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EcoTest® COVID-19 Rapid Diagnostic Antibody Test Kit, FDA EUA Authorized, CE Approved, 20/Box

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SKU:
AZ COVID-19 P ECO
MPN:
AZ COVID-19 P ECO

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Below are the available bulk discount rates for each individual item when you purchase a certain amount

Quantity Per Item
1 - 5 $158.75
6+ $149.50
$158.75
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Description

ECOTEST® Coronavirus COVID-19 Antibody Test Kit (20 Tests/Box)

The 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.

  • Designed to identify individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
  • Results in minutes.
  • Detects virus in whole blood through fingerstick. Venous whole blood, plasma or serum can be used for lab application.
  • 95% confidence performance.
  • Cost effective at approximately 5% of the cost of a PCR test.

The COVID-19 IgG/IgM Rapid Test Device detects anti-SARS-CoV-2 IgG/IgM antibody through visual interpretation of color development. Anti-human IgG and anti-human IgM are used to detect specific antibodies in the human whole blood, serum, or plasma specimen. When specimen is added to the sample well, specific IgM and/or IgG antibodies, if present, will bind to the SARS-CoV-2 antigens conjugated to colored particles on the conjugate pad.

As the specimen migrates along the strip by capillary action and interacts with reagents on the membrane, the complex will be captured by anti-human IgM and/or anti-human IgG antibodies immobilized on the test region(s). Excess colored particle are captured at the internal control region. The presence of a red band(s) on the test region(s) indicates a positive result for the particular IgG and/or IgM antibodies, while its absence indicates a negative result. A red band at the control region (C) serves as a procedural control, indicating that membrane wicking is working.

FDA EUA + CLIA Waived

Laboratories with a CLIA Certificate of Waiver now authorized:

Use of this test with all authorized specimen types is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests.

This test is also authorized for use with point-of-care fingerstick whole blood specimens. For example; patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

EcoTest Antibody Health Canada Approved

NOW HEALTH CANADA APPROVED

The Assure Tech Ecotest has been authorized for sale by Health Canada.

This test is intended for use by trained healthcare professionals and not for home use or self-testing.

DETECTION WINDOW

Antibodies can be detected 5 to 7 days after symptoms first appear.

EcoTest Covid Antibody Detection Window

TEST PROCEDURE

EcoTest Covid Antibody Test Procedure

RESULTS INTERPRETATION

ECO Test Covid Antibody Results Interpretation

NEGATIVE
The coloured line in the control line region (C) changes from blue to red. No line appears in the test line regions M or G.
The result is Negative.

IgM POSITIVE
The coloured line in the control line region (C) changes from blue to red, and a coloured line appears in test line region M.
The result is anti-COVID-19 IgM Positive.

IgG POSITIVE
The coloured line in the control line region (C) changes from blue to red, and a coloured line appears in test line region G.
The result is anti-COVID-19 IgG Positive.

IgG and IgM POSITIVE
The coloured line in the control line region (C) changes from blue to red, and two coloured lines appear in test line regions M and G.
The result is anti-COVID-19 IgM and IgG Positive.

INVALID
Control line is still completely or partially blue, and fails to completely change from blue to red. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new cassette. If the problem persists, discontinue using the kit immediately and contact your distributor.

CLINICAL DATA

EcoTest Clinical Data Covid Antibody Test Results

This product is FDA EUA Authorized, CE Approved, Health Canada Approved

Product Non-Refundable, Non-Returnable

Contents: (20) Sealed Test Devices, (20) Assay Buffer, (20) Extraction Vials and Caps, (20) Specimen Collection Swabs, (1) Positive and (1) Negative Control Swabs , (1) Instructions for Use

Download EcoTest Documentation

PDF Download EcoTest Antibody Package Insert

PDF Download Assure Biotech EUA Letter

PDF Download EcoTest Antibody Provider Fact Sheet

PDF Download EcoTest Antibody Recipient Fact Sheet

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Additional Information

Per Each:
20
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