Optimized High Accuracy, Fast IVD One Step Test Calprotectin Rapid Box Test for OEM/ODM

【Possible use】 The Calprotectin Rapid Test is an in vitro qualitative immunochromatographic assay for the rapid detection of calprotectin in human feces. The product provides a simple, highly sensitive and non-invasive screening method to determine intestinal inflammatory activity, monitor response to treatment and predict risk of relapse. 【Test principle】The kit uses the double-antibody sandwich method. Gold mouse anti-human calprotectin monoclonal antibody 11F10, mouse anti-human calprotectin monoclonal antibody 2D1 and goat anti-mouse IgG polyclonal antibody were coated on test strips to qualitatively detect calprotectin in human feces. When the test sample is positive, the calprotectin in the sample binds to the colloidal gold-labeled antibody, and the conjugate moves forward under the action of the siphon, forming an antibody-antigen-antibody-colloidal gold complex with the pre-coated antibody. The test line appears red; free colloidal gold-labeled antibody is stained by binding to the polyclonal antibody at the quality control line. Negative samples are colored only at the quality control line.

【Specimen Collection】1. The container for collecting samples should be clean and free from other biological or chemical components. 2. Freshly collected untreated samples can be stored at room temperature (18-24°C) for 7 days. If tested in short order, they can be stored in the refrigerator at 2-8⁰C for 14 days.【Storage and shelf life】This test product should be stored in a cool, dark, and dry place at 4-30°C, and the validity period is 24 months; the test paper should be used within 1 hour after opening the aluminum foil bag at room temperature (18-24°C); 30℃) It can be stored stably for 25 weeks if the box is closed immediately after taking out the test paper; the production date is shown in the aluminum foil bag and the outer box label.【Test method】 1. Specimen preparation (1) Take out the sampling rod in the sample processing tube, take the feces as shown in Figure 1, take about 15 mg of solid feces sample and put it into the sample processing tube containing 1.5 mL of diluent. For liquid samples, transfer 15 µL of the fecal sample with a micropipette to a sample processing tube containing 1.5 mL of diluent. (2) Tighten the cap of the tube, and shake the sample processing tube as shown in Figure 2 to fully mix the sample; the processed sample can be stored in a refrigerator at 2-8°C for detection within 7 days. 2. Operation steps Equilibrate the stool sample to room temperature (18-24°C) before the test, and do not tear the aluminum foil bag before the performance test.

【Interpretation of results】 1. Positive: Color bands appear in both the detection area (T) and the control area (C), and the test result is positive. 2. Negative: Only one color band appears in the control area (C), and the test result is negative. 3. Invalid: No color band appears in the control area (C) or only one color band appears in the detection area (T), indicating that the test is invalid and the test should be repeated.