FIRST FDA EUA AUTHORIZED COVID-19 Point-of-Care Rapid
antibody Test
PURCHASE NOW FDA EUA AUTHORIZED *CLIA Certificate of Waiver number required for purchase *This test is only approved in a Point-of-Care setting
HIGH ACCURACY 10 MINUTE Read
TESTING TIME
PURCHASE NOW *CLIA Certificate of Waiver number required for purchase *This test is only approved in a Point-of-Care setting
EASY TO USE NO EQUIPMENT
REQUIRED
PURCHASE NOW *CLIA Certificate of Waiver number required for purchase *This test is only approved in a Point-of-Care setting

mouse-goral

COVID-19 IgG/IgM Rapid Test

  • EASY TO USE
  • RESULTS ARE READ AT 10 MINUTE
  • HIGH ACCURACY
  • NO EQUIPMENT REQUIRED

BUY NOW!

*CLIA Certificate of Waiver number required for purchase.

*This test is only approved in a Point-of-Care setting

Application:

General Population Screening

  • Allows rapid examination

Hospitals, Physician Offices, Laboratories

  • Can screen carriers who are asymptomatic
  • Can help determine if patient recently affected by virus, even if virus is no longer present

Intended Use:

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 if for professional use only.

*CLIA Certificate of Waiver number required for purchase.

*This test is only approved in a Point-of-Care setting

  Principle:

The Assure COVID-19 IgG/IgM Rapid Test Device is a lateral flow immunochromatographic assay for the detection of SARS-CoV-2 antibodies in venous whole blood, serum or plasma. This test uses anti-human IgM antibody (test line IgM), anti-human IgG (test line IgG) and goat anti-mouse IgG (control line C) immobilized on a nitrocellulose strip. The conjugate pad contains recombinant SARS-CoV-2 antigen (antigen is recombinant Nucleocapsid Protein and Spike Protein (S1)) conjugated with colloid gold.

During testing, the specimen binds with SARS-CoV-2 antigen- conjugated gold colloid coated particles in the test cassette. When a specimen followed by assay buffer is added to the sample well, IgM &/or IgG antibodies if present, will bind to COVID-19 conjugates making antigen antibodies complex. This complex migrates through nitrocellulose membrane by capillary action. When the complex meets the line of the corresponding immobilized antibody (anti-human IgM &/or anti-human IgG) the complex is trapped forming a red line which confirm a reactive test result. Absence of a red line in the test region indicates a non-reactive test result.

To serve as a procedural control, a red line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

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.

COVID-19 IgM/IgG Rapid Test

Assure has developed and launched one of the world’s best rapid point-of-care lateral flow immunoassays to aid in the diagnosis of coronavirus infection. The test detects both early marker and late marker, IgM/IgG antibodies in human finger-prick (capillary) or venous whole blood, serum, and plasma samples. The COVID-19 IgM/IgG Rapid Test by Assure. demonstrates a combined sensitivity and specificity of 100% and ~99% respectively, making it one of the most accurate and reliable tests in the world.

BUY NOW!

*CLIA Certificate of Waiver number required for purchase.
*This test is only approved in a Point-of-Care setting

PRECISE

Works with whole blood, serum, & plasma
Tests for both IgM and IgG antibodies
Validated using PCR

FEATURES & BENEFITS

FAST

10-15 minutes read per test
Intuitive visual interpretation
No special equipment needed