Accu-Tell® COVID-19 IgG/IgM Rapid Test Has Got CE Registration in EU
1. Accu-Tell® COVID-19 IgG/IgM Rapid Test is for professional use. It is NOT for self-testing or home use;
2. Any distributor shall notify to your local authority about the product and get the appropriate approval before you import and place the product in your local market;
3. We are not marketing, selling, or distributing Accu-Tell® COVID-19 IgG/IgM Rapid Test without FDA clearance in USA.
On Mar. 11, the registration of our Accu-Tell® COVID-19 IgG/IgM Rapid Test Cassette with the German Competent Authority has been finalized and we got CE registration in EU for our COVID-19 IgG/IgM Rapid Test.
As of the reports on Mar. 7, the global number of confirmed cases of COVID-19 has surpassed 100 000. On Mar. 11, WHO characterizes COVID-19 as a pandemic.
The rapid and accurate point-of-care tests which perform well in field settings are especially useful if the test can be incorporated into presently commercially available multiplex respiratory virus panels. This would markedly improve early detection and isolation of infected patients and, by extension, identification of contacts. Rapid IgM and IgG antibody testing are also important ways to facilitate early diagnosis.
Accu-Tell® COVID‐19 IgG/IgM Cassette (Whole Blood/Serum/Plasma) products have been compared to a leading commercial product test using clinical specimens. The results show that relative to leading product tests, Accu-Tell® COVID‐19 IgG/IgM Cassette (Whole Blood/Serum/Plasma) shows 97.4% relative sensitivity and 99.3% relative specificity for IgG and 86.8% relative sensitivity and 98.6% relative specificity for IgM.
Now, we are ready to produce and deliver our Accu-Tell® COVID-19 IgG/IgM Rapid Test Cassette to our distributors worldwide. Let’s work together to fight against this pandemic on the principle of Early Identification, Early Isolation, Early Diagnosis and Early Treatment.
If you need any information about our products or any information about the disease, pls feel free to contact us.
“Once again, our key message is: test, test, test.”
Mar. 19, 2020