The EcoTest COVID-19 IgG/IgM Rapid Test Device is an in-vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum or plasma.
EcoTest has been validated by the FDA and found to have a 100% Sensitivity for IgM (30/30) and 98.8% Specificity for IgM (79/80). IgG Sensitivity was 90% (27/30) and Specificity was 100% (80/80).
EcoTest is one of only a small number of COVID-19 rapid antibody tests that have both FDA Emergency Use Authorization and that detect two types of antibodies (IgM and IgG) - IgM peaks early in the disease and IgG peaks later during the illness. This combination provides broader capture of patients exposed to COVID-19. EcoTest performance was validated by a US physician researcher and several of the box contents were enhanced as a result. There is no other COVID Rapid Antibody test like it on the market. EcoTest is for professional use only.
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Features & BenefitsResults in 15 minutes
Easy to use and read
Tests for both IgM and IgG antibodies
Individually packaged kits for one time use
Validated against RT-PCR results
This product is not for the screening of donated blood.
How it Works
EcoTest is a serology test. Serology tests use a patient's blood, serum, or plasma to identify the presence of IgM and IgG antibodies. Unlike PCR based testing, Serology testing provides rapid results in 15 minutes.
EcoTest is designed to detect antibodies (immunoglobulins, IgG and IgM) against the coronavirus (SARS-CoV-2). Antibodies are proteins produced by the immune system in response to a specific infection. They are found in the serum or plasma and develop approximately one week after an individual has been infected.
Antibody Test for IgG
This test detects IgG antibodies that develop in most patients within seven to 10 days after symptoms of COVID-19 begin. IgG antibodies remain in the blood after an infection has passed. These antibodies indicate that you may have had COVID-19 in the recent past and have developed antibodies that may protect you from future infection. It is unknown at this point how much protection antibodies might provide against reinfection. IgG peaks at 14-21 days.
Antibody Test for IgMThis test detects IgM antibodies. IgM is usually the first antibody produced by the immune system when a virus attacks. A positive IgM test indicates that you may have been infected and that your immune system has started responding to the virus. When IgM is detected you may still be infected, or you may have recently recovered from a COVID-19 infection.
IgM antibodies are produced by someone with an active COVID-19 infection on average around 7 days after infection, but as early as 4 days.
On average these antibodies disappear after about 28 days
LimitationsThe test is for in vitro diagnostic use only.
The test results of this kit are for clinical reference only. The clinical diagnosis and treatment of patients should be considered in combination with their symptoms/signs, medical history, other laboratory tests, and treatment response.
*DisclaimerAntibody tests cannot guarantee 100% accuracy as they are produced after a person has been infected. Because of this time window where acute inflections may be missed, clinicians should be advised to follow government guidelines for those exhibiting symptoms.
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.
This kit is for Professional-Use-Only.