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COVID-19 IgG/IgM Rapid Test Cassette – FDA Emergency Use Authorized

COVID-19 IgG/IgM Rapid Test Cassette is a lateral flow immunochromatographic assay for the detection of SARS-CoV-2 antibodies in venous whole blood, serum or plasma. The COVID-19 IgG/IgM Rapid Test Cassette is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

COVID-19 (Coronavirus Disease) is the infectious disease caused by the most recently discovered coronavirus. This new virus and disease were unknown before the outbreak began in Wuhan, China, in December of 2019

EUA Authorized Serology Test Performance – Hangzhou Biotest Biotech RightSign COVID-19 IgG/IgM Rapid Test Cassette

  • Developer: Hangzhou Biotest Biotech
  • Test: RightSign COVID-19 IgG/IgM Rapid Test Cassette
  • Technology: Lateral Flow
  • Target: Spike
Statements And Conditions:
This test has been authorized by FDA under an EUA for use by authorized laboratories;
This test has not been FDA cleared or approved;
This test has been authorized only for the presence of lgM 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)(l) of the Act, 21 U.S.C. § 360bbb-3(b)(l), unless the authorization is terminated or revoked sooner.
This product is not for home use (Emergency Use Authorization – In Vitro Diagnostic Use Only)
Not for screening of donated blood

*PACKAGE INSERT AVAILABLE UPON REQUEST 972-800-6670

Independent Evaluations of COVID-19 Serological Tests

Serology tests detect the presence of antibodies in the blood when the body is responding to a specific infection, like COVID-19. In other words, the tests detect the body’s immune response to the infection caused by the virus rather than detecting the virus itself. In the early days of an infection when the body’s immune response is still building, antibodies may not be detected. This limits the test’s effectiveness for diagnosing COVID-19, and this is one reason serology tests should not be used as the sole basis to diagnose COVID-19. Serology tests could play a role in the fight against COVID-19 by helping healthcare professionals identify individuals who may have developed an immune response to SARS-CoV-2. In addition, these test results can aid in determining who may donate a part of their blood called convalescent plasma, which may serve as a possible treatment for those who are seriously ill from COVID-19. However, to use serology tests properly, it is important to understand their performance characteristics and limitations. Moreover, studies are underway to address questions that will better inform the appropriate use of these tests, such as whether the presence of antibodies conveys a level of immunity that would prevent or reduce the severity of re-infection as well as the duration for which immunity lasts.

Key Facts

  • Source of the data:Independent testing by US Government Laboratories

You should not interpret the results of this test
as an indication or degree of immunity or
protection from reinfection

This test detects human SARS-CoV-2 antibodies
that are generated as part of the human adaptive
immune response to the COVID-19 virus and is
to be performed on only human venous whole
blood (sodium heparin, EDTA, and sodium
citrate), serum or plasma (sodium heparin,
potassium EDTA and sodium citrate), and
fingerstick whole blood specimens.

Order COVID-19 IgG/IgM Rapid Test Wholesale or Bulk call 972-800-6670

Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500
(https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088

What is an EUA?


The United States FDA has made this test available
under an emergency access mechanism called an
Emergency Use Authorization (EUA). The EUA is
supported by the Secretary of Health and Human
Service’s (HHS’s) declaration that circumstances exist to
justify the emergency use of in vitro diagnostics (IVDs)
for the detection and/or diagnosis of the virus that
causes COVID-19.
An IVD made available under an EUA has not
undergone the same type of review as an FDA-approved
or cleared IVD. FDA may issue an EUA when certain
criteria are met, which includes that there are no
adequate, approved, available alternatives, and based
on the totality of scientific evidence available, it is
reasonable to believe that this IVD may be effective at
diagnosing recent or prior infection with SARSCoV-2 by
identifying individuals with an adaptive immune response
to the virus that causes COVID-19.
The EUA for this test is in effect for the duration of the
COVID-19 declaration justifying emergency use of IVDs,
unless terminated or revoked (after which the test may
no longer be used).

NHQ is committed to helping those in nursing homes or long term care. Please join us to help those who can help themselves. We are also working on related information like Rejection Sensitive Dysphoria in patients who suffer from covid so if you would like to participate please join our provider group.

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IgG versus IgM – COVID-19 IgG/IgM Rapid Test Cassette – FDA Emergency Use Authorized

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