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COVID-19 IgM/IgG Rapid Test
Medakit 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 or venous blood 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. This test can be administered by professionals easily. 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.
Medakit can produce more than 800,000 tests a day.
Medakit is approved on the French Health Ministry Covid-19 platform.
For larger quantities, please contact us by email : firstname.lastname@example.org
Features & Benefits
- Works with whole blood, serum, & plasma
- Tests for both IgM and IgG antibodies
- Sensitivity : 98.31%
- Specificity : 99.23%
- 10 minutes per test
- Intuitive visual interpretation
- No special equipment needed
- Easy to administer the test
How it works
4 Simple Steps
1. Collect blood sample.
2. Add the blood sample to sample well.
3. Place 2 drops of buffer in sample well.
4. Read results after 10 minutes
Medakit 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.
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 clinical sensitivity and specificity of the Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold), blood samples were collected from COVID-19 patients from four hospitals.
The tests were done separately in each site. A total of 603 specimens were tested: 211 positive clinically confirmed patients and 392 negative (non-SARS-CoV-2 infected) patients.
For the IgM test, 202 samples were tested positive out of 211 confirmed samples, resulting in an sensitivity of 95.73%. 3 samples were tested positive out of 392 negative samples, generating a specificity of 99.23%.
For the IgG test, 33 confirmed samples were removed because the samplings were conducted too early for the patients to generate IgG antibodies. Thus 3 samples were tested negative out of 178 confirmed samples, resulting in a sensitivity of 98.31%. 2 samples were tested positive out of 392 negative samples, generating a specificity of 99.23%.
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.
*Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
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.
Medakit new rapid test provides accurate COVID-19 infection diagnosis in 10 minutes.
It is widely accepted that IgM provides the first line of defense during viral infections, followed by the generation of adaptive, high affinity IgG responses for long term immunity and immunological memory.
Therefore testing of COVID-19 IgM and IgG antibodies is an effective method for the rapid diagnosis of COVID-19 infection. Furthermore, detection of COVID-19 IgM antibodies tends to indicate a recent exposure to COVID-19, whereas detection of COVID-19 IgG antibodies indicates a later stage of infection. Thus, this combined antibody test could also provide information on the stage of infection.