Analyse-it urges caution on the widespread use of COVID-19 IgM/IgG rapid tests

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There is a need for caution when applying tests to a population where there may be a low prevalence of illness. Tests must be properly validated and understood so they can be used appropriately in decision making.

Many potential users of these tests are people with no statistical or clinical background, and there is a real need for them to understand the usefulness of a test in the real-world.

Analyse-it Software, Ltd., 2nd April 2020, released a paper on understanding the usefulness of COVID-19 IgM/IgG antibody rapid tests when applied to a population.

With the surge in finger prick lateral flow COVID-19 IgM/IgG antibody tests, manufacturers need to ensure they establish rigorous performance claims for their test kits. As Professor Whitty, the UK chief medical officer, warned, the 'one thing worse than no test is a bad test.' Some of the kits we reviewed made few or sketchy performance claims. The performance claims of others that are proposed to be used on millions of people are based on less than 100 subjects. The Analyse-it Method Validation software offers the statistical analysis needed to establish and validate such performance claims.

It is also vital that suppliers of tests play their part in ensuring that the tests are used in appropriate scenarios. As Simon Huntington, Director of Statistical Products at Analyse-it, emphasizes, "Many potential users of these tests are people with no statistical or clinical background, and there is a real need for them to understand the usefulness of a test in the real-world. Today, we released a paper that urges the need for caution when applying tests to a population where there may be a low prevalence of illness. Tests must be properly validated and used appropriately in decision making."

To download our paper visit: https://analyse-it.com/company/media/COVID-19/Whitepaper.pdf

About us
Analyse-it Software, Ltd. is the leading developer of statistical analysis software for diagnostic test method validation. First released in 1997, Analyse-it is used by the world's leading in-vitro diagnostic companies and government regulatory agencies and is cited in thousands of published peer-reviewed articles in respected journals.
https://analyse-it.com

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Simon Huntington
Analyse-it Software, Ltd.
media@analyse-it.com

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Simon Huntington