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COVID-19 Testing: Healgen Rapid Antibody Testing (IgG/IgM)

Features

  • Detection Window (IgM): 3-5 days after incubation 

  • Dual-band results for simple interpretation

  • Multivariable analysis of immunoglobin IgG & IgM

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

  • Procedural internal control included

  • Buffer included

 

Specifications

  • Clinical Evaluation

    • Positive Percent Agreement (PPA): IgG 96.7%; IgM 86.7%; Overall 96.7%

    • Negative  Percent Agreement (NPA): IgG 98.0%; IgM 99.0%; Overall 97.0%
       

  • Clinical Agreement with Characterized Samples

    • Sensitivity: IgG 96.7%; IgM 100%; Combined 100%​

    • Specificity: IgG 97.5%; IgM 100%; Combined 97.5%​
       

  • Specimen: Whole Blood, Serum, Plasma

  • Time to Results: 10 minutes

  • Shelf Life: 24 months from the date of manufacture

 

Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals, and birds that cause respiratory, enteric, hepatic, and neurologic diseases. Four viruses - 229E, OC43, NL63, and HKU1 are prevalent and typically cause common cold symptoms in immunocompromised individuals. Three other strains SARS-CoV, MERS-CoV, and SARS-CoV-2 (COVID-19) can be transmitted from between non-human vertebrates to humans.

 

The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general, antibodies can be detected 1-3 weeks after infection. This test is intended to screen patients for SARS-CoV-2 antibodies.

 

This test has been authorized by the FDA under an 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. 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 Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.

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 product is intended for professional use and not for home use. Not for the screening of donated blood.

Instructions For Use

1. Remove the test cassette from the sealed foil pouch and use it as soon as possible.


2. Lay the device on a flat surface and add specimen (see specific instructions for each specimen type below):


a. For Serum or Plasma Specimen: With the plastic dropper provided, draw serum/plasma specimen to exceed the specimen line, as shown in the diagram below. Hold the dropper vertically and transfer the drawn serum/plasma specimen into the sample well (S). Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well (B) ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.

b. For Whole Blood Specimen: Hold the plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the sample well (S) of the test device. Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well (B) ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.


3. Wait for the control line (C) to change from blue to a red color. If, after 2 minutes, the sample has not moved across the test window or if blood is still present in the sample well (S), add 1 additional drop of sample buffer to the buffer well (B).
 

4. The results should be read in 10 minutes. Do not interpret the result after 15 minutes.

 

Frequently asked questions

What is COVID-19?


COVID-19 is caused by the SARS-CoV-2 virus. The virus can cause mild to severe respiratory illness and has spread globally, including the United States. The current information available to characterize the spectrum of clinical illness associated with COVID-19 suggests that symptoms include cough, shortness of breath or difficulty breathing, fever, chills, muscle pain, headache, sore throat or new loss of taste or smell.




How are people tested for COVID-19?


Two kinds of tests are currently available for COVID19: diagnostic tests and antibody tests.

  • A diagnostic test tells you if you have a current infection.
  • An antibody test tells you if you had a previous infection.




What is the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) test?


This test is an antibody test. It will help assess if you have antibodies to the virus that causes COVID-19. An antibody test may not be able to show if you have a current infection, because it can take 1-3 weeks after infection to make antibodies.




What is the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) test?


This test is an antibody test. It will help assess if you have antibodies to the virus that causes COVID-19. An antibody test may not be able to show if you have a current infection, because it can take 1-3 weeks after infection to make antibodies.




What are the known and potential risks and benefits of the test?


Potential risks include:

  • Possible discomfort or other complications that can happen during sample collection.
  • Possible incorrect test result (see below for more information).
Potential benefits include:
  • The results, along with other information, can help you and your healthcare provider make informed recommendations about your care.




What does it mean if I have a positive test result?


If you have a positive test result, it is possible that you have had recent or prior COVID-19 infection and that you have developed an antibody response to the virus. Your healthcare provider will work with you to determine how best to care for you based on the test results along with other factors of your medical history, your symptoms, possible exposures, and geographic location of places you have recently traveled. There is also the small possibility that this test can give a positive result that is wrong (a false positive result). Even a high-performing antibody test when used in a population without many cases of COVID-19 infection may produce as many or more false results as true results because the likelihood of finding someone who has been infected is very small. Your healthcare provider will work with you to determine the likelihood of false result. It is not known how long antibodies to SARS-CoV-2 will remain present in the body after infection. It is not known whether having antibodies to SARS-CoV-2 will protect you from getting infected again or help reduce the severity or duration of a future COVID-19 infection.




What does it mean if I have a negative test result?


A negative test result means that the antibodies to the virus that causes COVID-19 were not found in your sample. However, it is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID-19. A negative result may occur if you are tested early in your illness and your body hasn’t had time to produce antibodies to infection. This means that you could possibly still have COVID-19 even though the test is negative. If this is the case, your healthcare provider will consider the test result together with all other aspects of your medical history (such as symptoms, possible exposures, and geographical location of places you have recently traveled) in deciding how to care for you.
It is important that you work with your healthcare provider to help you understand the next steps you should take.




Is this test authorized by the FDA


The FDA can make tests available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA for this test 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 for the detection and/or diagnosis of the virus that causes COVID-19. This EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration justifying emergency of IVDs, unless it is terminated or revoked by FDA (after which the test may no longer be used).




Where can I go for updates and more information?


There are no approved available alternative tests. FDA has issued EUAs for other antibody tests that can be found at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#2019-ncov.





Need more details? Contact us

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Need more details? Contact us

We are here to assist. Contact us by phone, email or via our social media channels.

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Norcross, GA 30092

Tel: 470-300-1191

Fax: 470-300-1192

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