AssureTech EcoTest COVID-19 IgM/IgG Rapid Test Kit

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 Device is an in-vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum or plasma.

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

EcoTest is one of only a small number of COVID-19 rapid antibody tests that have both FDA Emergency Use Authorization and that detect two types of antibodies (IgM and IgG) - IgM peaks early in the disease and IgG peaks later during the illness. This combination provides broader capture of patients exposed to COVID-19. EcoTest performance was validated by a US physician-researcher and several of the box contents were enhanced as a result. There is no other COVID Rapid Antibody test like it on the market. EcoTest is for professional use only.

Features & Benefits

• Results in 15 minutes
• Easy to use and read
• Tests for both IgM and IgG antibodies
• Individually packaged kits for one time use
• Validated against RT-PCR results

Important Information

• This test has been authorized by FDA under an EUA for professional use.
• This test has not been FDA cleared or approved.
• This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
• This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
• This product is intended for professional use and not for home use.
• This product is not for the screening of donated blood.

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Important Links:

• Fact Sheet for Healthcare Providers
• Fact Sheet for Recipients
• Quick Reference Guide
• FDA Letter of EUA
• Instructions for Use (IFU)

This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.