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COVID-19 Antibody Test Kit

In vitro qualitative detection of IgM and IgG antibodies in human serum, plasma or whole blood.

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Coronavirus Test Overview

The SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal
Gold) adopts colloidal gold-immunochromatography assay (GICA) for in vitro qualitative detection of IgM and IgG antibodies in human serum, plasma or whole blood from individuals suspected of COVID-19 by their healthcare point of care provider.

This test is currently only provided for use by clinical laboratories or to health care workers for point of care testing, and not for at home testing.

Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. The diagnosis should be confirmed in combination with clinical symptoms or other conventional testing methods.

 

Antibody Test Kit Features:

  • Uses 20uL of human whole blood, serum, or plasma as testing sample
  • Dual differential detection of IgG and IgM antibodies of SARS-CoV-2
  • Results seen in 3 minutes after adding sample to test card at the point-of-care
  • Visual interpretation of results, including an internal control
  • No special additional equipment needed
  • Room temperature storage or refrigeration (4-30⁰C / 39.2-86⁰F)

 

For more information, please contact us at sales@thermogenesis.com or call us at 916.858.5149.

 

DISCLAIMER: ThermoGenesis Corp. has notified the FDA that we will begin offering the SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit. The test is being made available under compliance with Section IV.D. of the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. Updated FDA guidance, issued on March 16, 2020, allows the distribution of this product for diagnostic use in laboratories or by healthcare workers at the point-of-care. The FDA has not reviewed the validation of this test.

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How the COVID-19 Test Kit Works

The ThermoGenesis coronavirus blood test works by rapidly detecting potential COVID-19 antibodies in the blood. The test, which is also known as a serology test, works by using a peripheral blood collector to collect a blood sample from the tip of the finger. Results are visible as little as 3 minutes after sample and diluent are placed in the test card.

Watch the entire COVID-19 Testing process here:

 

The antibody test comes with the following:

  • Sterile Peripheral Blood Collector
  • Disposable Plastic Dropper
  • Sample Diluent
  • Cotton Swabs
  • Desiccant
  • Disposable Test Card

This test can be performed using either human serum, plasma or whole blood samples, including peripheral blood, plasma prepared from clinically used anticoagulants (EDTA, heparin, sodium citrate), etc. Fresh whole blood samples can be collected using components provided with the test and should be tested immediately.


Our Coronavirus Test Procedure

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COVID-19 FAQs

Answering your Coronavirus Testing Questions

1. Is this a combined test?

Yes, the SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit is a combined test that detects both IgM and  IgG antibodies for COVID-19, if either are present in the sample.

 2. Is this an FDA approved COVID-19 Test?

ThermoGenesis Corp. has notified the FDA that we will begin offering the SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit. The test is being made available under compliance with Section IV.D. of the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.

3. What is this COVID-19 testing used for?

The SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit is intended for in vitro qualitative detection of IgM and IgG antibodies in human serum, plasma or whole blood from individuals suspected of COVID-19 by their healthcare provider.

The antibody test is only provided for use by clinical laboratories or to health care workers for point of care testing, and not for at home testing.

However, results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. The diagnosis should be confirmed in combination with clinical symptoms or other conventional testing methods, such as molecular testing.

4. How quickly can this antibody test yield results?

Results are visible as little as 3 minutes after sample and diluent are placed in the test card.

5. Can I purchase this coronavirus antibody test for at-home use?

This antibody test kit is not intended for at home use at this time. The test must be administered by a licensed medical professional. Nonetheless, this is a point of care test, COVID-19 test that does not require sending samples out to a lab for analysis. Therefore, the results can be obtained on-site at a clinic within minutes.

6. How can I place an order coronavirus antibody test kits?

You can request a quote on this page and we will send you a quote. Once you have reviewed the quote, you may submit your purchase order along with the required COVID-19 Request Form and we will process your order.

7. How can I stay informed about the availability of the COVID-19 IgG/IgM test?

Healthcare professionals, institutions, and other interested parties with questions about the Company’s recently licensed SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Test can send email inquiries to Sales.

