More about COVID Antibody Test

According to experts, there is a large range of applications for
serologic testing.
Novel Coronavirus
COVID-19 Antibody Test
Qualitative detection of the COVID-19 IgG and IgM in human serum
Antibody Testing for COVID-19
Advantages of coronavirus serologic
COVID-19 testing

As the country starts to see positive signs that the mitigation efforts, like stay-at-home orders and social distancing, are working in our fight against the COVID-19 pandemic, the question of when we can return to work and resume our normal
activities are one of the most critical issues facing our nation. Antibody tests – also known as serological tests – may have the potential to play a role in this complex calculation. Results
from these tests can help identify who has been infected and developed antibodies that may protect from future infection as
well as identify those still at risk. Results can also help inform who may qualify to donate blood that can be used to manufacture convalescent plasma, an investigational product for use with those who are seriously ill from COVID-19.

In the early days of infection, when the body’s immune response is still building, antibodies may not be detected, which
is why serological tests should not be used as the sole basis to diagnose or exclude infection with the

SARS-CoV-2 virus. (1)
IgG is the most abundant, and long-lasting, immunoglobulin to be produced in response to an antigen and is maintained in the body after initial exposure. IgM is typical, the first immunoglobulin to be produced in response to an antigen and is primarily detected during the early onset of disease.
Unlike a test designed to diagnose an active COVID-19 infection (the presence of SARS-CoV-2 virus), serological tests can help identify individuals who have developed an immune response to the virus, either as part of an active infection or a
prior infection. The tests detect the presence of antibodies in the blood. If specific antibodies are present, that indicates the person has been exposed to the SARS-CoV-2, most likely
developed antibodies against it. This may mean that person has, most likely, at least some immunity to the coronavirus. Further clinical evaluation, regarding long-term immunity and/or reinfection, is still under investigation.
POSITIVE NEGATIVE

How the Serological Tests Work
REFERENCES (1) Coronavirus (COVID-19) Update: Serological Test Validation and Education Efforts Commissioner of Food and Drugs - Food and Drug Administration Stephen M. Hahn M.D.
Serology can be used to complement the detection
of Molecular RT-PCR. It also increases the sensitivity
of the evolution of the infection.

It can help estimate the timing of infection. As knowledge develops about the immunity to potential reinfection of patients having previously contracted COVID-19
and recovered, antibody testing may provide information about statistically reduced contagion risks of and from these persons. It could help identify donors of plasma from recovered
patients that can be transfused into COVID-19 patients, as a potential treatment.

As the pandemic unfolds, serosurveys can closely track what percentage of the population has become infected, in each city or region. Serosurveys may also help efforts to develop vaccines and therapies.

The assays are an ideal supplement for direct pathogen detection and are a valuable tool for epidemiological studies. This test has been authorized by the FDA under their EUA
(Emergency Use Authorization).

Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be
considered to rule out infection in these individuals.
Results from antibody testing should not be used as  the sole basis for diagnosing or excluding SARS-CoV-2 infection or to inform infection status.
Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
COVID-19 ANTIBODY TEST
CODE SPECIMEN REQUIREMENT
TURNAROUND TIME
C480
1 SST