Ecotest COVID-19 CLIA Waived Antibody Tests - IgG/IgM Rapid Blood Screen Cassettes
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Ecotest COVID-19 IgG/IgM Rapid Test Cassette - CLIA WAIVED
Results: 15 Minutes
Test: Ecotest COVID-19 IgG/IgM Rapid Test Cassette
Technology: Lateral Flow
Target: Professional Use Only
Quantity: 20 tests per box
The Ecotest COVID-19 blood cassette test is the very first designated CLIA Waived by the USFDA.
Call 727-744-2967 and we would be happy to discuss your testing needs.
For the product insert please click the icon below:
For the procedural reference card file please click the icon below:
The Ecotest COVID-19 IgG/IgM Rapid Test Device is a rapid lateral flow chromatographic immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. The Ecotest COVID-19 IgG/IgM Rapid Test Device is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Ecotest COVID-19 IgG/IgM Rapid Test Device should not be used to diagnose acute SARS-CoV-2 infection.
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 fingerstick whole blood specimens only 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.
Results are for the detection of SARS-CoV-2 antibodies. The IgG and IgM antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.
Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
The sensitivity of Ecotest COVID-19 IgG/IgM Rapid Test Device early after infection is unknown. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
False positive results for Ecotest COVID-19 IgG/IgM Rapid Test Device may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Due to the risk of false positive results, confirmation of positive results should be considered using second, different IgG or IgM assay.
The Ecotest COVID-19 IgG/IgM Rapid Test Device is only for use under the Food and Drug Administration’s Emergency Use Authorization.
TO ENSURE COMPLIANCE UNDER THE PREP ACT PLEASE BE AWARE OF THE FOLLOWING EUA DOCUMENTATION
COPY OF EUA https://www.fda.gov/media/139789/download
LETTER FOR HEALTHCARE PROFESSIONALS- https://www.fda.gov/media/139790/download
LETTER FOR PATIENTS- https://www.fda.gov/media/139791/download
INSTRUCTIONS FOR USE- https://www.fda.gov/media/139792/download
PROFESSIONAL USE ONLY:
PROFESSIONAL USE ONLY