, 2021 on the effectiveness of its COVID-19 antigen test kit for the detection of omicron variant virus.
RADx recently conducted preliminary studies to evaluate the performance of some antigen tests in detecting live virus samples from infected patients, the FDA said. Early data suggest that the antigen test can detect the Omicron variant, but its sensitivity may be reduced. FDA continues to authorize the use of these kits as directed on the authorized label, and individual users should continue to follow the instructions contained in the kit products. Compared with nucleic acid tests, antigen tests are generally less sensitive and less likely to detect very early infection. In following the US FDA’s long-standing recommendations for rapid testing, it is important to confirm infection through subsequent nucleic acid testing if an individual has negative antigen test results but is suspected of novel coronavirus infection, for example if symptoms develop or there is a high probability of infection as a result of exposure.
Previously, Jiuan medical in shenzhen interactive platform said, in principle, believe that the company’s antigen detection products can detect the Omicron mutant strain. The company is now waiting for the arrival of the strain, and the laboratory is ready to test it as soon as it is available.
On December 24, 2021, the Shenzhen Stock Exchange issued a concern letter requesting Jiuan Medical to explain the basis for believing that the kit could detect the Omicron mutant strain. Explain whether there is any violation of the accuracy, timeliness and fairness of information disclosure, and whether there is any use of Interactive platform to cater to market hot spots and hype the company’s stock price.
On December 28, 2021, Jiuan Medical responded that the company has completed the comparison test of recombinant N protein with and without Omicron mutation through a third-party laboratory, and the test results of the two are basically no difference, which can theoretically be inferred the effectiveness of the company’s kit products in detecting Omicron virus. However, for the sake of scientific caution, after obtaining the virus strain, the product will be verified by test performance experiments to confirm the effectiveness of the product in detecting the virus strain. The company will make an official announcement when the experiments are completed and verification confirms that the Omicron variant is detectable.