Transferrin Immunological Test System

Transferrin Immunological Test System utilizes immunological techniques to measure the level of transferrin, a protein in the blood responsible for transporting iron, within a patient’s serum or plasma, primarily used as an aid in diagnosing conditions related to iron deficiency anaemia (IDA) or malnutrition; essentially, it’s a blood test that detects the amount of transferrin present using antibody-based methods which uses an immunoassay technique like ELISA (enzyme-linked immunosorbent assay) where antibodies specific to transferrin bind to the protein in the sample, allowing for quantification.

Intended Use of Transferrin Immunological Test System

A Transferrin Immunological Test System is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anaemia.

Intended Use:

This assay aids in diagnosing Iron Deficiency Anaemia (IDA) and Anaemia of Chronic Disease (ACD). It can be used with Ferritin measurement to calculate a ferritin index. The Transferrin Immunological Test System measures transferrin levels in urine, aiding in the diagnosis of malnutrition, inflammation, infection, and red blood cell disorders.

Device Description:

The assay is a two-step immunoenzymatic assay for quantitative determination of transferrin in human urine. It uses paramagnetic particles coated with streptavidin: biotinylated soluble transferrin receptor monoclonal antibody and monoclonal mouse anti-human soluble transferrin receptor alkaline phosphatase conjugate. The assay consists of two reagent packs, each containing 50 tests for 100 determinations. The sample is added to a reaction vessel, and the antigen binds to the immobilized anti-sTfR antibody. The reaction is measured with a luminometer, and the light production is directly proportional to the analyte concentration in the sample. The analyte concentration is automatically determined from a stored calibration.

• Stability Studies
• Precision/Reproducibility
• Detection studies- Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ)
• Linearity/assay reportable range
• Traceability (controls, calibrators, or method)
• Retrospective Study
• Analytical Sensitivity
• Analytical Specificity (Cross Reactivity)
• Interfering Substances

Clinical Testing:

No Guidance available for 510k submission.