| 摘要 |
The invention relates to a test kit for better carrying out a method for detecting biomarkers in human or animal stool, which can serve as an indication of a pathological, particularly a malignant event in the gastrointestinal tract (esophagus, stomach, small bowel, biliary tract, pancreas, and bowel).;The invention teaches a novel and more efficient methods, uses and embodiments of a combined rapid test. The combined rapid test cassette used for implementing the test kit and the optimally coordinated reagents thereof contains two lateral flow test strips for the synchronous—in the technical meaning—detection of the biomarkers M2-PK and the biomarker hemoglobin.;The test serves as a “dual filter” for diagnosing probands as part of a colon cancer screening program. The test is very cost-efficient and cuts costs in the health system by the examination at an early stage of colon cancer and the consequences thereof. |
| 主权项 |
1. A test kit for detecting biomarkers in human stool, consisting of
a first sample tube, containing a first stool sampling device, a first buffer solution, containing buffer 1=10-70 mM phosphate buffer (pH 6.7 to 7.6) or buffer 2=10-70 mM HEPES buffer (pH 7.6 to 8.2) or buffer 3=10-70 mM triethanolamine (pH 7.3 to 7.7) or buffer 4=10-70 mM acetate buffer (pH 5.7), or mixtures thereof, a second sample tube, containing a second stool sampling device, a second buffer solution, buffer 1=10-70 mM phosphate buffer (pH 6.7 to 7.6) or buffer 2=10-70 mM HEPES buffer (pH 7.6 to 8.2) or buffer 3=10-70 mM triethanolamine (pH 7.3 to 7.7) or buffer 4=10-70 mM acetate buffer (pH 5.7), or mixtures thereof, a test cassette, containing a lateral flow test system with a nitrocellulose membrane as the stationary phase, the nitrocellulose membrane, in turn, containing monoclonal tumor M2-PK mouse antibody (clone PA-TAM3AT, IgG1), and gold-coupled monoclonal mouse antibody (clone 1 E3, IgG1), and hemoglobin antibody, preferably monoclonal hemoglobin mouse antibody (clone M1202100, IgG1), and gold-coupled monoclonal mouse antibody (clone HB11-2312), a first opening for applying a stool sample from the first sample tube, a second opening for applying a stool sample from the second sample tube, wherein the analysis result of the first stool sample is positive if the amount of tumor M2-PK is greater than 4±1 units/ml stool extract, and the analysis result of the second stool sample is positive, if the content of hemoglobin exceeds 24 μg hemoglobin per gram of stool. |
