[Fibrinogen determination by the Clauss method. Reagents and analyzers]

Area of Science:

• Clinical chemistry
• Hematology
• Coagulation diagnostics

Context:

• The World Health Organization (WHO) recommends the Clauss method for plasma fibrinogen measurement.
• Accurate fibrinogen level determination is vital for diagnosing and managing hemostatic disorders.
• Evaluating the performance of specific diagnostic kits on diverse laboratory platforms is essential.

Purpose:

• To assess the applicability of RENAM Research-and-Production Association's test systems for fibrinogen measurement using the Clauss method.
• To evaluate the performance of these test systems across different clinical laboratory analyzers.
• To determine the importance of calibration curves for accurate fibrinogen quantification.

Summary:

• The study evaluated RENAM test systems for plasma fibrinogen measurement via the Clauss method on multiple clinical analyzers.
• Accurate calibration lines were identified as critical for obtaining correct results on each coagulometer.
• The findings indicate that RENAM test systems, when used with proper calibration, provide accurate and reproducible fibrinogen concentration measurements.

Impact:

• This research validates the use of RENAM test systems for reliable fibrinogen testing in clinical laboratories.
• It highlights the importance of robust calibration protocols for ensuring diagnostic accuracy with the Clauss method.
• The findings support the use of these systems for consistent and dependable hemostasis testing across various analytical platforms.