Actim® Pancreatitis

Overview

A new way for healthcare professionals to diagnose acute pancreatitis in a timely manner

Actim^® Pancreatitis is a unique point-of-care test that has been developed to help healthcare professionals screen acute pancreatitis on the spot.

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 non-specific symptoms make diagnosing this condition particularly challenging.

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

Actim Pancreatitis in a nutshell

Actim Pancreatitis is a point-of-care test that allows healthcare professionals to rule out acute pancreatitis from one urine sample.
The test can be performed at any stage of the disease.
It is more sensitive and specific than amylase and lipase tests.
Actim Pancreatitis is an easy-to-use test performed by healthcare professionals that gives test results in just 5 minutes.
The test kit contains all the materials healthcare professionals need to perform the test, no extra laboratory resources or sample processing are required.
Actim Pancreatitis 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

The 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 in all the stages of a 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 and early asymptomatic pancreatitis.

Because Actim Pancreatitis is a 100% sensitive test, it identifies the risk of acute pancreatitis also in patients who would likely be missed if using amylase or lipase tests.

Thanks to 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

Trypsinogen-2 is produced by pancreatic acinar cells.
It is 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 test	100	96
Lipase 3N	53	99
Amylase 3N	41	95

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

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	10

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 even for weeks.
More sensitive than lipase-based tests.
Easy to perform, cost-efficient, and radiation-free, as opposed to CT scans.

Actim Pancreatitis is the first and only dipstick test that enables the diagnosis of acute pancreatitis on the spot – without the need for sample processing or laboratory equipment. A 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 valuable resources

Actim Pancreatitis is a rapid test that has been developed for quick and reliable screenings conducted by healthcare professionals.
With this test, a timely medical attention can be directed to patients who need it.
Unnecessary expensive CT scans can be avoided.
No laboratory facilities are required to perform the test or to interpret the test results.
Actim Pancreatitis reduces avoidable hospital visits and patient transfers.

How to use it

How to use Actim Pancreatitis

Actim Pancreatitis kit contains all the materials needed to perform the test and it can conveniently 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.

Diagnosing acute pancreatitis in a timely manner.