FDA EUA CE Approved COVID-19 IgM/IgG Antibody Rapid Test Kit by Assure Tech Box of 20 or 25

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The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology that is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general, antibodies can be detected 1-3 weeks after infection. This test is intended to screen patients for COVID-19. Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals.

Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals, and birds that cause respiratory, enteric, hepatic and neurological diseases. Four viruses – 229E, OC43, NL63, and HKU1 are prevalent and typically cause common cold symptoms in immunocompromised individuals. Three other strains SARS-CoV, MERS-CoV, and SARS-CoV-2 (COVID-19) are can be transmitted from between non-human vertebrates to humans.

Warning

  • This test has been authorized by the FDA under a 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 the 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.

Read: Clinical Trial Summary of COVID 19 IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma)

FACT SHEET FOR HEALTHCARE PROVIDERS

See the diagram below and detailed COVID rapid test instructions available here.

ECOTEST for COVID-19 Antibody

WARNING: This Coronavirus COVID-19 rapid test not been reviewed by FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 (COVID-19) infection or to inform infection status.

This test is FDA approved for professional use during the SARS-CoV-2 pandemic according to FDA Emergency Use Authorization. The test is recommended for medical professionals use in medical offices and/or laboratories.

FDA authorizes this test for POC use using fingerstick blood samples. This authorization means that fingerstick blood samples can now be tested in POC settings like doctor’s offices, hospitals, urgent care centers, and emergency rooms rather than having to be sent to a central lab for testing.

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1 review for FDA EUA CE Approved COVID-19 IgM/IgG Antibody Rapid Test Kit by Assure Tech Box of 20 or 25

  1. doloresrn@aol.com
    5 out of 5

    Great tests Our clinic uses these rapid testing kits for employees and patients.Results are available in 10-15 minutes with very high accuracy. In my experience we had false positive results less than 1 percent.

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ECOTEST rapid antibody test for SARS-COV-2

ECOTEST by Assure Tech

Assure Tech.(Hangzhou) Co., LTD.

Assure Tech (Hangzhou) Co., Ltd was established by senior experts of in-vitro diagnostics industry in 2008. As a high-tech biotechnology company, Assure Tech is specialized in research & development, production, sell of diagnostic reagents, POCT and biological materials.

At present, the company has 6,000 square meters of R&D and manufacture base which contains the advanced level of colloidal gold diagnostic reagents production lines with annual production capacity of hundred millions of devices.

Currently, Assure R&D team has more than 100 staff who builds an extensive cooperation with the advanced domestic and foreign research institutions. And in domestic, Assure tech includes an advanced level in the rapid diagnostic reagents area, rapid molecular diagnostic area, the development and preparation of antibody, small molecular antigen synthesis and genetic engineering. What’s more, Assure Tech is committed to R&D in vitro diagnostic reagents area and related products: colloidal gold rapid detection reagents, Quantitative determination of chemilumineseent immunoassay reagent and bioactive materials. More than 100 products in 8 series are developed successfully which contain the following tests: pregnancy test, DOA test, infectious disease test, tumor markers test, cardiac markers test, food safety test, biochemical reagent series test, integration of instruments and reagents.

The Assure Tech products are sold to more than 100 countries and regions, such as Europe, Asia, Africa, Oceania and so on. Especially the drug detection reagent which has won a wide praise and owned more than 60% market share in some European countries.