Epitope Diagnostics has proudly introduced immunoassay kits exclusively for the qualitative detection of COVID-19. These kits include The EDI™ Novel Coronavirus COVID-19 IgG ELISA Kit and EDI™ Novel Coronavirus COVID-19 IgM ELISA Kit. With proven results from clinical testing in China, Epitope Diagnostics, Inc. is eager to cooperate and collaborate to combat the current COVID-19 situation.
The 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 other 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). It has been suggested that the spike protein has 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 specificity and sensitivity and pose risks related to specimen collection and sample handling. Epitope Diagnostics, Inc. has developed a solution to minimize these risks by using IgG and IgM ELISA kits. IgG is the most abundant immunoglobulin to be produced in response to an antigen and is maintained in the body after initial exposure for long term response. IgM is the first immunoglobulin to be produced in response to an antigen and is primarily detected during the early onset of disease.
The EDI™ Novel Coronavirus COVID-19 IgG and IgM assays utilize a microplate-based enzyme linked immunoassay (ELISA) technique, an established technology and industry standard in diagnostics. The assay procedure is simple to perform with a two-step plate wash with a total incubation time of less than 2 hours for up to 91 samples per plate. Both IgG and IgM kits have already been used for clinical testing at multiple sites in China. Results show a 100% clinical sensitivity and 100% clinical specificity against 20 RT-PCR confirmed cases and 43 normal healthy donor specimen at a local CDC laboratory. 75% (15 out of 20) of the positive cases show a 3x higher OD value than the positive cut off value and 90% (18 out of 20) have a 2x higher OD value 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:
KT-1032, EDI™ Novel Coronavirus COVID-19 IgG ELISA Kit
KT-1033, EDI™ Novel Coronavirus COVID-19 IgM ELISA Kit
References:
CDC (2020). Transmission of Novel Coronavirus (COVID-19).
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