The present invention relates to isolated monoclonal antibodies (mAbs) and/or antigen-binding fragments thereof that specifically recognize indoxyl sulfate, a protein-bound uremic toxin, isolated polynucleotide segments encoding the isolated antibodies and/or antigen-binding fragments thereof, and uses of such isolated anti-IS mAbs and/or antigen-binding fragments thereof to create immunoassay methods, device compositions, and pharmaceutical compositions applied in theragnosis of IS-related diseases.本發明有關於一種專一性辨識蛋白結合型尿毒素-硫酸吲哚酚(IS)之單離單株抗體及/或其抗原結合片段，編碼上述單離單株抗體及/或其抗原結合片段之單離聚核苷酸區段，利用上述單離抗IS之單株抗體及/或其抗原結合片段的免疫分析法、元件組成物暨其用於診斷及治療IS相關疾病的藥學組成物。
