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Rapid Covid-19 IgM / IgG Point of Care Test

E: A connection is helpful

The IgG/IgM Rapid Test is based on rapid immunochromatographic test. It is used for the detection of 2019 Novel Coronavirus IgG and IgM antibody in human whole blood/serum/plasma, offering a diagnostic reference for COVID 19.

IgG line uses a cocktail of antibodies against Protein N and Protein S.

Have you validated this method, if so, how and what were the results of the validation?​

The method has not been validated in the UK, however A multiple clinical study enrolled 162 positive serum samples from proven COVID 19 patients, and 300 negative samples. Using this kit, 151 cases out of 162 proven samples were positive, with the sensitivity of 93.20%, 286 cases out of 300 clinical excluded samples were negative, with specificity of 95.33%.

How quickly could this be deployed and what are the dependencies?​

The test is manufactured in China and would require thorough validation prior to bulk purchase. Product has been successfully validated and is being used in other territories within Europe and Scandinavia.

What is the likely production volume?​

200,000 to 300,000 tests could be allocated to the UK on a weekly basis.

What are the risks and barriers to using this at scale?​

Independent verification of the test required
Export from China

Who are you already partnering with on this?

AB Molecular Ltd

edited on Apr 20, 2020 by Gareth Williams
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Bev Matthews Apr 21, 2020

The idea has been progressed to the next milestone.

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Bev Matthews Apr 21, 2020

Status label added: E

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Bev Matthews Apr 21, 2020

Thank you Gareth for your submission. The reviewers are currently considering the best place for submissions regarding antibody tests. I will reply again as soon as i have a decision for you.

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Luke Wainwright May 14, 2020

Dear Gareth,

Many thanks for sharing the information above regarding a COVID-19 IgG/IgM Rapid Test kit. As this information does not relate to the testing methods campaign, but is nevertheless of interest to the wider COVID-response, please refer to the 'supply complete testing methods' section on the following webpage:

https://www.gov.uk/guidance/help-the-governme...esting-capacity

Best wishes,
Luke

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Luke Wainwright May 29, 2020

The idea has been progressed to the next milestone.

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