Cov19 FluoBolt-DAT

The Cov19 FluoBolt-DAT (Duplex Antibody Test) assay is a metal enhanced fluorescence immunoassay (MEF-FIA) intended for the simultaneous quantitative detection of antibodies to the nucleocapsid- and the S1-receptor binding domain of SARS-CoV-2 virus in human serum and plasma. The Cov19 FluoBolt-DAT is for research use only and not to be used for diagnostic procedures.

Cov19 FluoBolt-DAT

The Cov19 FluoBolt-DAT is manufactured in Austria by Fianostics GmbH

Method: Metal Enhanced Fluorescence Immunoassay
Size: 1×96 wells
Sensitivity: 0.1 ug/mL
Dynamic Range: 0-40 ug/mL
Incubation Time: 1 hour
Sample Type: Serum, plasma
Sample Size: 10 µl
For Research Use Only

This platform is fully compatible to standard laboratory methodology using 96 well microtiter plate format and assays based on this technology can be run on any standard fluorescence microplate reader.


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 Spike (S) and nucleocapsid protein (NC), are the main immunogens of SARS-CoV-2. Antibodies against the RBD of the S protein 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 Cov19 FluoBolt-DAT (Duplex Antibody Test) assay 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 persist following infection or vaccination, and if the presence of antibodies confers protective immunity. Antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection or vaccination, although the duration of time antibodies are present post-infection or post-vaccination is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.

The Cov19 FluoBolt-DAT assay 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. The sensitivity of the Cov19 FluoBolt-DAT assay early after infection is unknown. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary. False positive results for the Cov19 FluoBolt-DAT assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes.

Documents

Product Manual