Instruction for use for: CalproSmart™ RUO Self-Test For measurement of fecal Calprotectin

CalproSmart™ RUO Kit for measurement of fecal calprotectin 1 INTENDED USE The CalproSmart™ RUO test is a method for the determination of Calprotectin levels in human stool samples in combination with the dedicated CalproSmart™ RUO smartphone applications. For Research Use Only. 2 BACKGROUND Calprotectin is a 24 kDa dimer1 formed by the monomers S100A8 (10,835 Da) and S100A9 (13,242 Da)2,3. Calprotectin has a high affinity for calcium, zinc4, produced by PMNs, monocytes and squamous epithelial cells (except those in normal skin)Click or tap here to enter text.6. After binding of calcium, it can...

D) Support frame: Rectangular plastic frame with an opening for placement of the rapid test cassette, labelled with a design that allows the smartphone app to identify the position of the control and test line and read the test result. Materials and equipment required but not supplied 1. Paper tissue - sheet or towel 5 STABILITY AND STORAGE When stored unopened at 2 – 8°C, kit reagents are stable up to the expiry date stated on the label. Avoid exposure to high temperature and direct sunlight. 6 REGISTRATION AND DOWNLOAD OF THE APPLICATION 6.1 CalproSmart standalone application Upon registration...

Once completed setting the password, the lay-user can download the CalproSmart app. Download the app from App Store or Google Play by searching for “CalproSmart” or by scanning the QR code to the right and selecting the appropriate operating system. Ensure that the logo is identical to the one shown to download correct version of the app. When the user logs on using their credentials for the first time, they will have to accept the EULA (End User Licence Agreement) in order to use the app. Unpack and prepare 1 sampler, 1 pair of nitrile gloves, 1 prefilled extraction device, 1 rapid test and...

1. Put up the toilet seat before EasySampler is mounted and dry off the toilet bowl so the EasySampler can be mounted on a clean and dry surface. 2. Unfold the EasySampler. Remove the two tape protections from the EasySampler and mount them on the back of the bowl. 3. Remove the remaining tape protection and mount the front part of the EasySampler at each side in mid position of the bowl, leaving space to dispose toilet paper in front of EasySampler. It is important that the EasySampler is mounted so it creates a sample area. • Important: EasySampler must NOT touch the surface of the water. 4....

Important: Normally you will see the applied liquid move in the cartridge window. If this is not observed within 30 seconds, add one additional drop of extract to obtain normal flow. 1. Hold the Smartphone horizontally over the support frame with the embedded rapid test. 2. The picture is taken automatically when the barcode, Test line and Control line is identified by Smartphone application. 3. The results will be stored automatically Once the test has been measured. Depending on the study type (non-blinded/blinded), you may see a numerical value for the results or receive a confirmation of...

Procedure: It is important to follow the instructions carefully to get an accurate result. Both grooves in the rod of the extraction device should be completely filled. If possible, insert the rod repeatedly in different places in the stool. Avoid filling the grooves with air bubbles. Also avoid grains, fiber, etc. For very liquid stools, insert the rod deep into the sample to ensure the grooves are completely filled. It is not a problem if the grooves are overfilled. The extra material will be scraped off as you insert the rod back in the extraction device. Extraction device should be held vertically...

1. Johne B et al.: Functional and clinical aspects of the myelomonocytic protein calprotectin. J Clin Pathol: Mol Pathol 1997; 50:113-123. 2. Fagerhol MK et al.: Calprotectin (The L1 leukocyte protein) in: Smith VL and Dedman JR (eds): Stimulus response coupling: The role of intracellular calcium-binding proteins. CRC Press, Boca Raton 1990, p. 187210 3. Roseth AG et al.: Assessment of the neutrophil dominating protein calprotectin in faeces. Scand J Gastroenterol 1992; 27: 793-798. 4. Dale I et al.: Purification and partial characterization of a highly immunogenic human leukocyte protein, the...

CalproSmart™ RUO are available in one-test kit size. For a complete list of all product variants with product code, please visit our web page: www.calpro.no. Arnstein Arnebergs vei 30 N-1366 Lysaker, Norway Tel: +47 40 00 42 79 [email protected] www.calpro.no