HANGZHOU ALLTEST BIOTECH CO., LTD recently announced that it has successfully obtained the European CE OTC certification for its COVID-19 Antigen Rapid Test (oral fluid) intended for self-testing. This is a rapid chromatographic immunoassay designed to qualitatively detect SARS-CoV-2 nucleocapsid protein antigens in human oral fluid.
The test is specifically developed for home use, allowing individuals suspected of having COVID-19 to collect their own oral fluid samples. Its key advantages include ease of use (simple specimen collection), speed (results available within 15 minutes), simplicity (no additional equipment needed), and high accuracy. However, it's important to note that this test provides only a preliminary result. Any positive findings should be confirmed through further clinical diagnostics, while negative results must be interpreted alongside the patient’s exposure history and symptoms.
A clinical evaluation was conducted by comparing the outcomes of the COVID-19 Antigen Rapid Test against RT-PCR results. The study involved 406 oral fluid samples and showed 99.3% specificity and 90.1% sensitivity, resulting in an overall accuracy rate of 97.0%. The actual accuracy might fluctuate depending on the prevalence of the virus in different populations.
ALLTEST continues to offer comprehensive solutions for diagnosing COVID-19, providing various reliable rapid tests—both antigen and IgG/IgM antibody tests. Based in the Hangzhou Economic and Technological Development Zone in mainland China, ALLTEST remains committed to delivering timely and effective testing options.
As someone who has been following developments in rapid testing technologies, I find this advancement particularly exciting. It could significantly enhance accessibility to at-home testing, empowering people to take proactive steps in managing their health. I hope this new product helps reduce the burden on healthcare systems while ensuring accurate and efficient diagnosis for those in need.
Fire Hydrant,Fire Extinguishers,Fire Pipe Fittings,Fire Sprinkler Heads
Zhengzhou guan hao yong International Trade Co., , https://www.homepipes.com