IgG/IgM Rapid Test Kit
First Point-of-Care Antibody Test for COVID-19 Approved September 23, 2020, EUA authorized
As low as $6.49 in bulk
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Covid19 test in bulk
Drugtestincup is starting wholesale of COVID19 test in bulk. We are offering the lowest price on the market, so you can get the COVID19 test as low as $8.49. FDA Authorizes First Point-of-Care Antibody Test for COVID-19 Approved September 23, 2020, EUA authorized
This kit will provide everything necessary for the detection of IgM and IgG antibodies to SARS-CoV-2 in human blood. The test will provide results in as little as 15 minutes!
How does it work?
The Assure COVID19 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 a 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 particles are captured in 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.
Relative sensitivity: 93.7%
Relative specificity: 99.1%
Overall agreement: 97.7%
*95% Confidence Interval
Relative sensitivity: 98.8%
Relative specificity: 98.7%
Overall agreement: 98.7%
*95% Confidence Interval
- This test has not been FDA cleared or approved;
- This test has been authorized by FDA under a EUA for use by authorized laboratories;
- 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; and
- 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 the 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.
Covid-19 IgG/IgM Rapid Test Instructions for Use
Allow the test device, specimen, buffer, and/or controls to reach room temperature 59F-86F (15-30°C) prior to testing.
- Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.
- lace the test device on a clean and level surface. Note: There should be a blue line in the control region (next to “C”), discard the device if there is no blue line.
- Label the test with patient or control identification.
- Add the specimens. sing the provided disposable pipette, draw the specimen above the fill line (avoid the specimen entering the bubble of the disposable pipette) and transfer one drop of the specimen into the specimen well of the test device, then add 2 drops of buffer and start the timer.
- Wait for the blue line change to red line, read results at 15 minutes. Note: Specimens can also be applied using a micropipette.
Order now in bulk and save on your COVID test
For IgM detection:
|COVID-19 IgG/IgM Rapid Test||IgM+||74||2||76|
For IgG detection:
|COVID-19 IgG/IgM Rapid Test||IgG+||82||3||85|
04/09/2020: Lab Update: FDA Clarifies CLIA-waived Status for Point-of-Care SARS-CoV-2 Tests under Emergency Use Authorizations
Audience: Clinical Laboratory Professionals
Level: Laboratory Update
FDA Clarifies CLIA-waived Status for Point-of-Care SARS-CoV-2 Tests under Emergency Use Authorizations
The U.S. Food and Drug Administration (FDA) recently clarified that, when it grants an Emergency Use Authorization (EUA) for a point-of-care test, that test is deemed to be CLIA-waived. For the duration of the national emergency declaration for COVID-19, such tests can be performed in any patient care setting that operates under a CLIA Certificate of Waiver or Certificate of Compliance/Certificate of Accreditation.
In addition, FDA clarified that tests for SARS-CoV-2 that are offered prior to or without an EUA have not been reviewed by FDA, are not FDA authorized, and have not received a CLIA categorizationexternal icon. Thus, those tests are considered high complexity by default until they receive an EUA or other FDA approval that indicates they may be performed as moderate complexity or waived tests.
For more information, visit this FDA Web pageexternal icon, navigate to the section titled “General FAQs,” and view the first two questions and their corresponding answers.
- Clinical Laboratory Improvement Amendments (CLIA)
- Clinical Laboratory COVID-19 Response Weekly Calls
- CDC COVID-19 Information for Laboratories
- CDC COVID-19 Website
- Register for CDC Health Alert Network (HAN) notifications, including updates about COVID-19. Enter your email address to sign up.
Laboratory Outreach Communication System | Division of Laboratory Systems (DLS)
Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)
Centers for Disease Control and Prevention (CDC)