CIRCULATING KIM-1 LEVELS FOR DETECTION OF PATHOLOGIES ASSOCIATED WITH INJURY TO, OR CANCER OF, THE KIDNEY

摘要

The present invention is directed to KIM-1 polypeptide as a plasma acute and chronic kidney injury and renal cell carcinoma biomarker, and methods and kits comprising the use of agents specific to KIM-1 for facilitating and enhancing the diagnosis of kidney injury or carcinoma. The present invention is based on the discovery that measuring KIM-1 levels in the blood is more accurate and reliable than measuring KIM-1 levels in the urine for the diagnosis of subjects with proximal kidney tubule injury or kidney cancer. The invention is directed to methods for diagnosis of acute kidney injury, chronic kidney disease (CKD), and renal cell cancer by determining and monitoring the levels of KIM-1 polypeptide in a blood sample, such as plasma or serum sample.

主权项

1. An assay for diagnosing kidney injury or Renal Cell Carcinoma (RCC) in a subject, comprising:
(i) detecting whether human KIM-1 polypeptide is present in a blood sample obtained from the subject by contacting the blood sample with an anti-KIM-1 antibody and detecting binding between the KIM-1 polypeptide and the anti-KIM-1 antibody; (ii) diagnosing the subject as having a kidney injury or Renal Cell Carcinoma (RCC) when the level of KIM-1 polypeptide detected in the blood sample is higher by a statistically significant amount than reference level for the KIM-1 polypeptide.