New Erythropoietin (EPO) Assay Expands Anemia Immunoassay Test Menu

In November, Beckman Coulter received U.S. Food and Drug Administration (FDA) clearance of its erythropoietin (EPO)  assay, expanding the company's anemia menu on its Access® family of immunoassay systems. The new assay provides for the quantitative determination of erythropoietin (EPO) in human serum and plasma.

With the EPO assay, hospitals and reference laboratories have the ability to report rapid, accurate results that aid in the diagnosis of polycythemias, or overproduction of red blood cells. Measurement of EPO levels can assist physicians in differentiating polycythemias caused by conditions such as decreased oxygen in tissues from neoplastic bone marrow disorders.

The EPO test also aids in the diagnosis of anemia and helps to predict and monitor the response to recombinant EPO (rhEPO) treatment of anemia, such as cases of cancer-related anemia. High EPO levels may indicate that the patient will not respond to rhEPO therapy.

With expanding applications for EPO testing, the turnaround time provided by this automated assay on the Access family of immunoassay systems provides labs with a rapid, sensitive and precise method for measuring EPO.

The new test can be performed using serum or heparinized plasma and requires a sample volume of 85 µL. The liquid, ready-to-use reagent features an analytical sensitivity of less than or equal to 0.6 mIU/mL and total imprecision of less than or equal to 10 percent C.V. at EPO concentrations greater than 3 mIU/mL.

Time to first result is about 45 minutes. The assay offers 28-day calibration stability and 28-day open-pack stability.

Access EPO is available on Beckman Coulter's family of Access immunoassay systems, including the Access 2 and UniCel DxI 800, as well as the UniCel® DxC 600i and SYNCHRON LX®i 725 chemistry-immunoassay analyzers.

Besides EPO, Beckman Coulter's anemia immunoassay menu  includes tests for intrinsic factor antibody, vitamin B12, ferritin, folate and RBC folate. The menu also includes cancer, cardiac, infectious disease, reproductive and other endocrine tests for a total of approximately 50 tests worldwide.