COVID-19 Antibodies (IgG/IgM) Rapid Test

FDA EUA APPROVED

What is COVID-19 Antibodies Rapid Test?

The COVID-19 Antibodies IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology that is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM (early marker) and IgG (late marker) antibodies.

 

In general, IgM antibodies are formed initially by the patient at about the time that symptoms first appear. These antibodies will dissipate after about one month. IgG antibodies are second to appear in the body, about one week after symptoms appear. They will continue to be present in the bloodstream for a prolonged period of time.

 

Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals.

Why Antibodies Test?

The antibody test is helpful in many ways:

  • As many people who have COVID-19 infection show no or mild signs and symptoms of illness, antibody tests could be useful in determining if you had the virus without knowing. It could also help guide your doctor in making clinical decisions about your care.  

  • Antibody tests could also help determine individuals who qualify to donate convalescent plasma, a component of blood that contains antibodies. Convalescent plasma therapy uses blood donations from recovered patients to help treat others with COVID-19 infection. 

  • The antibody test is viewed as a key to help develop a vaccine for the virus.   The body’s response to a potential vaccine is directly correlated with the antibodies built by the body.

  • Many countries and communities around the globe have adopted widespread antibody testing to better understand the true infection rate and how deadly the virus is. This data will be helpful to predict how COVID-19 might affect us in the future, including why some people are more severely impacted than others. Finally, the antibody test results are also helpful in contact tracing to assess who else is at risk of infection and how far the disease spread. All of this data will help improve strategies to curb the COVID-19 pandemic. 

The antibody test is seen as a key to reopen the country, 

 

restart  the economy, and reintegrate society.

Benefits of Antibody test

Benefits of AntibodyTestDIAGNOX
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Features & Specifications

Format:

Time to results:

Specimen:

Volume:

Positive Percent Agreement:

Negative Percent Agreement:

Shelf life:

Storage:

Cassette

10 minutes

Whole Blood/Serum/Plasma

10 uL

IgG 96.7% | IgM 86.7% | Overall 96.7%

IgG 98.0% | IgM 99.0% | Overall 97.0%

 

24 Months

Room temperature or refrigerated (2-30⁰C / 36-86⁰F)

  • ​Facilitates patient treatment decisions quickly

  • Detection window (IgM): 3-5 days for Symptomatic. 7 days for Asymptomatic

  • No clinical equipment or facilities needed

  • Dual-band results for simple interpretation

  • Multivariable analysis of immunoglobin IgG & IgM

According to the new FDA policy, the serological antibodies tests can be used by “point-of-care” facilities, including laboratories, hospitals, clinics, physician’s offices, and where healthcare workers are involved in treating and/or testing patients. However, "results from antibody testing are presumptive and should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status".

Certifications and Approvals

Chinese FDA

Approval pending

FDA

US FDA

Emergency Use Authorization (EUA) Approved

Australia TGA

Approved

CE

CE-IVD Marked

Clinical Testing

Multiple clinical trials

conducted and

approved.

WHO Tested

The test has been registered with the FDA and can be sold under the Emergency Use Authorization (EUA) Program. The FDA allows the commercial distribution of the test for use by health care providers and laboratories while the test is being reviewed by the FDA. This is in accordance with the FDA policy on March 16, 2020, relating to COVID-19 testing. 

Watch The Testing Video

CONTACT

US

Contact us for any technical and sales queries.
Tel: (866) DIAGNOX
sales@diagnox.us

​Important  Disclaimers:

  • This test has been approved by the US-FDA under Emergency Use Authorization (EUA).

  • Negative results do not rule out SARS-CoV-2 infection, particularly in individuals who have been in recent contact with the virus. Follow-up testing with a molecular diagnostic test should be considered in order to rule out infection in such individuals.

  • Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform of infection status.

  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

  • This test is for use by medical professionals and does not apply to at-home testing.

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