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.
20 Individually packed test devices
20 Alcohol prep pads
20 Sterile safety lancet
1 procedure card
1 Package insert
*External Negative and Positive Control sold separately.
Features and Benefits
• Rapid results in 15 minutes
• FDA EUA authorized CLIA waived finger stick whole blood IgM/IgG combination antibody test
• Small sample volume: only 5 µL of serum/plasma or 10 µL of whole blood
CPT Code: 86328
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IMPORTANT: Please refer to package insert (instructions for use) for more comprehensive product information.
|Catalog Number||Description||Units of Measurements|
|IDAZCOV19||Ecotest COVID-19 Antibody IgG/IgM Rapid Test Device (CLIA Waived, EUA) 20/Kit||Kit Box|
The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) product insert, authorized Fact Sheet for Healthcare Providers, authorized Fact Sheet for Recipients and additional studies are provided below: