microINR for anticoagulation therapy

The technology described in this briefing is the microINR. It is used for measuring international normalised ratio (INR) levels for people having anticoagulation therapy.

The innovative aspects are that the device offers portable self-monitoring for coagulation with reduced blood sample needs and increased connectivity capabilities.

The intended place in therapy would be as an alternative to hospital‑based testing and alongside alternative point-of-care tests in people who need INR monitoring.

NICE's diagnostics guidance on atrial fibrillation and heart valve disease: self-monitoring coagulation status using point-of-care coagulometers looks at using other INR monitoring devices for anticoagulation therapy.

The main points from the evidence summarised in this briefing are from 5 observational comparative studies including a total of 906 adults across primary and secondary care settings. They show that microINR can be as effective as laboratory-based and alternative point-of-care meters in INR monitoring.

Key uncertainties around the evidence are that 1 study did not meet the accuracy criteria and 1 study did not meet the imprecision criteria. No studies were done in the UK.

The cost of microINR meters range from £299 to £470 per unit (excluding VAT) and microINR chips (disposable test strips) cost between £2.76 and £2.99 per strip; variations seen reflect different distributors. Standard care is alternative point-of-care tests which range from £299 to £590 (excluding VAT) with comparable consumable costs of £2.71 to £3.10 (excluding VAT) per test strip.