Bringing new and effective diagnostic technologies to the NHS

Identifying whether a patient with certain symptoms has a particular disease can be critical in ensuring their health outcome. A prompt and accurate diagnosis can both rule out whether a person has a specific disease, and assess how advanced or severe the disease is.

As part of our work on evaluating medical technologies, our Diagnostics Assessment Programme focuses on evaluating medical diagnostic technologies. The programme aims to ensure the NHS is able to adopt clinically and cost effective diagnostic technologies both rapidly and consistently.

The diagnostics assessed cover a range of measurements and tests used to evaluate a patient’s condition. These include:

  • physiological measurements
  • laboratory tests and pathology tests
  • imaging tests
  • endoscopy

The Medical Technologies Advisory Committee (MTAC) selects diagnostic technologies for evaluation by the Diagnostics Assessment Programme (DAP). The DAP provides specialist capacity for undertaking complex assessments of diagnostic technologies applying detailed knowledge of the post diagnosis care pathways. Diagnostic technologies evaluated by the DAP are assessed using a cost-effectiveness approach.

This year we have produced guidance on five new diagnostic tests.

NICE says yes to faster tests for heart attacks

In September 2014, we produced guidance which approved two tests for heart attacks that could help reduce length of hospital stay and lead to earlier access of treatment.

Around 700,000 people are admitted to emergency departments with acute coronary syndrome each year, usually with symptoms of chest pain.

A method of diagnosing whether a heart attack has occurred is to measure the level of the protein called troponin in the blood. This is because troponin is often released into the blood when the heart is damaged due to a heart attack.

In general, tests for troponin are carried out between 10 to 12 hours apart to detect any change in levels. This often means that patients need to remain in hospital while the tests are being carried out.

The guidance says that two new tests are both effective at measuring troponin levels more quickly. It recommends both the Elecsys troponin T high-sensitive assay and the ARCHITECT STAT high-sensitivity troponin I assay as diagnostic tests for heart attack.

Both tests are of higher sensitivity than conventional troponin tests and so allow for earlier detection of changes in troponin levels.

This could mean earlier rule-out of heart attack in people presenting with chest pain and suspected acute coronary syndrome. It could also lead to shorter hospital stays for patients with raised levels of troponin, and earlier intervention for those in whom a heart attack has been confirmed.

The guidance adds that as with standard cardiac troponin tests, the new tests need to be used alongside clinical history taking and ECG monitoring to diagnose a heart attack known as a non-ST segment elevation myocardial infarction (NSTEMI).

Professor Carole Longson, Director of the Centre for Health Technology Evaluation, said: “Use of these high-sensitivity tests enables the earlier detection of changes in troponin levels.

“This in turn can allow doctors to rule out a diagnosis of a specific type of heart attack called a NSTEMI within as little as 4 hours from the patient being seen in the emergency department.”

“The increased sensitivity of these tests could mean a reduced length of stay for people without raised levels of troponin, and earlier treatment for those with a confirmed NSTEMI,” she added.

A study published later in the year by the BMJ found that the tests could also double the proportion of women diagnosed with heart attack and bring rates in line with those among men.

A device to prevent life-threatening blood loss during surgery

In August 2014, we produced guidance on tests for detecting, managing and monitoring haemostasis.

The guidance recommended two testing devices that could help detect life-threatening bleeding problems in people during and after cardiac surgery.

During surgery coagulopathy can occur, which is when the blood clotting process can be disrupted. This can result in excessive and sometimes life-threatening blood loss.

Coagulopathy can occur in a range of clinical situations, yet it cannot currently be easily detected through laboratory coagulation testing.

Point of care viscoelastometric testing of blood can be used to determine whether the bleeding is a result of coagulopathy or surgical bleed. The testing helps guide the clinician select the most appropriate treatment to stop the bleeding.

Our guidance recommended the ROTEM system and the TEG system to help detect, manage and monitor the blood clotting process during and after cardiac surgery.

The guidance also recommended the Sonoclot system only in research to help detect, manage and monitor blood clotting during and after cardiac surgery.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “Current laboratory testing is only able to identify when blood is not clotting properly, not what part of the clotting process is disrupted. By using these new tests, clinicians will be able to determine what has caused a bleed and tailor treatment to the cause of the coagulopathy rather than replacing blood with transfusion, or undertaking a further operation.

“The evidence shows that not only is the use of these tests associated with fewer deaths, but also a reduced probability of experiencing complications, fewer transfusions and lower hospitalisation costs.”