Advice
The technology
The technology
Helge (Hemcheck) is used for photometric haemolysis detection. The system analyses free haemoglobin in plasma or serum. It is intended for testing in whole blood at the point of care when a sample is being taken to inform a diagnosis.
The Helge system is designed to find haemolysed blood samples directly at the point of care and provide quality assurance of the samples. Helge has 2 different disposable tests: s-test for blood gas syringes and v-test for test tubes. When blood is collected using a gas syringe or a test tube, a small amount of blood is dispensed into the disposable test. This separates whole blood to plasma or serum. The disposable test with the sample is then placed onto a reader (Helge H10 reader) to see whether the blood sample is haemolysed. The haemoglobin concentration is measured in an interval between 0 g/litre and 10 g/litre and translated to a haemolytic index. The user can define which values of a haemolytic index (between 0 and 555) should be considered positive for haemolysis. The cut off is adjustable using software settings in the system.
Innovations
Helge is a point-of-care technology that can test blood samples for haemolysis without the need for centrifugation. This could avoid potential errors caused by haemolysed blood samples. The company notes that there is currently no point-of-care technology that can detect haemolysis in blood gas analysis. It claims that Helge can provide fast test results that improve patient care.
Current care pathway
Haemolysis happens when red blood cells burst and release the blood cell content into the plasma. Haemolysis may happen inside or outside the body. Haemolysis inside the body is a result of a number of medical conditions, such as genetic disorders or autoimmune disorders. Outside the body, haemolysis is triggered by improper or mishandled procedures during sampling collection and transportation. For example, when collecting a blood sample, squeezing a finger too hard can cause haemolysis. Haemolysis has been recognised as the most common pre-analytical artefact found in laboratory blood samples. Blood is usually re-collected if the blood sample is haemolysed.
There are no NICE guidelines for testing haemolysis. The British Committee for Standards in Haematology is currently producing a guideline on autoimmune haemolytic anaemia.
Population, setting and intended user
Helge is intended to detect haemolysis in whole blood samples. It enables healthcare professionals to test blood for haemolysis at the patient's side. This provides information for clinical decisions at the point of care and also avoids taking unnecessary blood samples.
The system would be used by nurses and phlebotomists in the NHS. It would most likely be used in intensive and emergency care settings.
Costs
Technology costs
The cost of the technology is based on a subscription model that includes all costs for training, disposables, and the readers (updates and maintenance). Depending on the number of readers and projected consumption rate per reader, the price is between £500 and £1,000 per reader per month (excluding VAT).
Costs of standard care
The costs for standard laboratory blood tests are £3.71 for the phlebotomy test and £1.10 for every separate biochemistry test, such as urea and electrolytes tests (reference cost 2018/19). There is no specific cost for haemolysis, but a haemolysed blood sample would have to be repeated.
Resource consequences
The technology has been launched in the UK but has not yet been used in the NHS.
The potential barrier to using the technology in the NHS is the cost. The company indicated that Helge costs more than a standard test for haemolysis in the laboratory. But it could be resource releasing if it leads to improved lead time and reduction in unnecessary blood tests. The estimate of the cost of repeating haemolysed specimens was based on an average of 60 admissions per day. This was £4,355 per month, plus additional time and equipment costs (Jacobs et al. 2012). The costs for additional length of stay for patients with rejected samples (those that could not be processed in the laboratory) were about £7.01 per hour or £168.17 per day, excluding investigative and treatment costs (Bodansky et al. 2017). Using the technology in the NHS would not need any change to facilities or infrastructure. The company noted the technology is easy to use and training is needed to do the tests and interpret the results.