On May 13, 2022, COVID-19 Antigen Test Kit For Saliva (Dry Color Latex Immunoassay) self-testing product officially obtained the CE2934 self-testing certificate certified by the EU notified body! The test kit uses the principle of immunochromatography to detect the antigen N protein of the SARS-Cov-2 virus in human saliva samples. It can be used for home self-testing of COVID-19 antigens.
In response to the global outbreak of the COVID-19 epidemic, our company has successively developed COVID-19 testing solution, including the COVID-19 antigen (nasal swab) rapid test, the COVID-19 antigen (saliva) rapid test, etc., to comprehensively help the global COVID-19 epidemic prevention and control.
On April 25, 2022, Lansionbio COVID-19 Antigen Test Kit - nasal swab ((Dry Color Latex Immunoassay) self-testing product obtained EU IVDDCE1434 self-testing certification.
The test kit can be used for patients with suspected COVID-19 to collect nasal swabs for operation within the first 7 days after the onset of symptoms.
The European Centre for Disease Prevention and Control (ECDC) has warned that the Omicron strains BA. 4 and BA. 5 could lead to a significant increase in cases in the EU in the coming weeks and months, and we expect the epidemic to become a "protracted war". As the first line of defense in the comprehensive anti-epidemic system, COVID-19 test products are expected to be normalized as well. Therefore, it is extremely important to optimize scientific and reliable prevention and control strategies such as the discovery, screening, and inspection of the COVID-19.
At this stage, the test of COVID-19 mainly uses throat swabs to obtain nasopharyngeal mucus for viral nucleic acid detection. This is because the pharynx tends to accumulate more viruses, and the detection rate of throat swabs is high. However, taking throat swabs can cause discomfort, induce coughing or sneezing, and requires specialized operations, which cannot meet the increasing demand for rapid testing.
A growing number of researchers are studying the viral content in saliva to determine whether saliva can be used as an alternative source to detect SARS-CoV-2 infection. Most studies have confirmed that large amounts of the virus can be detected in saliva. Based on this, Japan has first approved the detection of the COVID-19 virus by saliva on June 2, 2020, and then a large number of European countries announced the use of saliva to detect the COVID-19 virus.
Lansionbio COVID-19 Antigen Test Kit -saliva/nasal swab (Dry Color Latex Immunoassay) is suitable for people with symptoms in suspected early (window period) of COVID-19 infection, and can have saliva / nose swab samples collected for operation to directly reflect the virus infection. It has the advantages of no need for professionals, venues and instruments; no discomfort to users; fast speed, etc., which is convenient for personal and families to conduct home testing for COVID-19.
The "CE" mark is regarded as the passport for the manufacturer to open and enter the European market.
Through unremitting efforts, Lansionbio has continuously improved the sensitivity of the reagents and obtained the EU CE certification, indicating that the company has passed strict technical review and met the clinical experiment requirements of clinical institutions, the product safety and clinical performance meet the international technical indicators, and obtained the local qualification of relevant importers. These two products have passed the requirements of the relevant EU market testing regulations, and can be legally marketed in 27 EU member states and countries that recognize EU CE certification.
The saliva test kit further enriched the COVID-19 detection solution, and expanded and met the needs of testing and control at all levels of the global market. Lansionbio will always uphold the corporate mission of "pursuing excellence, sincerely care for every life and health", constantly show to the world the brand strength of independent research and development and innovative development, and contribute Chinese strength to building a global anti-epidemic firewall!