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
and has 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 combat
Coronavirus." |