Actim Pancreatitis

Actim® Pancreatitis

Screen for acute pancreatitis on the spot.

Overview

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 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

How it works

Actim Pancreatitis detects trypsinogen-2 – the most accurate analyte for detecting or ruling out acute pancreatitis

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

Sensitivity %Specificity %
Actim Pancreatitis test10096
Lipase 3N5399
Amylase 3N4195
TABLE 1. Actim Pancreatitis surpasses both lipase and amylase testing in detecting and ruling our pancreatitis with 100% sensitivity.

 ReferenceSubjectsAPSensitivity %Specificity %PPV %NPV %
Kemppainen et al., 19975005394956899
Kylänpää-Bäck et al., 20005254596925499,6
Kylänpää-Bäck et al., 20022372993926399
Chen et al., 20051656790868192
Jang et al., 20071911910096
Post-ERCP-patients
Kemppainen et al., 1997
(quantitative test, 6h post operation)
106118197
Sankaralingam et al., 20017
(dipstick test, 1h post operation)
2951009166100
Sankaralingam et al., 20017
(dipstick test, 4h post operation)
295100968010
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.

How it helps

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 it

How to use Actim Pancreatitis

Actim Pancreatitis 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 it

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 | product code 32732ETAC
  • Actim Pancreatitis 10 test kit | product code 32731ETAC
  • Actim Pancreatitis Controls | product code 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.

Materials

MDSAP 13485 and ISO 13485 can be found here.