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COVID-19 ECOTEST Antibody fast Test Device

Individually packed.

Test cassette, alcohol prep pad, safety and security lancet, buffer and instructions for use included.

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AssureTech"s EcoTest COVID-19 IgG/IgM fast Test machine is an in-vitro immunoassay because that the direct and also qualitative detection that anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum or plasma.

EcoTest has actually been validated through the FDA and also found to have actually a 100% Sensitivity for IgM (30/30) and 98.8% Specificity because that IgM (79/80). IgGSensitivity to be 90% (27/30) and Specificity was 100% (80/80).

EcoTest is just one of only a small number of COVID-19 fast antibody exam that have actually bothFDA Emergency use Authorization and also that detect two varieties of antitoxin (IgM and IgG) - IgM peaks at an early stage in the disease and IgG peaks later during the illness. This combination provides broader capture of patient exposed to COVID-19. EcoTest performance was validated by a us physician-researcher and several the the box components were magnified as a result. There is no various other COVID rapid Antibody test like it ~ above the market. EcoTest is for experienced use only.

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Features & Benefits

Results in 15 minutesEasy come use and readTests for both IgM and also IgG antibodiesIndividually packaged kits for one time usage Validated versus RT-PCR results

Important Information

This test has been authorized by FDA under an EUA for skilled use. This test has not been FDA cleared or approved.This test has actually been authorized just for the existence of IgM and also IgG antibodies versus SARS-CoV-2, not for any type of other viruses or pathogens.This test is just authorized because that the duration of the statements that situations exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under ar 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.Positive results might be because of past or existing infection through non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.This product is plan for expert use and not for home use.This product is no for the screening the donated blood.