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In vitro diagnostic tests need to be better regulated, say statisticians

BMJ 2024; 385 doi: (Published 30 May 2024) Cite this as: BMJ 2024;385:q1184
  1. Jacqui Wise
  1. Kent

Statisticians have called for better regulation of in vitro diagnostic (IVD) tests—which typically test samples of fluids such as blood, urine, or saliva—to ensure that they are statistically sound and fit for purpose.

A report from the Royal Statistical Society1 was prompted by concerns about lateral flow tests during the covid pandemic, although the recommendations cover all new diagnostic tests.

The report comes just as the Medicines and Healthcare Products Regulatory Agency (MHRA) has ordered a snap consultation2 as part of a drive to improve the safety of some high risk diagnostic tests, including the newly popular over-the-counter self-tests for HIV, glucose levels, hepatitis, and screening tests for a range of cancers. …

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