Epitope Diagnostics Has Proudly Introduced Immunoassay Kits Exclusively for the Qualitative Detection of COVID-19

The EDI™ Novel Coronavirus COVID-19 IgG ELISA Kit and EDI™ Novel Coronavirus COVID-19 IgM ELISA Kits. With proven results from clinical testing in China, Epitope Diagnostics, Inc. is eager to cooperate and collaborate to combat the current COVID-19 situation.

San Diego, CA, March 06, 2020 --(PR.com)-- 2019 Novel Coronavirus (COVID-19) is a single-stranded RNA coronavirus. Comparisons of the genetic sequences of this virus have shown similarities to SARS-CoV and bat coronaviruses. In humans, coronaviruses cause respiratory infections. Coronaviruses are composed of several proteins including the spike (S), envelope (E), membrane (M), and nucleocapsid (N). Results suggest that the spike protein retains sufficient affinity to the Angiotensin converting enzyme 2 (ACE2) receptor to use it as a mechanism of cell entry. Human to human transmission of coronaviruses is primarily thought to occur among close contacts via respiratory droplets generated by sneezing and coughing. There are over 90,000 confirmed Coronavirus cases globally with over 3,000 deaths as a direct result of the infection.

Effective detection of the Coronavirus is extremely critical. Currently, Real-Time Polymerase chain reaction (RT-PCR) tests detect genetic material to perform Coronavirus testing. However, these tests have low rates of sensitivity as well as presented many issues as a result of specimen collection and sample handling. Epitope Diagnostics, Inc. has a solution for these issues through IgG and IgM ELISA kits. IgG is the most abundantly found immunoglobulin to be produced in response to an antigen and will be maintained in the body after initial exposure for long term response IgM is the first to be produced in response to an antigen and will be primarily detectable during the early onset of the disease.

These assays utilize the microplate based enzyme linked immunoassay (ELISA) technique, a well established technology and industry standard. The assay procedure is very simple to perform with just two step plate wash and features a total incubation time of less than 2 hours. IgG and IgM kits have already been used for clinical testing at multiple sites for both assays in China. The data showed a 100% clinical sensitivity and 96.7% clinical specificity with 20 RT-PCR confirmed cases and 43 normal healthy donor specimen on a local CDC laboratory. There are 75% (15 out of 20) of the positive cases showing 3 times higher OD values than the Positive Cut Off value and 90% (18 out of 20) having 2 times higher OD values than the Positive Cut Off value. “The test excellently differentiates the COVID-19 confirmed cases from the normal subjects,” says Epitope Diagnostics' President, Ping Gao. "Our Research and Development team will continue to investigate new technologies that bring value to the new drug development and IVD community."

The EDI™ Novel Coronavirus COVID-19 IgG ELISA Kit and EDI™ Novel Coronavirus COVID-19 IgM ELISA Kit are available now. For more information, contact the Epitope Diagnostics customer service department at cs@epitopediagnostics.com or by telephone: +1 (858) 693-7877.

Product List:
1. KT-1032, EDI™ Novel Coronavirus COVID-19 IgG ELISA Kit
2. KT-1033, EDI™ Novel Coronavirus COVID-19 IgM ELISA Kit

1. CDC (2020). Transmission of Novel Coronavirus (COVID-19).
2. Chenjia Yuan, Shi Jinsong, Qiudong An, Liu Chang, Li Xin, Qiang, Ruanji Shou, mountains. Wuhan 2019 Bioinformatics coronavirus genome analysis [J / OL]. Bioinformatics: 1-10 [2020-02-10].
3. Fehr, A. R., & Perlman, S. (2015). Coronaviruses: An Overview of Their Replication and Pathogenesis. Coronaviruses Methods in Molecular Biology, 1–23. doi: 10.1007/978-1-4939-2438-7_1
4. Li, F., Li, W., Farzan, M., & Harrison, S. (2005). Structure of SARS coronavirus spike receptor-binding domain complexed with its receptor. doi: 10.2210/pdb2ajf/pdb
5. Wu, L.-P., Wang, N.-C., Chang, Y.-H., Tian, X.-Y., Na, D.-Y., Zhang, L.-Y., ... Liang, G.-D. (2007). Duration of Antibody Responses after Severe Acute Respiratory Syndrome. Emerging Infectious Diseases, 13(10), 1562–1564. doi: 10.3201/eid1310.070576
6. Xu, X., Chen, P., Wang, J., Feng, J., Zhou, H., Li, X., ... Hao, P. (2020). Evolution of the novel coronavirus from the ongoing Wuhan outbreak and modeling of its spike protein for risk of human transmission. Science China Life Sciences. doi: 10.1007/s11427-020-1637-5
Zhou, P., Yang, X.-L., Wang, X.-G., Hu, B., Zhang, L., Zhang, W., ... Shi, Z.-L. (2020). A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. doi: 10.1038/s41586-020-2012-7
Epitope Diagnostics, Inc.
Stefanie Lenart-Dallezotte