COVID-19 IgG/IgM Point of Care Rapid Test

The COVID-19 IgG/IgM Rapid Test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 novel coronavirus in human whole blood, serum or plasma.  The company’s licensed COVID-19 IgG/IgM Rapid Test is approved for distribution throughout the U.S. based upon the FDA’s Emergency Use Authorization (EUA) policy.  The COVID-19 IgG/IgM Rapid Test is intended for professional use only and delivers clinical results between 2 and 10 minutes at the point-of-care by analyzing samples from individuals having signs and symptoms of SARS-CoV-2 infection.  This test has been validated in a 126 patient clinical trial and is CE marked.

DISCLAIMER: Aytu BioScience has notified the FDA that we have validated and will begin offering the COVID-19 IgG/IgM Rapid Test. 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 updated policy can be viewed by clicking here. The FDA has not reviewed Aytu BioScience’s validation of the test.

COVID-19 IgG/IgM Package Image

TEST OVERVIEW

  • Utilizes human whole blood, serum, or plasma
  • Used in rapid, qualitative and differential detection of IgG and IgM antibodies
  • Delivers clinical results between 2 and 10 minutes at the point-of-care
  • Visual interpretation of results
  • No special equipment needed

PERFORMANCE CHARACTERISTICS

The COVID-19 lgG/lgM Rapid Test (Whole Blood/Serum/Plasma) has been evaluated with the 126 samples obtained from patients exhibiting pneumonia or respiratory symptoms.  The results were compared to Fluorescent Real Time Polymerase Chain Reaction (RT-PCR) or clinical diagnosis (including chest Computed Tomography and clinical signs etc.) of “Diagnosis and treatment of novel coronavirus pneumonia”.

IgG/IgM Rapid Test results compared to SARS-CoV-2 RT-PCR results:

COVID-19 RT-PCR Assay COVID-19 IgG/IgM Test
Positive Negative Total
Positive 103 9 112
Negative 0 14 14
Total 103 23 126
95% CI
Sensitivity 103/112 91.9% (85.3% – 96.3%)
Specificity 14/14 100% (76.8% – 100%)
Overall 117/126 92.8% (86.9% – 96.7%)

The sensitivity of lgM only test is 89.2% (100/112) and specificity is 100% (14/14).
The sensitivity of lgG & IgM test is 91.9% (103/112) and specificity is 100% (14/14).

RT-PCR Method testing was included as clinical site method. Nucleic acid was detected by probe fluorescence PCR. This product contained primers and probes (ORF1ab gene and N gene strains of coronavirus) and internal controls (housekeeping gene beta Globin gene sequences) used in RT-PCR for the in vitro qualitative detection of SARS-CoV-2  RNA in nasopharyngeal swab specimens. The novel coronavirus2019-ncov specific probe was respectively labeled with FAM fluorescence and ROX fluorescence, and the internal standard gene was labeled with VIC fluorescence. The minimum detection limit of the fluorescent RT-PCR assay is 10 copies/reaction.

LIMITATIONS

  1. Use fresh samples only.
  2. This test has not been reviewed by the FDA.
  3. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus.
  4. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
  5. 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.
  6. 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. Some specimens containing unusually high titer of heterophile antibodies or rheumatoid factor may affect expected results.
  7. Not for the screening of donated blood

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 COVID-19 IgG/IgM Rapid Test are asked to send email inquiries to COVID-19@aytubio.com

What is coronavirus and how is it spread?

The term coronavirus refers to a family of viruses, some causing illness in people and others that circulate among animals. The SARS-CoV-2 strain was first identified in Wuhan, China in December 2019. Public health officials have identified the source of this virus in bats and are investigating its spread from animal to human and human to human. It is typically spread by respiratory droplets from coughs or sneezes, similar to the way flu and other respiratory viruses spread.

What is the incubation period for COVID-19?

Infectious disease experts have determined that symptoms can begin within 14 days of initial exposure to the virus.

What are the primary symptoms?

Primary symptoms are:

  • Cough
  • Fever
  • Shortness of breath

If you have recently traveled to China or other parts of the world where outbreak is prevalent, or been in close contact with someone who traveled to those countries and have any of the above symptoms, contact your healthcare provider right away.

What’s the best way to seek care?

Remember: this is a highly contagious virus, so it is not recommended that you enter a health care facility potentially exposing many other individuals. If you feel you have been exposed – call your doctor or 911 and let them know about your symptoms and recent travel history.

How is COVID-19 diagnosed?

A special laboratory test performed by the CDC or some state’s Department of Health can confirm diagnosis. A diagnosis may be inconclusive with only a physical exam because mild cases of the new coronavirus may appear similar to the flu or bad cold.

How is COVID-19 treated?

Currently, there is no targeted treatment or vaccine. Standard supportive measures for any respiratory illness will be used.

What can I do to prevent COVID-19?

Take the following easy to follow precautions:

  • Wash your hands frequently with soap and water
  • Avoid close contact with people who are sick
  • Cover your mouth and nose when coughing/sneezing
  • Refrain from touching your eyes, nose or mouth with unwashed hands
  • Stay home from work or school if you feel unwell
  • Vaccines have the potential to prevent or treat a wide range of infectious diseases. Make sure that everyone in your house (including yourself) has received the flu shot to stay healthy and safe
  • The benefit of wearing facemasks is not proven and they are not recommended as a preventive measure.

For additional information and updates on COVID-19, visit these sites: