COVID-19 IgM/IgG Rapid Test
BioMedomics has developed and launched one of the world’s first rapid point-of-care lateral flow immunoassays to aid in the diagnosis of coronavirus infection. The test detects both early marker and late marker, IgM/IgG antibodies in human finger-prick (capillary) or venous whole blood, serum, and plasma samples.
There is a critical, global need for serology assays that can complement nucleic acid (PCR) tests for diagnosing COVID-19 infection. Although critically important, PCR tests are only positive during the brief window of acute infection, after which they become negative. And while serology tests are not as effective as PCR early in acute infection, they are able to detect COVID-19 antibodies for a prolonged period of time after disease resolution, which enables identification of prior infection. Knowledge of prior infection is epidemiologically important and represents a significant unmet need in the management of the COVID-19 pandemic.
NOTE: Updated USFDA guidance issued on May 4, 2020, allows the distribution of this product for use in laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratory’s CLIA certificate for high-complexity testing. The updated policy can be viewed by clicking here. Please see FAQ’s below for more detailed information.
This product has CE-IVD registration.
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.
- Works with whole blood, serum, & plasma
- Tests for both IgM and IgG antibodies
- Validated using PCR
- 10-15 minutes per test
- Intuitive visual interpretation
- No special equipment needed
How It Works
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.
On May 4, 2020 the FDA updated its Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. The document includes 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 certified to perform high complexity testing, and at the point-of-care when covered by the laboratory’s CLIA certificate for high-complexity testing. The policy does not apply to at-home testing.
Laboratories and healthcare providers must include this information in their patient test report as specified in FDA guidance:
- This test has not been reviewed by FDA
- Negative results do not rule out SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
- Results from antibody testing should not be used to diagnose or exclude SARS-CoV-2.
- 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.
The BioMedomics COVID-19 IgM-IgG Rapid Test was tested under the validation program on April 21, 2020 at the Frederick National Laboratory for Cancer Research (FNLCR) located in the USA, a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI). The COVID-19 IgM-IgG Rapid Test is intended to test IgM and IgG separately. The test was validated against a panel of previously frozen samples consisting of thirty (30) SARS-CoV-2 antibody-positive serum samples and seventy (70) antibody-negative serum and plasma samples. Each of the 30 antibody-positive samples were confirmed with a nucleic acid amplification test (NAAT) and both IgM and IgG antibodies were confirmed to be present in all 30 samples. The presence of antibodies in the samples was confirmed by several orthogonal methods prior to testing with the BioMedomics, Inc. COVID-19 IgM-IgG Rapid Test. The presence of IgM and IgG antibodies specifically was confirmed by one or more comparator methods. Antibody-positive samples were selected at different antibody titers. All antibody negative samples were collected prior to 2020 and include 70 samples selected without regard to clinical status (“Negatives”). Testing was performed by one operator using one lot of the BioMedomics COVID-19 IgM-IgG Rapid Test. Confidence intervals for sensitivity and specificity were calculated per a score method described in CLSI EP12-A2 (2008).
The BioMedomics COVID-19 IgM-IgG Rapid Test displayed a combined sensitivity of 96.7% and a combined specificity of 97.1%.
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.