SARS-CoV-2 Rapid Antibody Test
Reliable, rapid, AI-based immunoassay to semi-quantitively detect antibodies against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Antibody levels from a finger stick within 3 minutes
The NanoSpot.ai SARS-CoV-2 Rapid Antibody Test is an agglutination based immunoassay intended for semi-quantitative detection of total antibodies to SARS-CoV-2 in human venous (heparin and EDTA) and fingerstick whole blood. The NanoSpot.ai SARS-CoV-2 Rapid Antibody Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection or vaccination. Total antibodies to SARS-CoV-2 are generally detectable in the blood several days after initial infection or vaccination.
Test kit information
This test kit is for HEALTHCARE PROFESSIONAL USE ONLY and allows users to obtain results via the NanoSpot.ai mobile application following the performance of an agglutination reaction.
All reagents and equipment necessary for performing the test, except a smartphone, are included in the kit and ready for use.
The test kit is manufactured in Utah. It has been CE Certified for the European market and is not available for US market at this time.
Each NanoSpot.ai SARS-CoV-2 Total Antibody Test Kit contains the following products:
SARS-CoV-2 Test Reagent Dropper Bottle
Calibrator Reagent Dropper Bottle
Negative Control Reagent Dropper Bottle
Positive Control Reagent Dropper Bottle
Blood collection capillary pipette
Package insert/Instructions for use: containing the full technical manual with instructions and further specifications
How Does The NanoSpot.ai SARS-CoV-2 Antibody Test Differ From Other Antibody Tests?
Rapid (under 3 minutes)
Accurate (98% sensitivity, 100% specificity compared the most sensitive reference laboratory test)
Semi-quantitative (calibrated to the WHO standard Version 2.0 of the NIBSC Anti-SARS-CoV-2 Diagnostic Calibrant (20/162) dated 24/05/2021.
No need of equipment of equipment (apart from a smartphone)
Results can be saved, shared, printed or integrated into EHR / EMR software
What Antibodies Does The NanoSpot.ai SARS-CoV-2 Antibody Test Detect?
Upon infection with SARS-CoV-2, the host mounts an immune response against the virus, including the production of antibodies against various viral proteins, such as the Spike protein, which mediates virus binding to a receptor on cells to initiate infection. Antibodies against the receptor-binding domain of Spike (Spike-RBD) as tested in the NanoSpot.ai SARS-CoV-2 antibody test, correlate particularly well with a strong neutralizing response. Accordingly, all current vaccines are based on the Spike protein. Measuring antibodies directed against the Spike protein, obtained either through natural infection or upon vaccination, can therefore provide a measure for immunity against SARS-CoV-2. While the COVID-19 antibody test cannot find out whether you are currently infected, the antibody test will provide information if your previously had the virus or a COVID-19 vaccine and how your body responded to a Covid-19 infection or the vaccine. In general, the higher the antibody levels, the higher the level of protection.
SARS-CoV-2 Rapid Antibody Test at a glance
results can be saved, shared, printed or integrated into EHR / EMR software
Capillary whole blood or venous whole blood (heparin or EDTA)
Version 2.0 of the NIBSC Anti-SARS-CoV-2 Diagnostic Calibrant (20/162) dated 24/05/2021.
Total antibody against SARS-CoV-2 Spike protein (RBD)
NEGATIVE PERCENT AGREEMENT
100% - in comparison to Siemens CIA reference lab test
POSITIVE PERCENT AGREEMENT
98% - in comparison to Siemens CIA reference lab test
kit contains everything required to run the test, except a smartphone for semi-quantitative results
none apart from Smartphone* for semi-quantitative results
3 minutes from fingerstick to result
Hemagglutination test coupled with objective AI-based readout and interpretation
*The following smartphones have been validated for testing. If other models are used, the mobile application may not load.
iPhone 13 Pro Max
iPhone 13 Pro
iPhone 13 Mini
iPhone 12 Pro Max
iPhone 12 Pro
iPhone 12 Mini
iPhone 11 Pro Max
iPhone 11 Pro
iPhone SE (2020 or 3rd Generation)
The NanoSpot.ai SARS-CoV-2 Total Antibody Test has been CE Marked.
The NanoSpot.ai SARS-CoV-2 Total Antibody Test has not been FDA cleared, approved, or authorized under an emergency use authorization.
The NanoSpot.ai Website may depict certain of our future planned care offerings which are subject to completion of development and may require regulatory authorization, clearance, or approval before they can be commercialized.