COVID-19 IgM/IgG Rapid Test

BioMedomics has developed and launched one of the world’s first rapid point-of-care lateral flow immunoassays for the diagnosis of coronavirus infection. The test has been used widely by the Chinese CDC to combat infections and is now available globally. This test detects both early marker and late marker, IgM/IgG antibodies in human finger-prick (capillary) or venous whole blood, serum, and plasma samples. 

It can be used for rapid screening of carriers of the virus that are symptomatic or asymptomatic. Recent studies suggest that a high percentage of patients show no clinical symptoms of the virus, thus screening patients is vitally important. The test is ideally suited for hospitals, clinics and test laboratories. The test can also be effectively deployed in businesses, schools, airports, seaports and train stations, etc., giving it the potential to become a compelling force in the fight against this global threat. 

NOTE: Updated USFDA 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. Please see FAQ’s below for more detailed information.

This product has CE-IVD registration. You can download the Certificate of Conformity here.

Features & Benefits

BioMedomics Rapid IgM-IgG Combined Antibody Test for COVID-19 is used to qualitatively detect IgG and IgM antibodies of the novel coronavirus in human serum, plasma or whole blood in vitro.

Precise

  • Works with whole blood, serum, & plasma
  • Tests for both IgM and IgG antibodies
  •  Validated using PCR

Fast

  • 10-15 minutes per test
  • Intuitive visual interpretation
  • No special equipment needed

How It Works

COVID-19_4 steps_NEW_Web

Steps

1. Collect blood/serum/plasma sample.

2. Add blood/serum/plasma sample to sample well.

3. Place 2-3 drops of buffer in sample well.

4. Read results after 10 minutes and no more than 15 minutes.

Results

FAQs

On March 16, 2020 the FDA updated its Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. The updates include guidance for commercial manufacturers such as BioMedomics for serology test that identify antibodies (e.g., IgM, IgG) to sARS-CoV-2 from clinical specimens. The policy allows testing in laboratories or by healthcare workers at the point-of-care. The policy does not apply to at-home testing.

While our FDA EUA application is under review, please note the following information:

  • This test has not been reviewed by FDA
  • 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.
  • 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.
  • 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. 

BioMedomics Rapid IgM-IgG Combined Antibody Test for COVID-19 is a lateral flow immunoassay used to qualitatively detect IgG and IgM antibodies of the novel coronavirus in human serum, plasma or whole blood in vitro. 

This test should not be used with heat inactivated or other inactivated human specimen (blood, serum, plasma). Fresh samples should be collected and tested immediately.

The test strip contains a colloidal gold-labeled recombinant novel coronavirus antigen and quality control antibody colloidal gold marker, two detection lines (G and M lines) and one quality control line (C) fixed on a nitrocellulose membrane. M is fixed with monoclonal anti-human IgM antibody for detecting the novel coronavirus IgM antibody. G is fixed with monoclonal antihuman IgG antibody for detecting the novel coronavirus IgG antibody. The quality control antibody is fixed on the C line.

Results are valid 10 minutes after sample and buffer are combined in the cassette sample well. 

In order to test the detection sensitivity and specificity of  the COVID-19 IgG-IgM combined antibody test, blood samples were collected from COVID-19 patients from multiple hospitals and Chinese CDC laboratories. The tests were done separately at each site. A total of 525 cases were tested: 397 (positive) clinically confirmed (including PCR test) SARS-CoV-2-infected patients and 128 non- SARS-CoV-2-infected patients (128 negative). The testing results of vein blood without viral inactivation were summarized in the Table 1. Of the 397 blood sample from SARS-CoV-2-infected patients, 352 tested positive, resulting in a sensitivity of 88.66%. Twelve of the blood samples from the 128 non-SARS-CoV-2 infection patients tested positive, generating a specificity of 90.63%.

A total of three detection lines are possible, with the control (C) line appearing when sample has been flowed through the cassette.
1 | Negative Result: If only the quality control line (C) appears and the detection lines G and M are not visible, then no novel coronavirus antibody has been detected and the result is negative.
2 | Positive Result, M only: If both the quality control line (C) and the detection line M appears, then the novel coronavirus IgM antibody has been detected and the result is positive for the IgM antibody.
3 | Positive Result, G only: If both the quality control line (C) and the detection line G appears, then the novel coronavirus IgG antibody has been detected and the result is positive for the IgG antibody.
4 | Positive Result, G and M: If the quality control line (C) and both detection lines G and M appear, then the novel coronavirus IgG and IgM antibodies have been detected and the result is positive for both the IgG and IgM antibodies.

The COVID-19 IgM/IgG Rapid Test can be used to screen patients suspected of having been affected by the novel coronavirus. However, results of  test should not be the only basis for diagnosis. Results should be used in combination with clinical observations and other testing methods such as nucleic acid PCR test.

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Contact Info

ADDRESS

BioMedomics, Inc. 1100 Perimeter Park Drive Suite 104 Morrisville, NC 27560 USA

CALL US

919.890.3070

E-MAIL

info@biomedomics.com