Calprotectin (CPT) Rapid Test (1 pc/box)

Calprotectin (CPT) Rapid Test for the Diagnosis of Inflammatory Bowel Diseases

The CPT (Calprotectin) Rapid Test (stool) assists in the diagnosis of inflammatory bowel diseases (IBD). Calprotectin is most commonly used as part of the diagnostic evaluation of patients with suspected chronic IBD, such as Crohn’s disease or ulcerative colitis.

Although these conditions differ in pathology and clinical presentation, both involve significant intestinal inflammation. Elevated fecal calprotectin levels can help differentiate between IBD and functional gastrointestinal disorders such as irritable bowel syndrome (IBS). This test kit is available for professional use only.

CPT Rapid Test Specification

Product Name: Calprotectin (CPT) Rapid Test Kit

Sample Type: Stool

Packaging: 1 pc/box

Format: Cassette

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd., 3RD FLOOR, BUILDING 4, NO. 1418 - MOGANSHAN ROAD, HANGZHOU, ZHEJIANG, 50 CHINA, imd.assuretech@diareagent.com

EC REP: Lotus NL B.V., Koningin Julianaplein 10, le Verd, 2595AA, The Hague, Netherlands, peter@lotusnl.com

Expiry Date: 2026-02

CPT Test Kit Contents

• 1 test cassette

• 1 sample dilution tube with buffer solution

• 1 user manual in English

Test Procedure

Please read the user manual carefully before performing the test. Collect the sample according to the instructions. Before use, ensure that all devices, reagents, samples, and/or controls have reached room temperature (15°C-30°C).

After sample collection:

1. Remove the test from the sealed pouch and place it on a clean, flat surface. Label the test cassette with the patient’s name or control ID. For best results, perform the test within one hour.

2. Break off the tip of the dilution tube using a tissue. Hold the tube vertically and dispense 3 drops of the solution into the sample well (S) of the test cassette.

   Avoid trapping air bubbles in the sample well (S), and do not allow any solution to spill into the result window. During the process, the color will migrate across the membrane.

3. Wait for the colored band(s) to appear. Results can be read within 5 minutes. Do not interpret the results after 10 minutes, as they will be considered invalid.

CPT Rapid Test Performance

• Relative Sensitivity: 97.8% (92.2%–99.4%)*

• Relative Specificity: 99.4% (96.4%–99.9%)*

• Overall Agreement: 98.8% (96.4%–99.6%)*

*95% Confidence Interval

Legal Notices

Professional Use

This product is an in vitro diagnostic (IVD) and intended exclusively for professional use by medical personnel. Use for self-testing is not permitted. The manufacturer/distributor accepts no liability for damages resulting from improper or unauthorized use.

Right of Withdrawal

In accordance with § 312g (2) No. 3 of the German Civil Code (BGB), there is no right of withdrawal for sealed goods which, for reasons of health protection or hygiene, are not suitable for return if their seal has been removed after delivery.

Disclaimer

The seller assumes no responsibility for compliance with legal regulations within the buyer’s procurement process. The seller’s responsibility is limited solely to the delivery of the ordered goods and the provision of information regarding their proper use.