FASTEP's RAPID COVID-19 TEST is the first antibody test authorized by the US Food and Drug Administration for use at point-of-care settings such as doctor’s offices, hospitals, pharmacies, urgent care centers and emergency rooms.
 
The 15 minute lateral flow test detects antibodies against the virus in venous whole blood, serum or plasma to help identify individuals with antibodies SARS-CoV-2 indicating recent or prior COVID-19 infection. 
 
The FaStep COVID-19 IgG/IgM Antibody Rapid Test can be used in a POC setting for rapid qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 via fingerstick whole blood without any additional special equipment.
 
FaStep 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).

FaStep 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/FaStep is for professional use only.

 How it Works 
FaStep 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.

FaStep 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 IgM 
This 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.

 Limitations 
The 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.

 *Disclaimer* 
Antibody 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. This test is authorized for use at the Point of Care (POC) and users must have a CLIA Certificate of Waiver.

 IMPORTANT INFORMATION 
This test is authorized for use at the Point of Care (POC) and users must have a CLIA Certificate of Waiver. This product is not for the screening of donated blood. This test is authorized for use at the Point of Care (POC) and users must have a CLIA Certificate of Waiver. 10 digit CLIA Certificate number must be provided to purchase.