A novel way to diagnose acute pancreatitis on the spot

Actim® Pancreatitis is a unique point-of-care test to reliably screen acute pancreatitis when speed is vital.

Acute pancreatitis is a common inflammatory condition associated with high morbidity, mortality, and hospitalization costs. Early treatment is critical when acute pancreatitis occurs, but the nonspecific symptoms make diagnosis challenging.

Based on trypsinogen-2, the most accurate biomarker available, Actim Pancreatitis is the only test that can identify acute pancreatitis at any phase of inflammation. As a result, severe pancreatitis is diagnosed early, patients can be treated efficiently, and unnecessary treatment, CT-scans, and costs are avoided.

Actim<sup>®</sup> Pancreatitis
Key facts
  • Reliably rules out acute pancreatitis from simple urine sample
  • Can be used at any stage of the disease
  • More sensitive and specific than amylase and lipase tests
  • Easy-to-use one-step dipstick test
  • Gives test results at the bedside in just 5 minutes
  • No laboratory resources or sample processing is needed
  • The test kit contains all necessary materials and can be stored at room temperature
  • Available in multiple package sizes

How Actim Pancreatitis works

Actim® Pancreatitis rapid test is based on highly specific monoclonal antibodies that detect the pancreatic enzyme trypsinogen-2 in urine. Trypsinogen-2 is the optimal biomarker for acute pancreatitis. It is present throughout pancreatic inflammation – from the beginning until days after the symptoms have started.

As Actim Pancreatitis detects trypsinogen-2 concentrations as low as 50 μg/l and up to 100,000 μg/l, it can reliably detect both advanced symptomatic acute pancreatitis as well as early asymptomatic pancreatitis.

With even 100% sensitivity, Actim Pancreatitis identifies the risk of acute pancreatitis also in patients who would likely be missed if using amylase or lipase tests.

Because of its extremely high (99%) negative predictive value (NPV), Actim Pancreatitis can reliably rule out pancreatitis even in asymptomatic patients. For this reason, negative test results do not have to be verified with CT scans or other tests.

ABOUT TRYPSINOGEN-2

  • Produced by pancreatic acinar cells
  • Secreted into pancreatic juice as a proenzyme, trypsinogen
  • Urinary trypsinogen-2 levels are strongly elevated in acute pancreatitis, and remain elevated for days, or even weeks

TABLE 1. Actim Pancreatitis surpasses both lipase and amylase testing in detecting and ruling our pancreatitis with 100% sensitivity.

Sensitivity % Specificity %
Actim Pancreatitis test 100 96
Lipase 3N 53 99
Amylase 3N 41 95

 

 

TABLE 2. Actim Pancreatitis is a highly sensitive and specific screening tool for acute pancreatitis. With a high NPV, Actim pancreatitis is able to confidently determine patients that are not experiencing pancreatitis, also among those at risk of post-ERCP acute pancreatitis.

 Reference Subjects AP Sensitivity % Specificity % PPV % NPV %
Kemppainen et al., 1997 500 53 94 95 68 99
Kylänpää-Bäck et al., 2000 525 45 96 92 54 99,6
Kylänpää-Bäck et al., 2002 237 29 93 92 63 99
Chen et al., 2005 165 67 90 86 81 92
Jang et al., 2007 191 19 100 96
Post-ERCP-patients
Kemppainen et al., 1997
(quantitative test, 6h post operation)
106 11 81 97
Sankaralingam et al., 20017
(dipstick test, 1h post operation)
29 5 100 91 66 100
Sankaralingam et al., 20017
(dipstick test, 4h post operation)
29 5 100 96 80 100

How Actim Pancreatitis helps

There is currently no golden standard for diagnosing acute pancreatitis. Actim® Pancreatitis is superior to other available options, because it is

  • based on trypsinogen-2, which, unlike amylase, is specific to the pancreas and stays elevated for even weeks
  • more sensitive than lipase-based tests
  • easy to perform, low cost, and radiation-free, as opposed to CT scans

Actim Pancreatitis is the first and only dipstick test that enables diagnosis of acute pancreatitis on the spot – without the need for sample processing or laboratory equipment. Rapid and reliable bedside diagnosis allows timely treatment and reduces diagnostic costs.

With Actim Pancreatitis, pancreatic inflammation resulting from endoscopic retrograde cholangiopancreatography (ERCP) can also be reliably excluded, allowing low-risk patients to be discharged soon after the procedure.

Actim Pancreatitis saves lives, time, and money

  • Quick and reliable screening
  • Medical attention can be directed to patients who need it
  • Unnecessary expensive CT scans can be avoided
  • No need for laboratory facilities
  • Reduces avoidable hospital visits and patient transfers

How to use Actim Pancreatitis

Actim® Pancreatitis test kit contains all necessary materials and can be stored at room temperature: 2–25 °C

  •  Sample collection

Collect urine sample, min. 500 μl

  • Activate the test

Place the yellow dip area into the sample and hold it there until you see the liquid front enter the result area.

Remove the dipstick from the sample and place it horizontal.

  • Interpret results

A positive result can be read as soon as it becomes visible. Two blue lines = symptoms may be due to acute pancreatitis and more investigation is needed.

A negative result should be confirmed at 5 minutes. One blue line = symptoms are not due to acute pancreatitis.

How to order Actim Pancreatitis

Actim® Pancreatitis test kits are available in multiple package sizes. All test kits contain:

  • Dipsticks (individually packed)
  • Instructions for use

Ordering information

  • Actim Pancreatitis 20 test kit, ref: 32732ETAC
  • Actim Pancreatitis 10 test kit, ref: 32731ETAC
  • Actim Pancreatitis Controls, ref: 32700ETAC

Actim® Pancreatitis Controls are intended to be used with the Actim Pancreatitis test for external quality control. The controls may also be used to demonstrate negative results and weak and strong positive results. The control set includes negative, low positive, and high positive controls as well as reconstitution solution.

How to get Actim Pancreatitis

Actim rapid tests are used by medical professionals worldwide. To ensure a prompt delivery, Actim tests are distributed via local companies.

Distributors  Send a question

Disclaimer: Product availability and/or labeling may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability.