Advice
The technology
The technology
Actim Pancreatitis (Medix Biochemica) is a point-of-care test to diagnose acute pancreatitis. The test works by detecting levels of trypsinogen‑2 (from approximately 50 micrograms/L up to 100,000 micrograms/L) in urine, based on immunochromatography. Trypsinogen‑2 is a pancreatic enzyme, which is elevated in the urine of patients with acute pancreatitis. The dipstick should be placed in a urine sample (minimum volume of 500 microlitres). Trypsinogen‑2 in the sample will bind to monoclonal antibodies in the test strip. If levels exceed the cut-off value for the test, a positive blue line (test line) will appear in the result area. A second blue line confirms the test has worked properly. A negative test result should be confirmed at 5 minutes. The Actim Pancreatitis test kit contains all necessary materials and can be stored at room temperature (2°C to 25°C).
Innovations
Actim Pancreatitis is a dipstick test which allows relatively rapid assessment of the likelihood of acute pancreatitis in emergency situations, without the need for processing in a laboratory.
Current care pathway
People with acute pancreatitis usually have sudden-onset upper abdominal pain and are referred to emergency medicine. Other symptoms may be present, including feeling or being sick, diarrhoea, indigestion, fever, jaundice, tenderness or swelling of the abdomen and a fast heartbeat. People may also have a history of gallstones or excessive alcohol intake, although it should not be assumed the cause is alcohol-related if the person drinks alcohol. Diagnosis is usually made through physical examination and confirmed using blood tests for lipase or amylase levels, which are usually elevated in acute pancreatitis. If elevated lipase and amylase levels in the blood are not detected, abdominal CT may be done to confirm pancreas inflammation.
NICE's guideline on pancreatitis is relevant to this care pathway.
Population, setting and intended user
Actim Pancreatitis is intended to be used in emergency medicine to help diagnose acute pancreatitis in people with suspected symptoms. The most common presenting symptom of acute pancreatitis is upper abdominal pain which steadily gets worse and may move to the back. The company states that the test can also be used in people who have had endoscopic retrograde cholangiopancreatography (ERCP). ERCP is a test to examine and diagnose conditions of the liver, bile ducts, pancreas or gallbladder. It is associated with a 5% to 10% increase in the risk of pancreatitis (The National Pancreas Foundation, 2019).
Acute pancreatitis is a condition in which the pancreas becomes inflamed over a short period of time. It can develop quickly and can be mild or life threatening. For most people with acute pancreatitis, the condition settles over a few days. In 25% of cases however, it is severe and associated with complications such as respiratory or kidney failure, or the development of abdominal fluid collections. These people often need critical care and a prolonged hospital stay. Overall the mortality rate in acute pancreatitis is approximately 5% but can be up to 25% in severe cases. People who are aged over 70, obese, have 2 or more alcoholic drinks a day, smoke or have a family history of pancreatitis are more likely to develop severe pancreatitis. The incidence of acute pancreatitis in the UK is approximately 56 cases per 100,000 people every year. The condition is commonly caused by gallstones (around 50% of cases) or drinking too much alcohol (25% of cases), but in some cases no cause can be found.
Actim Pancreatitis would be used in secondary care by clinicians or nurses working in emergency medicine. It may also be used by gastroenterologists.
Costs
Technology costs
The cost per test for Actim Pancreatitis is £4.50 (excluding VAT). The company states that this cost includes all necessary materials and consumables and that no other purchases are needed.
Costs of standard care
Average laboratory costs for serum amylase and lipase tests are £1.10 for an inpatient serum amylase or lipase test blood test or £4.81 for an outpatient blood test (includes £1.10 for biochemical test and an additional £3.71 for the phlebotomy costs; NHS reference costs 2018/19).
Resource consequences
The technology could be resource releasing if it leads to a reduced risk of misdiagnosing acute pancreatitis or reduces the delay to diagnosis and treatment. However, this is not supported by the available evidence. The technology is a simple dipstick test with all necessary materials that can be stored at room temperature. Adopting the technology will not need any changes to facilities or infrastructure, and little to no staff training will be needed to use the test.