 

This COVID-19 Rapid Test Kit is suitable for the detection of SARS-CoV-2 IgM/IgG antibodies in human serum, plasma, or whole blood from individuals suspected of possessing or having possessed the novel coronavirus. For more detail on the antibody testing product and safety sheets, see below:

 

  1. SARS-CoV-2 (COVID-19) IgM-IgG Antibody Fast Detection Kit, Safety Data Sheet
  2. SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit Instructions

 

COVID-19 General FAQs


Information taken from the FDA website

1.  What is a novel coronavirus?

A novel coronavirus is a new coronavirus that has not been previously identified. The virus causing coronavirus disease 2019 (COVID-19) is not the same as the coronaviruses that commonly circulate among humans and cause mild illness, like the common cold.

2. What is a coronavirus disease 2019 (COVID-19)?

Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. There are many types of human coronaviruses, including some that commonly cause mild upper-respiratory tract illnesses. COVID-19 is a new disease, caused by a novel (or new) coronavirus that has not previously been seen in humans. Current symptoms reported for patients with COVID-19 have included mild to severe respiratory illness with fever, cough, and difficulty breathing.

3. How can I prevent COVID-19?

The best way to prevent illness is to avoid being exposed to the virus. CDC recommends everyday preventive actions to help prevent the spread of respiratory diseases.

4. What treatments are available for COVID-19?

People with COVID-19 should receive supportive care to help relieve symptoms. People with mild symptoms are able to recover at home. If you experience a medical emergency such as trouble breathing, call 911 and let the operator know you may have COVID-19. For severe illness, treatment should include care to support vital organ functions.

Currently there are no FDA-approved drugs specifically for the treatment of COVID-19. Researchers are studying new drugs, and drugs that are already approved for other health conditions, as possible treatments for COVID-19. The FDA is working with drug manufacturers, researchers, and other partners to accelerate the development process for COVID-19 treatments. CDC has more information for health care providers about these potential treatments. Never take a prescription medicine or drug if it is not prescribed for you by your doctor for your health condition.

 

Additional information and updates on COVID-19:

Centers for Disease Control and Prevention

National Institutes of Health

World Health Organization — International Summary

Food and Drug Administration — Coronavirus Disease 2019 (COVID-19) FAQs

Performance Characteristics of the Antibody Test

The sensitivity, specificity and accuracy of SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit was tested using SARS-CoV-2 virus nucleic acid positive blood samples and negative blood samples, and blank diluent.

 

 

NYBC Evaluation of SARS-CoV-2 (COVID-19) IgM/IgG Antibody Detection Kit

This data was generated as part of a research study conducted at New York Blood Center (NYBC) on convalescent plasma donors. The article “Serological Analysis of New York City COVID 19 Convalescent Plasma Donors” has been submitted for publication and a preprint can be found on medRxiv.

Notes

  1. Ortho-Clinical Diagnostics (Ortho) HTSA results using Total IgG Assay.
  2. Ortho HTSA Total Ig Assay described values >1 as “positive”.
  3. All plasma samples tested were from NYBC convalescent plasma donors enrolled under the following criteria:
    ‣ Diagnosed as COVID-19 infected by PCR testing with documentation.
    ‣ Have waited at least 14 days from the date of last symptom to donate.
  4. ThermoGenesis IgG and IgM Test Results were determined by trained lab technicians to read positive or negative status.

 

Limitations

  1. This product is for qualitative assessment only. This test has not been reviewed by the FDA.
  2. This test is only provided for use by clinical laboratories or to health care workers for point of care testing, and not for at home testing.
  3. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. The diagnosis should be confirmed in combination with clinical symptoms or other conventional testing methods.
  4. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
  5. 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.
  6. Not for screening of donated blood.
  7. It takes a period of time for the antibody to be produced in the human body. It is recommended to retest 5-7 days after the first test.
  8. Within the United States and its territories, all positive results are required to be reported to appropriate public health authorities.

Regulatory Updates

On April 30th, ThermoGenesis submitted a request to FDA for review of validation data in order to obtain Emergency Use Authorization (EUA). FDA has acknowledged receipt of the request and assigned a pre-EUA number, PEUA200895.

On March 31st, ThermoGenesis Corp. notified the FDA that we will begin offering the SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit. The test is being made available under compliance with Section IV.D. of the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. Updated FDA guidance, issued on March 16, 2020, allows the distribution of this product for diagnostic use in laboratories or by healthcare workers at the point-of-care. The FDA has not reviewed the validation of this test.

© 2020 ThermoGenesis Corp.
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