The Ferritin Test Kit (1x20ML Reagent) is an in vitro diagnostic (IVD) reagent system designed for the quantitative determination of ferritin levels in human serum or plasma. Ferritin is a crucial intracellular protein that stores iron, releasing it in a controlled fashion. Its measurement is vital for assessing the body's iron stores and diagnosing a range of conditions, including iron deficiency anemia, iron overload (hemochromatosis), inflammation, chronic liver disease, and certain malignancies.
This kit provides a highly reliable and efficient solution for clinical laboratories and research institutions seeking accurate ferritin level assessments on automated clinical chemistry analyzers.
Key Features & Benefits
Quantitative Accuracy: Delivers precise and reproducible results for confident clinical decision-making.
Reliable Performance: Optimized reagent formulation ensures consistent and stable performance across various automated platforms.
Broad Measuring Range: Capable of detecting ferritin levels across a wide clinical spectrum, from deficiency to overload.
Rapid Results: Designed for efficient processing on automated analyzers, providing timely diagnostic information.
Excellent Correlation: Shows strong correlation with established reference methods, ensuring clinical validity.
Optimized Stability: Long shelf-life and onboard stability minimize waste and maximize cost-effectiveness.
Convenient Format: Supplied in a ready-to-use liquid reagent format, simplifying laboratory workflow.
Cost-Effective: Efficient reagent utilization per test helps manage laboratory operational costs.
Intended Use
For in vitro diagnostic (IVD) quantitative determination of ferritin concentration in human serum or plasma. This test is intended for use by trained laboratory professionals as an aid in:
Diagnosis and monitoring of iron deficiency anemia.
Assessment of iron overload conditions like hemochromatosis.
Evaluation of acute and chronic inflammatory conditions.
Monitoring of iron status in patients with chronic kidney disease, cancer, or other chronic illnesses.
Principle of the Test
The Ferritin Test Kit utilizes a Latex-Enhanced Immunoturbidimetric Method.
Reaction: When a sample containing ferritin is mixed with specific anti-ferritin antibodies coated on latex particles, an antigen-antibody reaction occurs.
Formation of Immune Complexes: This reaction leads to the formation of insoluble immunocomplexes.
Turbidity Measurement: The resulting turbidity of the suspension is directly proportional to the concentration of ferritin in the sample.
Spectrophotometric Analysis: The increase in turbidity is measured spectrophotometrically at a specific wavelength (e.g., 570 nm or 600 nm) by an automated clinical chemistry analyzer.
Quantification: The ferritin concentration in the sample is then determined by comparing the measured absorbance change to a calibration curve generated from known ferritin calibrators.
Kit Contents
Each kit typically contains:
Ferritin Reagent (R1): 1 bottle x 20 mL
(Ready-to-use liquid reagent containing anti-ferritin antibodies on latex particles in a buffer solution)
Instruction for Use (IFU): 1 insert
Storage & Stability
Unopened Kit: Store at 2-8°C. Stable until the expiration date printed on the label.
Opened Reagent: Once opened and onboard the analyzer, the reagent is typically stable for up to X weeks/days (refer to IFU for specific stability) when stored at 2-8°C and protected from direct light and contamination.
Do not freeze. Freezing may cause irreversible damage to the reagent.
Specimen Requirements
Specimen Type: Human serum or plasma (heparin or EDTA plasma recommended).
Collection: Collect blood specimens using standard venipuncture techniques.
Preparation: Centrifuge specimens as soon as possible after collection (within 2 hours) to separate serum or plasma from cells.
Storage:
Room Temperature (15-25°C): Stable for up to X hours (refer to IFU).
Refrigerated (2-8°C): Stable for up to X days (refer to IFU).
Frozen (-20°C): Stable for up to X months (refer to IFU). Avoid repeated freeze-thaw cycles.
Interferences: Avoid highly lipemic, icteric, or hemolyzed specimens, as they may interfere with test results.
Materials Required But Not Supplied
Automated clinical chemistry analyzer capable of performing turbidimetric immunoassays.
Ferritin calibrators and controls (highly recommended for proper assay performance and quality control).
Quality control materials.
Pipettes and disposable tips.
Distilled or deionized water.
General laboratory equipment and consumables.
Warnings & Precautions
For In Vitro Diagnostic Use Only. Not for internal use or direct injection into humans or animals.
Professional Use Only: This product is intended for use by trained laboratory personnel in a professional laboratory setting.
Biological Hazards: Handle all human specimens and controls as potentially infectious biohazards. Follow universal precautions and appropriate safety procedures for handling and disposal.
Chemical Hazards: Reagents may contain components that are irritating. Avoid contact with skin, eyes, and mucous membranes. In case of contact, wash thoroughly with water.
Disposal: Dispose of all reagents, specimens, and contaminated materials in accordance with local, state, and federal regulations.
Read the Instruction for Use (IFU) completely before performing the test. Deviations from the IFU may lead to inaccurate results.
Ordering Information
Product Name
Catalog Number
Volume
Tests (Approx.)
Ferritin Test Kit (Reagent Only)
FERR-1234
1 x 20 mL
Variable
Ferritin Calibrators Set
FERR-CAL-567
6 x 1 mL vials
-
Ferritin Control Set
FERR-CON-890
2 x 1 mL vials
-
Note: The number of tests per 20mL reagent bottle is dependent on the specific analyzer and chosen assay protocol (e.g., reagent volume per test).
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