COVID-19 IgM/IgG Antibody Rapid Test Kit

COVID-19 IgM/IgG Rapid Test Kit – FDA EUA Authorized

In response to the Coronavirus (COVID-19) pandemic, Eriacta pharmacy is now offering the IgM/IgG antibody rapid test kit to equip healthcare workers for rapid COVID-19 antibody detection. This COVID-19 Rapid Test Kit is suitable for the qualitative detection of SARS-CoV-2 IgM/IgG antibodies in human serum, plasma, or whole blood. Common signs of infection with SARS-CoV-2 include respiratory symptoms, fever, cough, shortness of breath, and dyspnea. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and even death. SARS-CoV-2 can be excreted through respiratory secretions or transmitted through oral fluids, sneezing, physical contact, and through air droplets. Eriacta pharmacy is now offering COVID-19 antigen rapid test kit at wholesale prices for the general public to tested for covid-19 .

IgM/IgG Antibody Rapid Test Kit - HG
NOW AVAILABLE: COVID-19 Antigen Rapid Test Kit Qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 virus in nasopharyngeal (NP) swab specimens. COVID-19 IgM/IgG Rapid Test Kit

Each Box Contains:

25x Individual sealed pouches (1x Test cassette, 1x Desiccant pouch), 25x disposable pipettes, sample diluent and instructions for use (IFU).

100 boxes/Carton, Min Order 50 Cartons 

Specification:

  • IgG sensitivity: 96.7%, specificity: 98.0%. IgM sensitivity: 86.7%, specificity: 99.0%.
  • Overall positive agreement rate of 96.7%, negative agreement rate of 97.0%.
  • Sample Type: whole blood sample, serum and plasma
  • Detection Method: Colloidal Gold
  • Detection Time: 10 – 15 minutes
  • Not suitable for Point of Care Testing
  • FDA EUA approved; CE Certified
 

Each Box Contains:

20x Test Devices, 20x Disposable Pipettes, 20x Alcohol Prep Pads, 20x Sterile Safety Lancets, sample diluent and instructions for use (IFU).

100 boxes/Carton, Min Order 50 Cartons 

 

Specification:

  • IgG sensitivity: 90.0%, specificity: 100.0%. IgM sensitivity: 100.0%, specificity: 98.8%.
  • Overall positive agreement rate of 80.8%, negative agreement rate of 100.0%.
  • Sample Type: Fingertip blood, whole blood sample, serum and plasma
  • Detection Method: Colloidal Gold
  • Detection Time: 10 – 15 minutes
  • Suitable for Point of Care Testing, CLIA waived
  • FDA EUA approved; CE Certified
 

How Does COVID-19 IgM IgG Rapid Test Kit Work?

 

The COVID-19 IgM/IgG antibody rapid test is a fast and effective method for screening IgM and IgG antibodies against SARS-CoV-2. This test can also suggest information on the stage of infection.

Both Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies are produced during the primary immune response. As the body’s largest antibody, IgM is the first antibody to appear in response to an initial exposure to antigens. IgM provides the first line of defence during viral infections, followed by the generation of adaptive, high affinity Immunoglobulin G (IgG) responses for long-term immunity and immunological memory. IgG is usually detectable about 7 days after the IgM appears.

Instructions for Use

COVID-19 IgM/IgG Rapid Test Kit Instruction for Use IFU

Interpretation of Test Results

IgG and IgM POSITIVE (left)Both the test lines and the quality control line are colored in the COVID-19 IgM/IgG Antibody Test Cassette.

IgG POSITIVE (middle)Two lines appear on the COVID-19 IgM/IgG Antibody Test Cassette. One coloured line appears in the control line region, and another coloured line appears in the IgG test line region. The result is positive for SARS-CoV-2 specific-IgG antibodies.

IgM POSITIVE (right)Two lines appear on the COVID-19 IgM/IgG Antibody Test Cassette. One coloured line appears in the control line region, and another coloured line appears in the IgM test line region. The result is positive for SARS-CoV-2 specific-IgM antibodies.

 
COVID-19 antibody test cassette positive result
 

NEGATIVE: One coloured line appears in the control region. No apparent coloured line appears in the IgG or IgM test region.

 
COVID-19 antibody test cassette negative result
 

INVALID: Control line fails to appear. Insufficient sample volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the COVID-19 rapid test kit immediately and contact your local distributor.

 
COVID-19 antibody test cassette invalid result
 

Disclaimer: (The picture is for representation only, markings on test cassette may vary.)

Limitation of COVID-19 IgM/IgG Rapid Test

  1. The product is designed only for use with human serum, plasma, or whole blood samples for the qualitative detection of SARS-CoV-2 IgM and IgG antibody.
  2. As in case of all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test but should rather be made after all the clinical findings have been evaluated and should be confirmed by other conventional detection methods, such as molecular diagnostics and CT.
  3. A false negative may occur if the amount of SARS-CoV-2 IgM or IgG antibody is below the detection level of the kit.
  4. If the product gets wet prior to use, or is stored improperly, it may cause incorrect results.
  5. The test is for qualitative detection of SARS-CoV-2 IgM or IgG antibody in human serum, plasma, or blood samples, it does not indicate the quantity of the antibodies present.