Helge for detecting haemolysis

The technology described in this briefing is Helge. It is a point-of-care test to detect haemolysis in blood samples.

The innovative aspects are that it detects haemolysis in whole blood at the point of care when the samples are collected. This provides quality assurance of the samples and helps clinicians' decision making for patient care.

The intended place in therapy would be as an additional intervention to current standard care for detecting haemolysis in blood samples.

The main points from the evidence summarised in this briefing are from 2 cross-sectional studies. Of these, 1 included 1,270 blood samples and the other study included 1,671 people presenting to the emergency department. They show that Helge could detect haemolysis in blood samples, reporting a sensitivity of 80% and a specificity of 99% compared with the laboratory test. Of samples collected by different methods, the haemolysis incidence was 21.3% using a peripheral venous catheter, 2.4% using a butterfly needle and 1.6% using a straight needle. Risk of haemolysis assessed by nurses during blood sample collection was correlated to ease of blood sample collection (observed blood flow).

Key uncertainties around the evidence are that there is no gold standard point-of-care reference test or cut-off threshold to detect haemolysis and compare with the Helge system. There are only 2 studies on the technology and neither of these are from the UK. This means evidence is limited and may not be generalisable to the NHS.

The cost of the Helge system is based on a subscription model. This includes all costs for training, disposables, and the readers (updates and maintenance). Depending on the number of readers and projected use, the price is between £500 and £1,000 per reader per month (excluding VAT). The costs of routine testing in the laboratory are £3.71 (phlebotomy test) and £1.10 (biochemistry test). There are no specific costs for haemolysis.