BioMedomics 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 or venous blood samples. It can also be used to test human serum or plasma samples.

This CE marked test 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.

• Detection of IgM and IgG antibodies to COVID-19 in a single test
• Suitable for whole blood, serum and plasma samples
• Results in 15 minutes
• Validated using PCR
• Visual interpretation
• No special facilities or equipment necessary
• No specialised training required
• Room temperature storage
• CE Marked

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 by eye after 15 minutes.

Results

Negative Result: If only the quality control line (C) appears and G and M are not visible, then the result is negative.

Positive Result, M only: If both C and M appear, then the result is positive for the IgM antibody.

Positive Result, G only: If both C and G appear, then the result is positive for the IgG antibody.

Positive Result, G and M: If C and both G and M appear, then the result is positive for both the IgG and IgM antibodies

Validation

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 samples 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%.

• Biomedomics brochure

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