BioMedomics COVID-19 IgM/IgG Rapid test

BioMedomics Inc (USA) has developed and launched one of the world’s first rapid point-of-care lateral flow immunoassays for the diagnosis of coronavirus infection. This test detects both 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 as a point of care test for rapid screening to identify individuals who have been previously exposed to the virus. Studies suggest that a significant percentage of patients show no clinical symptoms of the virus, thus screening patients is vitally important in the fight against this global threat.

This kit is registered with the MHRA and sold in the UK

For Professional Use only.

• Detection of IgM and IgG antibodies to COVID-19 in a single test
• Suitable for whole blood, serum and plasma samples
• Results in 10 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 from finger prick (venous blood, serum or plasma may also be used).
2. Add 20µl blood to sample well.
3. Place 2-3 drops of buffer in sample well.
4. Read results by eye after 10 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

Contact us for additional information and availability