FDA EUA COVID-19 Fingerstick IgM/IgG Antibody Rapid Test (EcoTest) by Assure Tech. Box of 20.

4.75 out of 5 Based on 4 ratings

$209.00$1,950.00

New

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 by AssureTech is authorized for use with fingerstick whole blood specimen at the point-of-care.

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).

Q-ty (boxes)1310
Price per box$209.00$199.00$195.00
Clear
Qty:

Each box of COVID-19 IgM/IgG Antibody Rapid Test (EcoTest) by Assure Tech includes 20 Tests:

  • 20 Covid-19 Antibody Tests Cassette
  • 20 Sterile Fingerstick Lancets
  • 20 Sterile Alcohol Pads
  • 20  Droppers for Blood Collection
  • 20 Vials with Buffer

The COVID-19 Antibody IgG/IgM (Whole Blood/Serum/Plasma) Rapid EcoTest 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.
  • EcoTest is intended for professional use and not for home use.

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

FACT SHEET FOR HEALTHCARE PROVIDERS

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

  • This test has not been FDA cleared or approved. This test has been authorized by the FDA under a EUA for use by authorized laboratories. It is a point of care test for
    fingerstick whole blood specimens only. The user should be trained in the procedure. Wear appropriate protective attire for your safety when handling patient samples.
  • 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
  • Read the complete Quick Reference Instructions before performing the test. For technical assistance, please call (800) 618-5829.
  • There should be a blue line in the control region (next to “C”) before testing, discard the device if there is no blue line.
  • Due to the risk of false-positive results, confirmation of positive results should be considered using second, different IgG or IgM assay.

AssureTech COVID-19 Antibody Test Kit Quick Reference

 

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.

Weight15 lbs
Dimensions6 × 6 × 4 in
Quantities:

1 Box of 20 Tests, 3 Boxes, 10 Boxes

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.