Erythropoietin Assay

Erythropoietin assays are in vitro diagnostic devices designed to quantitatively measure erythropoietin levels in human serum and plasma. These assays aid in diagnosing conditions such as anemia and polycythemia by evaluating erythropoietin concentrations.

An erythropoietin assay is a device that measures the concentration of erythropoietin (an enzyme that regulates the production of red blood cells) in serum or urine. This assay provides diagnostic information for the evaluation of erythrocytosis (increased total red cell mass) and anemia.

Intended Use: This assay is for the quantitative measurement of erythropoietin (EPO) levels in human serum and plasma (heparin). Designed for use with automated immunoassay systems, it serves as an aid in diagnosing anemias and polycythemias in clinical settings.

Device Description: The Erythropoietin (EPO) Assay is an in vitro diagnostic device designed to quantitatively measure erythropoietin levels in the human serum and plasma. This assay aids in diagnosing and monitoring anaemia, polycythemia, and other haematological disorders by evaluating erythropoietin concentration.

The assay typically utilizes immunoassay-based techniques, such as chemiluminescence, enzyme-linked immunosorbent assays (ELISA), or immunoturbidimetric methods, for high sensitivity and specificity. It may be used with automated or semi-automated analyzers for efficient and accurate results.

• Precision (Reproducibility and Repeatability)
• Accuracy
• Linearity
• Measuring range
• Sensitivity and Specificity
• Cross-reactivity
• Limit of Detection (LoD), Limit of Quantification (LoQ), Limit of Blank (LoB)
• Stability

The same is applicable for CE Marking under IVDR also.

Clinical Testing is mandatory for 510k submission and IVDR CE Marking