Evaluation of a standardized protocol for thrombin generation using the calibrated automated thrombogram: A Nordic...

Area of Science:

• Coagulation science
• Clinical chemistry
• Laboratory diagnostics

Background:

• The thrombin generation assay-calibrated automated thrombogram (TGA-CAT) measures overall plasma coagulation capacity.
• Current lack of standardization limits TGA-CAT's use as a research tool.

Purpose of the Study:

• To enhance TGA-CAT standardization through a detailed protocol.
• To evaluate the efficacy of three reference plasmas (RPs) in normalizing TGA-CAT results.

Main Methods:

• Six Nordic centers collaborated to establish a detailed laboratory standardization protocol for TGA-CAT.
• Hypo-, normal-, and hypercoagulable plasmas were analyzed.
• Three commercial lyophilized RPs were used for data normalization.

Main Results:

• Before normalization, inter-laboratory variability was generally low (≤10%), with exceptions for endogenous thrombin potential and peak in hypocoagulable plasma.
• Normalization using HemosIL RP and Affinity RP significantly improved result variability.
• One RP did not effectively normalize results.

Conclusions:

• The developed standardization concept yielded TGA-CAT results comparable to routine coagulation assays.
• HemosIL RP is suitable for normalizing samples from populations with low or unknown coagulability.
• Affinity RP is recommended for analyzing plasma samples from populations with known or suspected hypercoagulability.