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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)

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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.

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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

  • Test Cards

  • Alcohol wipes

  • Safety lancets

  • Blood collection capillary pipette

  • Mixing sticks

  • 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?

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  • Affordable

  • 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.

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SARS-CoV-2 Rapid Antibody Test at a glance

CONNECTIVITY

Results can be saved, shared, or printed

SAMPLE

Fingerstick blood sample

CALIBRATOR

Version 2.0 of the NIBSC Anti-SARS-CoV-2 Diagnostic Calibrant (20/162) dated 24/05/2021.

ANALYTE

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

EXTRAS

kit contains everything required to run the test, except a smartphone for semi-quantitative results

INSTRUMENT

none apart from Smartphone* for semi-quantitative results

TIME

3 minutes from fingerstick to result

FORMAT

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

  • iPhone 13 Mini

  • iPhone 12 Pro Max

  • iPhone 12 Pro

  • iPhone 12 Mini

  • iPhone 12

  • iPhone 11 Pro Max

  • iPhone 11 Pro

  • iPhone 11

  • 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.

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