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.

 

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

CLINICAL PERFORMANCE

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”.

Regarding the IgG/ IgM test, the test result comparison to RT-PCR.

COVID-19 RT-PCR Assay

COVID-19 IgG/ IgM Test

Positive

Negative

Total

Positive

103

0

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.

Warning

This test has not been FDA cleared or approved.

This test detects the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.

This test is only allowed 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 2-14 days of initial exposure to the virus.

What are the primary symptoms?

Primary symptoms are:

  • Cough
  • Fever
  • Shortness of breath

Look for emergency warning signs for COVID-19. If someone is showing any of these signs, seek emergency medical care immediately:

  • Trouble breathing
  • Persistent pain or pressure in the chest
  • New confusion
  • Inability to wake or stay awake
  • Bluish lips or face

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.

How is COVID-19 diagnosed?

SARS-CoV-2 antibody tests are intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, by detecting antibodies to SARS-CoV-2 in human blood specimen.

How is COVID-19 treated?

  • There is currently no vaccine to prevent coronavirus disease 2019 (COVID-19).
  • The best way to prevent illness is to avoid being exposed to this virus.

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
  • Maintain 6 feet of distance between yourself and people who don’t live in your household.
  • 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
  • Monitor your daily health
  • 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.
  • Wear a mask in public settings and when around people who don’t live in your household, especially when other social distancing measures are difficult to maintain.

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