Description
ECOTEST® COVID-19 Antibody Test Kit (20 Test 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.
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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. |
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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.
TEST PROCEDURE
RESULTS INTERPRETATION
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NEGATIVE IgM POSITIVE IgG POSITIVE |
IgG and IgM POSITIVE INVALID |
CLINICAL DATA
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 & Print Documentation
EcoTest Antibody Package Insert
