COVID-19 IgG/IgM Rapid Test

The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood, plasma from anticoagulated blood (Li+ heparin, K2EDTA and sodium citrate), or serum.  The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, to perform moderate or high complexity tests.

The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is only for use under the Food and Drug Administration’s Emergency Use Authorization.

COVID-19 Rapid Test Product Package

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
  • Visual interpretation of results
  • No special equipment needed

PERFORMANCE CHARACTERISTICS

The clinical performance of the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) was evaluated by testing a total of 191 plasma (K2EDTA) clinical samples—90 positive samples and 101 negative samples) from individual patients exhibiting pneumonia, respiratory symptoms and fever etc. Testing was performed at two sites in China from January to mid-March 2020. COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) results for IgM and IgG detection were compared to the results of RT-PCR assays for SARS-CoV-2 from oropharyngeal swabs (Site #1) and sputum (Site #2).

Method

RT-PCR

Subtotal

Positive

Negative

COVID-19 IgG/IgM Rapid Test Cassette

Positive

IgG+ / IgM+

78

0

78

IgG+ / IgM+

0

1

1

IgG+ / IgM+

9

2

11

Negative

IgG+ / IgM+

3

98

101

Subtotal

90

101

191

IgG
Positive Percent Agreement (PPA): 96.7% (87/90) (95%CI: 90.7% – 98.9%)
Negative Percent Agreement (NPA): 98.0% (99/101) (95%CI: 93.1% – 99.5%)

IgM
Positive Percent Agreement (PPA): 86.7% (78/90) (95%CI: 78.1% – 92.2%)
Negative Percent Agreement (NPA): 99.0% (100/101) (95%CI: 94.6% – 99.8%)

Overall (either IgG+ or IgM+)
Positive Percent Agreement (PPA): 96.7% (87/90) (95%CI: 90.7% – 98.9%)
Negative Percent Agreement (NPA): 97.0% (98/101) (95%CI: 91.6% – 99.0%)

Warning

This test has not been FDA cleared or approved.

This test has been authorized by 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 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.

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 is the best way to seek care?

Remember, this is a highly contagious virus. It is not recommended that you enter a healthcare facility, potentially exposing many other individuals. If you feel you have been exposed, call your doctor or call 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 a 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 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: