[The evaluation of lyophilized plasma as a reference standard for the prothrombin complex]

Area of Science:

• Biochemistry
• Hematology
• Clinical Diagnostics

Context:

• Accurate assessment of prothrombin complex factors is crucial for diagnosing and managing coagulation disorders.
• Standardized reference materials are essential for ensuring consistency and comparability of laboratory test results.
• Lyophilized plasma offers advantages in terms of stability and shelf-life compared to fresh plasma.

Purpose:

• To evaluate the stability and suitability of a lyophilized donor plasma reference sample for assessing prothrombin complex factors.
• To establish the utility of this reference sample for estimating prothrombin complex factor activities and PPSB (Prothrombin, Protein C, Protein S, and Beta-thromboglobulin) activity.
• To determine the optimal method for estimating the activity of the reference sample using fresh donor plasma.

Summary:

• Analysis confirmed the stability of a lyophilized donor plasma reference sample over a 14-month follow-up period.
• The sample is suitable for use as a reference in the estimation of plasma prothrombin complex factor activities and PPSB activity.
• Reference sample activity should be determined from a fresh donor plasma native pool with a standardized procoagulant activity (100% or 1 U/ml).

Impact:

• The use of this stable lyophilized reference sample can lead to more objective and nationally compatible results in coagulation testing.
• Standardization of biological reagents within test systems, alongside this reference sample, enhances the reliability of diagnostic assays.
• Facilitates consistent quality control in clinical laboratories performing prothrombin complex factor assays.