The NanoSpot.ai SARS-CoV-2 Total Antibody Test is an agglutination assay intended for semi-quantitative detection of total antibodies to SARS-CoV-2 in human venous blood (heparin and EDTA) and fingerstick whole blood.

The NanoSpot.ai SARS-CoV-2 Total Antibody Test is completed within 3 minutes from sample to answer.

Anyone can be tested with the NanoSpot.ai SARS-CoV-2 Total Antibody Test.

The test can be performed by healthcare professionals in a laboratory environment or in an office-like near-patient testing environment.

Indeterminate/Equivocal/Borderline? Borderline results indicate that the result does not fall within the proven measurement interval of the test. Ensure you are following the tilting instructions within the app and Instructions for Use and test another sample later after one to two weeks. Empty Spot? An empty spot failure is returned due to a sample missing in one of the spots. Repeat the test using a new test card ensuring blood and reagent are applied to each of the test spots following the directions provided in the Instructions for Use. Insufficient Light? The image provided was too dark to analyze. Repeat the test using a new test card in proper lighting following the directions provided in the Instructions for Use. Classification Error? One or more of the test spots could not be classified. Repeat the test using a new test card following the directions provided in the Instructions for Use. Positive Control Failure? Positive control failures are caused due to an insufficient amount of agglutination within the positive control spot. This is usually caused by insufficient tilting. Repeat the test using the tilting method described within the Instructions for Use. Negative Control Failure? Negative control failures are caused due to too much agglutination being present within the negative control. This is usually caused by a mix-up of reagents applied to the card. This could also be caused by unknown factors in the patient's blood which cause them to be non-ideal candidates for an agglutination assay. Repeat the test using the methods described within the Instructions for Use.

Capture images in a well-lit room. To reduce glare, avoid locations where lights are directly over the sample during capture. Avoid casting obvious shadows on the card.

The SARS-CoV-2 Total Antibody Test has a sensitivity of 98.0% and a specificity of 100%. The precision of the test across the various antibody concentration levels is shown below:

The capillary tube is constructed to automatically collect blood and dispense blood by squeezing the bulb. To properly collect blood, hold the capillary tube horizontally and touch the blood with the tip of the blood. Blood will automatically be drawn until the fill line. Do not squeeze the bulb or tube while collecting blood and ensure that enough blood is collected until the fill line. To disperse the blood sample gently squeeze the bulb. If the sample won’t expel the blood was not collected all the way to the fill line. Touch the blood sample with the tip of the capillary tube again and fill the tube up all the way to the fill line and then dispense.

The NanoSpot.ai SARS-CoV-2 Total Antibody Test utilizes an agglutination-based assay coupled with an artificial intelligence system enabled by the NanoSpot.ai Mobile Application to provide semi-quantitative total antibody results.

While antigen tests detect the virus itself, antibody tests look for antibodies in your blood that your immune system produced in response to the virus or vaccination against the virus.

The NanoSpot.ai SARS-CoV-2 Total Antibody Test utilizes an agglutination-based assay coupled with an artificial intelligence system enabled by the NanoSpot.ai Mobile Application to provide semi-quantitative total antibody results.

The NanoSpot.ai SARS-CoV-2 Total Antibody Test provides semi-quantitative antibody results whereas lateral flow tests only provide qualitative test results. The NanoSpot.ai test provides results in under 3 minutes from sample to answer whereas lateral flow tests generally take 10-20 minutes for answers. The NanoSpot.ai test readout is objective (using image/ AI-based test interpretation), while the lateral flow assay readout is subjective (based on visual interpretation).

The NanoSpot.ai approach generates results in under 3 minutes from sample to answer. Additionally, the NanoSpot.ai test only requires a fingerstick sample instead of a full blood draw.

The NanoSpot.ai SARS-CoV-2 Total Antibody Test is not intended for self-testing.

The test is designed to detect antibodies against the receptor binding domain of the original SARS-CoV-2 wild type.

The NanoSpot.ai Application does not transmit any of the patient’s identifiable information. All patient information is stored locally on the phone with their test result and can be deleted at any time.

Follow all facility and local guidelines on the handling of sharps and biohazard materials.

The app is suitable for the following phone models: 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 not been validated for use on a tablet.

The patient report can be downloaded, printed, and sent from within the NanoSpot.ai App once a result has been generated. To download, email or print the report click on ‘ View PDF Version’ displayed at the bottom of the patient’s result page. The PDF version of the report can then be saved, sent, or printed by clicking on the share icon in the upper right-hand corner of the screen. Follow your institution’s policies regarding data protection when downloading or transmitting the report.

Once the image is uploaded, the test result should appear within 30 seconds. If the test results do not appear within that time frame, please check your internet connection. If the problem persists please contact us at info@nanospot.ai.

The NanoSpot.ai SARS-CoV-2 Total Antibody Test is CE Marked and is available in territories that accept CE Mark. The test has not received FDA authorization or clearance and is not currently available in the United States.

Please contact us at info@nanospot.ai.