Written by: Dr. Po-Chang Hsu, M.D., M.S.

Amplicon is pleased to announce that one of the tests we offer has been granted FDA Emergency Use Authorization during the COVID-19 pandemic. The EUA allows the public to gain access to diagnostic tests or treatments during an emergency, such as the COVID-19 pandemic we are currently experiencing, without going through the lengthy approval process.

The FDA has been collaborating with Centers for Disease Control and Prevention (CDC) and National Institute of Health (NIH) with its subdivisions National Cancer Institute (NCI) and National Institute of Allergy and Infectious Disease (NIAID) to valuate serological tests for developers. The evaluations include antibody tests that were not the subject of a EUA or pre-EUA and those that are under FDA review.

The National Cancer Institute (NCI) has released the testing results for the Helagen test offered by Amplicon. With the RT-PCR test as the gold standard, the results showed 97% sensitivity and 98% specificity with IgG, 100% sensitivity and 100% specificity with IgM, and 100% sensitivity and 98% specificity when combining IgG and IgM results.

NCI healgen covid test summary table

The high sensitivity and specificity results demonstrate that the serology test offered by Amplicon to be a leading screening tool for COVID-19 infection. The results also showed that the serology test could detect samples with dilution titer as high as 1:6400, showing excellent detection for even low concentration of SARS-CoV-2 antibody in the sample. Finally, the results showed there is no cross-reactivity between the serology test and serum samples positive for HIV, suggesting the test was highly specific for coronavirus.

As the United States begins to see positive impacts in mitigation efforts against the COVID-19 pandemic, the issue of how people can return to work and resume regular daily routines becomes a critical task for our nation. Serology tests, or antibody tests, can potentially play a crucial role in the evaluation of this process. Results from the serology tests can help identify individuals who have been infected and developed antibodies against future infection and individuals who are still at risk. You can view EUA Authorized Serology Test Performance data here, which includes findings for the Healgen Scientific lateral flow test as well as other antibody detection devices and methods.

The antibody test results can also help to identify individuals who may qualify to donate blood that can manufacture convalescent plasma, an investigational treatment for patients seriously ill with COVID-19. Click here to order the Healgen COVID-19 testing kit, or please contact Amplicon.

Click here to download the full study