Total SARS-COV-2 IgG (N, S1-RBD) Quantitative MEF-FIA (Dual Plate)
The Total SARS-COV-2 IgG (N, S1-RBD) Quantitative MEF-FIA is manufactured in Austria by Fianostics GmbH
Method: Metal Enhanced Fluorescence Immunoassay
Size: 1×96 wells
Sensitivity:
Incubation Time: 1 hour
Dynamic Range:
Sample Type: Serum, plasma
Sample Size: 20 µl
For Research Use Only
Background
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is a recently identified coronavirus strain responsible for the Coronavirus Disease 2019 (COVID-19) and pandemic. SARS-CoV-2 emerged in China in December 2019 and is transmitted mainly through droplets and surface contact routes. Symptoms can include signs and symptoms of acute respiratory illness, such as fever, cough, shortness of breath, but the infection can also be asymptomatic. The virus infects human cells through interaction with angiotensin-converting enzyme 2 (ACE2) on the surface of respiratory cells and spike (S) protein on the outer envelope of the virion particle, specifically with its receptor-binding domain (RBD). The S and nucleocapsid (NC) protein are the main immunogens of SARS-CoV-2. Antibodies against the RBD of the S protein (S1RBD) are considered to have neutralizing activity as they can block the interaction with the ACE2 receptor, thereby blocking cellular infiltration. Therefore, detecting antibodies against both proteins is a valuable tool for evaluating immunity against SARS-CoV-2 acquired through infection as well as vaccination.
The Total SARS-COV-2 IgG (N, S1-RBD) Quantitative MEF-FIA (Dual Plate) is intended as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection or vaccination. At this time it is unknown for how long antibodies in certain individuals persist following infection or vaccination, and what amount and type of antibodies confers protective immunity. The Cov19 FluoBoltTM-DUO SN assay should not be used to diagnose or exclude acute SARS-CoV-2 infection.
The Total SARS-COV-2 IgG (N, S1-RBD) Quantitative MEF-FIA (Dual Plate) should not be used to diagnose or exclude acute SARS-CoV-2 infection. Testing is limited to certified laboratories that meet requirements to perform moderate or high complexity tests.
Results are for the detection of SARS CoV-2 antibodies to the nucleocapsid and the S1-receptor binding domain of SARS-CoV-2. Antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection or vaccination. False-positive results for the Cov19 FluoBoltTM-DUO SN assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes.
The sensitivity of the Cov19 FluoBoltTM-DUO SN assay early after infection is unknown. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing by nuclear acid amplification tests (NAAT) for SARS-CoV-2 is necessary.
