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COVID-19 ECOTEST Antibody quick Test Device

Individually packed.

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

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

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

EcoTest is one of only a small variety of COVID-19 fast antibody exam that have actually bothFDA Emergency usage Authorization and also that recognize two types of antitoxin (IgM and IgG) - IgM peaks early in the an illness and IgG peaks later throughout the illness. This mix provides wider capture of patient exposed come COVID-19. EcoTest power was validated through a us physician-researcher and also several the the box contents were intensified as a result. Over there is no various other COVID fast Antibody test like it on the market. EcoTest is for skilled use only.

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Features & Benefits

Results in 15 minutesEasy to use and readTests for both IgM and IgG antibodiesIndividually packaged kit for one time usage Validated against RT-PCR results

Important Information

This test has actually been authorized by FDA under one EUA for expert use. This test has actually not to be FDA cleared or approved.This test has actually been authorized only for the visibility of IgM and IgG antibodies versus SARS-CoV-2, no for any other viruses or pathogens.This check is just authorized because that the expression of the declaration that situations exist justifying the authorization the emergency usage 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 together coronavirus HKU1, NL63, OC43, or 229E.This product is to plan for professional use and not for home use.This product is no for the screening that donated blood.