Assure COVID-19 IgG/IgM Antibody Rapid Test
This is NOT a test for active infection of Covid-19.
The Assure COVID-19 IgG/IgM Antibody Rapid Test (Whole Blood/Serum/Plasma) Rapid Test is a rapid lateral flow chromatography immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood, plasma from anti-coagulated blood or serum. The Assure COVID-19 IgG/IgM Antibody Rapid Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Each box contains 20 tests.
Authorized for fingerstick use only in-patient care settings operating under a CLIA Certificates of Waiver, Compliance, or Accreditation. This product can only be sold to healthcare facilities, practitioners, institution or qualified research or screening organizations. Testing is not for home use and is intended to be administered by a trained healthcare professional.
This test has been authorized by FDA under an EUA.
EC Declaration of Conformity. Fact Sheet for Health Care Providers. Fact Sheet For Test Recipient.
TEST KIT INCLUDES
- Testing Cartridge
- Alchohol Wipe
- Safety Lancet
- Capillary Pipette
- Complete Kit Buffer
- Simultaneous detection of IgG and IgM with control line to ensure test validity
- Room temperature storage or refrigerated (2-30°C / 36-86°F) when not in use
- Results compared to RT-PCR:
- Sensitivity: IgG 90.0%; IgM 100.0%
- Specificity: IgG 100.0%; IgM 98.8%
- Accuracy: IgG 97.3%; IgM 99.1%
- Fingerstick whole blood, venous whole blood, serum or plasma
- 9-Month Shelf Life
What is analyzed?
The Assure COVID-19 IgG/IgM Antibody Rapid Test is an immunoglobulin test which measures the level of types of antibodies in the blood. It measures Immunoglobulin G (IgG) which is the most common antibody. It also measures Immunoglobulin M (IgM). The Assure COVID-19 IgG/IgM Antibody Rapid Test is not a test to determine active and/or current Covid-19 infection.
DOWNLOAD FULL MANUFACTURER’S INFORMATION GUIDE AND DATA SHEET, CLICK HERE:
THIS COVID-19 IMMUNITY RAPID TEST KIT IS ONLY FOR THE INDICATION OF THE PRESENCE OF IgG AND IgM ANTIBODIES AGAINST SARS-CoV2, IT IS NOT ANY INDICATION OF ANY OTHER VIRUSES OR PATHOGENS, AND IT IS ONLY AUTHORIZED FOR THE DURATION OF THE DECLARATION THAT CIRCUMSTANCES EXIST JUSTIFYING THE EMERGENCY USE OF IN-VITRO DIAGNOSTICS FOR THE DETECTION 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 TERMINATED OR REVOKED SOONER. THIS COVID-19 IMMUNITY RAPID TEST KIT HAS BEEN AUTHORIZED BY THE FOOD AND DRUG ADMINISTRATION (FDA) UNDER AN EMERGENCY USE AUTHORIZATION (EUA) FOR USE BY AUTHORIZED LABORATORIES. THE PERSONAL USE OF THIS TEST HAS NOT BEEN EVALUATED OR AUTHORIZED BY THE FDA. THE STATEMENTS PROVIDED HEREIN HAVE NOT BEEN EVALUATED BY THE FDA. THIS COVID-19 IMMUNITY RAPID TEST KIT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT DISEASES. IF YOU HAVE A PHYSICAL OR MEDICAL CONDITION, YOU SHOULD SEEK THE ADVICE OF YOUR MEDICAL PROFESSIONAL IMMEDIATELY. IN THE EVENT THAT YOU USE THIS TEST, ITS RESULTS, AND/OR ITS INFORMATION FOR YOUR OWN HEALTH, YOU ARE PRESCRIBING FOR YOURSELF WHICH IS YOUR CONSTITUTIONAL RIGHT AND FOR WHICH THE COMPANY, GTX CORP., ASSUMES NO RESPONSIBILITY. THIS TEST, ITS RESULTS, AND/OR ANY OR ITS RELATED INFORMATION IS PROVIDED FOR EDUCATIONAL PURPOSES ONLY. THIS COVID-19 IMMUNITY RAPID TEST KIT IS NOT INTENDED TO REPLACE OR SUBSTITUTE FOR CONVENTIONAL MEDICAL CARE OR ENCOURAGE ITS ABANDONMENT.