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  • Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sample (e.g., serum, bronchoalveolar lavage) to determine an oncofetal soft keratin (i.e., cytokeratin) fragment 18 antigen, referred to as tissue polypeptide specific (TPS) antigen, frequently found in the serum of patients with malignant tumors. The determination of the level of the TPS marker (cytokeratin 18) is used in treatment monitoring and prognosis evaluation of several types of malignancies, including bladder and thyroid cancer; the level of TPS can also be used to differentiate cholangiocarcinomas from hepatocellular carcinomas.
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