Assure ECOTEST COVID-19 IgG/IgM Rapid Test 25 tests per box

$599.00

Coronavirus (COVID-19) Update: FDA Authorizes First Point-of-Care Antibody Test for COVID-19

Point-Of-Care Testing
CLIA Waived & FDA Authorized

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. The test is for Point Of Care professional use only.

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.

This product is FDA Authorized.
FDA Authorization Letter: FDA Letter

Product Insert: View or Print Here

Product Non-Refundable, Non-Returnable
For Medical Professionals
Not for consumer or at home use
CLIA Waived Number to Purchase Required

Category:

Please Provide your Medical License Number when you order. We will also request for a scan of your Medical License.

Coronavirus (COVID-19) Update: FDA Authorizes First Point-of-Care Antibody Test for COVID-19

For Immediate Release:

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for COVID-19. The Assure COVID-19 IgG/IgM Rapid Test Device was first authorized for emergency use by certain labs in July 2020 to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection. Today, that EUA is being reissued to authorize the test for POC use using fingerstick blood samples. This authorization means that fingerstick blood samples can now be tested in POC settings like doctor’s offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab for testing.

The COVID-19 IgG/IgM Rapid Test Device is an in vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 lgM and anti-SARS-Cov-IgG in human whole blood, serum or plasma. The test is for professional use only.

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