Latex agglutination test for ferritin measurement

Area of Science:

• Clinical Chemistry
• Hematology
• Immunodiagnostics

Background:

• Ferritin is a critical biomarker for diagnosing iron deficiency anemia and siderosis.
• Accurate and efficient ferritin measurement is essential for clinical practice.
• Existing methods may require specialized equipment or longer turnaround times.

Purpose of the Study:

• To evaluate the clinical utility of a novel reagent for ferritin measurement using a latex agglutination (LA) test.
• To assess the performance of the LA test on general chemistry analyzers.
• To determine the reliability and accuracy of the LA assay for ferritin quantification.

Main Methods:

• Evaluation of intra-assay and inter-assay coefficients of variation (CV).
• Assessment of linearity, effective sensitivity, prozone effect, and interference.
• Correlation analysis with the enzyme immunoassay (EIA) method and C-reactive protein.
• Comparison with liver-related biochemical parameters (AST, ALT) in patients with liver dysfunction.

Main Results:

• Excellent precision with intra-assay CV (0.8-3.4%) and inter-assay CV (0.0-0.7%).
• Demonstrated linearity up to 1100 ng/mL with an effective sensitivity of 4.0 ng/mL.
• Significant positive correlation with C-reactive protein (r=0.586, P<0.001) and parallel variation with liver parameters (AST, ALT).

Conclusions:

• The latex agglutination (LA) assay system provides accurate ferritin measurement across a wide range.
• This assay is suitable for diagnosing conditions including cancer, siderosis, and iron deficiency anemia.
• The LA test offers rapid, convenient, and simultaneous measurement of iron deficiency anemia markers on general chemistry analyzers.