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.
Clinical Performance
The performance of the Ecotest COVID-19 IgG/IgM Rapid Test Device evaluated at point of care (POC) sites is shown as the following:
Supporting Documents
Authorized Laboratories
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.
Safety Information
- For Emergency Use Authorization only
- For prescription use only
- For in vitro diagnostic use only
Disclaimers
- For use under an Emergency Use Authorization only
- For in vitro diagnostic use only
- This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by laboratories certified under CLIA, that meet requirements to perform moderate or high complexity tests.
- 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 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
- 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
- Results from antibody testing should not be used to diagnose or exclude SARS-CoV-2 infection or to inform infection status
- Not for the screening of donated blood
For information on the EUA, IFU, and purchase orders please contact your local sales representative or contact us at sales@lochnessmedical.com or 1-888-506-2658.
Product Information
- Product Code: COV-13C20E
- Sample: Venous Whole Blood / Serum / Plasma / Fingerstick Whole Blood
- Format: Cassette
- Time-to-Result: 15 minutes
- Storage Condition: 2 - 30°C / 35.6 - 86°F
- Test Principle: Lateral Flow Chromatographic Immunoassay
Contents
- Individually Packed Test Devices
- Disposable Pipettes
- Sterile Safety Lancet
- Buffer
- Package Insert
- Alcohol Prep Pad
- External Negative and Positive Control (Available upon request)