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Determination of Fibrinogen Ratio Cutoff Limits Using Indirect Reference Interval Methodology.

Abdulrahman Saadalla^1,2, Kelly Doyle^1,2, Karen Moser^1,2

¹Department of Pathology, University of Utah School of Medicine, Salt Lake City, Utah, USA.

International Journal of Laboratory Hematology

|July 9, 2025

Summary

This summary is machine-generated.

Clinicians use fibrinogen antigen-to-activity ratios to detect dysfibrinogenemia. A new algorithm using large datasets accurately estimated ratio cutoffs, but overestimated reference interval limits for fibrinogen activity and antigen.

Keywords:

dysfibrinogenemia fibrinogen indirect ratio reference intervals

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Area of Science:

Clinical Chemistry
Hematology

Background:

Discordant fibrinogen antigen-to-activity ratios are key indicators for diagnosing dysfibrinogenemia.
Current laboratory cutoffs for these ratios are often based on limited validation studies.
There is a need for more robust methods to establish accurate diagnostic criteria.

Purpose of the Study:

To apply indirect reference interval (RI) methodology using large clinical datasets to determine reliable fibrinogen ratio cutoffs.
To evaluate the efficacy of the RefineR algorithm in establishing these diagnostic parameters.
To compare algorithm-derived cutoffs with existing validated laboratory standards.

Main Methods:

Analysis of two large datasets (n=3693 and n=2192) of patient results including fibrinogen antigen and activity measurements.
Utilized radial immunodiffusion (RID) and turbidimetry immunoassay for antigen quantification.
Applied the RefineR algorithm to estimate reference intervals and ratio cutoffs for fibrinogen.

Main Results:

Estimated fibrinogen antigen/activity ratio cutoffs closely approximated validated laboratory cutoffs (within 8% difference).
The RefineR algorithm significantly overestimated upper reference interval limits for both fibrinogen antigen and activity (38.4%-57.2%).
Estimated reference intervals were substantially wider than validated limits (41.8%-80%).

Conclusions:

The RefineR algorithm offers a viable method for determining fibrinogen ratio cutoffs using extensive clinical data.
The algorithm's inability to distinguish acute-phase reactants and its overestimation of RI limits require further refinement.
This approach enhances the potential for more accurate dysfibrinogenemia detection through large-scale data analysis.