Active B12 assay for diagnosing vitamin B12 deficiency

NICE has developed a medtech innovation briefing (MIB) on the Active‑B12 assay for diagnosing vitamin B12 deficiency.

The Abbott ARCHITECT Active‑B12 assay is a test for detecting levels of serum holotranscobalamin, which is the metabolically available component of vitamin B12, and can be used as a marker of vitamin B12 deficiency. Four diagnostic test accuracy studies, using different reference standards, reported greater diagnostic accuracy for the Active‑B12 assay compared with assays measuring other markers of vitamin B12 deficiency. The assay needs less sample preparation than a total vitamin B12 test and the expected cost is about £3.50 per test including VAT, depending on sample throughput.

Medtech innovation briefings provide a description of the medical technology, including its likely place in therapy, the costs of using the technology and a critical review of the strengths and weaknesses of the relevant published evidence.

Their purpose is to provide objective information on device and diagnostic technologies to aid local decision-making by clinicians, managers and procurement professionals. By making this information available, NICE helps to avoid the need for NHS organisations to produce similar information for local use.

Medtech innovation briefings are not NICE guidance. They differ in format, contain no judgement on the value of the technology and do not constitute a guidance recommendation.

MIBs are commissioned by NHS England and produced in support of the NHS 5 Year Forward View, specifically as one of a number of steps which will accelerate innovation in new treatments and diagnostics.