Actim® Pancreatitis
Ruling out acute pancreatitis in a timely manner.
Overview
Trypsinogen-2 and acute pancreatitis
Actim® Pancreatitis is a visually interpreted and manual qualitative immunochromatographic rapid test for the screening of acute pancreatitis.
The Actim Pancreatitis® test detects trypsinogen-2 in urine, which is a pancreatic enzyme with strongly elevated levels in patients with acute pancreatitis. The test is intended for professional use in a clinical laboratory or near the patient, and can be used as an aid in the diagnosis of acute pancreatitis in any patient who, in the opinion of a medical professional, would benefit from screening for acute pancreatitis.
Acute pancreatitis is an inflammatory condition associated with high morbidity, mortality, and hospitalization costs. Early treatment of acute pancreatitis is critical, but the non-specific symptoms related to this condition can make the diagnosis challenging.
Based on the unique biomarker trypsinogen-2, Actim Pancreatitis is the only rapid test that can identify acute pancreatitis at any phase of the inflammation. As a result, severe acute pancreatitis can be diagnosed at an early stage and treatment can be started promptly.
Actim Pancreatitis in a nutshell
Based on highly specific monoclonal antibodies that detect trypsinogen-2.
Can be performed at any stage of the inflammation.
Test result available in just 5 minutes.
Innovation behind Actim® Pancreatitis
Actim Pancreatitis detects trypsinogen-2, a reliable analyte for ruling out acute pancreatitis.
Actim Pancreatitis 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 detectable in all stages of the 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 and early asymptomatic pancreatitis.
Thanks to its extremely high (99%) negative predictive value (NPV), Actim Pancreatitis can reliably rule out pancreatitis even in asymptomatic patients.
About trypsinogen-2
- Trypsinogen-2 is produced by pancreatic acinar cells.
- It is secreted into the pancreatic juice as a proenzyme.
- Urinary trypsinogen-2 levels are highly elevated in acute pancreatitis, and they remain elevated for days or even weeks.
Table 1. Actim Pancreatitis surpasses both lipase and amylase testing in detecting and ruling out pancreatitis with 100% sensitivity (Jang et al., 2007).
Table 2. Actim Pancreatitis is a highly sensitive and specific screening tool for acute pancreatitis. With a high NPV, Actim Pancreatitis can be used to confidently identify patients that are not experiencing pancreatitis, also among those at risk of post-ERCP or post-pancreatic surgery acute pancreatitis.
At a glance
There is currently no gold standard for diagnosing acute pancreatitis. Actim Pancreatitis is a reliable point-of-care test for ruling out acute pancreatitis because it is:
- Based on trypsinogen-2, which, unlike amylase, is specific to the pancreas and stays elevated even for weeks.
- More sensitive than lipase-based tests.
- Easy to perform, cost-efficient, and radiation-free, as opposed to CT scans.
Furthermore, Actim Pancreatitis can be used to rule out pancreatitis resulting from pancreatic surgery, allowing low-risk patients to be discharged soon after the procedure*.
*S. Räty, J. Sand and I. Nordback. Detection of postoperative pancreatitis after pancreatic surgery by urine trypsinogen strip test. British Journal of Surgery (2007) 94: 64–69.
How to use the test
How to use Actim Pancreatitis
All the items required by healthcare professionals to perform the test are included in the test kit. What’s more, Actim Pancreatitis can conveniently be stored at room temperature (+2… +25 °C).
Learn how to use the test in the video below:
1. & 2. Activate the test
Once a minimum of 500 μl of urine sample has been collected, place the yellow dip area into the sample and hold it in place until you see the liquid front enter the result area.
Remove the dipstick from the sample and place it in an horizontal position.
3. Interpret the test result
- 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.
Product information
Actim Pancreatitis
The Actim Pancreatitis test kits are available in two package sizes. All test kits contain:
- Individually packed dipsticks
- 1 Instructions for Use document
Actim Pancreatitis Controls
The 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 as well as weak and strong positive results.
The control kit includes negative, low positive and high positive controls as well as a reconstitution solution.
Product codes
- Actim Pancreatitis, 20 tests | product code 32732ETAC
- Actim Pancreatitis, 10 tests | product code 32731ETAC
- Actim Pancreatitis Controls | product code 32700ETAC
Materials
Downloadable materials
- Brochures & leaflets
- Brochure
- Technical specifications leaflet
- Instructions for use
- Actim Pancreatitis instructions for use
- Actim Pancreatitis Controls instructions for use
- Scientific materials
- List of publications mentioning Actim Pancreatitis
- Material safety data sheet
- If you wish to receive a Material safety data sheet, please contact: regulatory@actimtest.com
Actim® Pancreatitis is not registered in the USA.
MDSAP 13485 and ISO 13485 can be found here.