Fibrinogen determination according to Clauss: commutability assessment of International and commercial standards and quality control samples
-
Antonius M.H.P. van den Besselaar
,
Claudia J.J. van Rijn
Abstract
Background:
Many clinical laboratories use a clotting rate assay according to Clauss for the determination of fibrinogen in citrated plasma. The aim of the present study was to assess the commutability of the current International Standard for fibrinogen (coded 09/264), three commercial fibrinogen standards, and 10 freeze-dried plasma quality control samples from various sources.
Methods:
Clotting rate assays according to Clauss were performed on three automated instruments (Sysmex CA1500, STA-Rack Evolution and ACL-Top 700), using three commercial thrombin reagents (Siemens, Stago, and Instrumentation Laboratory). Relationships between the results obtained with the three instruments were determined with 25 fresh-frozen plasma samples obtained from patients. The deviations of the assay results obtained with the freeze-dried samples were compared with the deviations obtained with the fresh-frozen samples, according to approved CLSI guideline C53A.
Results:
Freezing and thawing had no influence on the assay results. There were significant differences in the mean assay results (fibrinogen, g/L) for the fresh-frozen plasma samples between the three automated instruments: 2.51 (STA-Rack Evolution), 2.25 (ACL-Top 700) and 2.20 (Sysmex CA1500). Similar differences were observed for several freeze-dried plasma samples. Some freeze-dried plasma samples, including the International Standard, were out of the 95% confidence interval for the relationship between STA-Rack Evolution and Sysmex CA1500.
Conclusions:
Some freeze-dried plasmas including the international standard for fibrinogen are not commutable among automated instruments for fibrinogen clotting rate assays according to Clauss. Our results have consequences for all interested parties in the traceability chain (WHO, industry, external quality assessment schemes, clinical laboratories).
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved submission.
Research funding: This study was supported by the Section Coagulation of the Dutch Foundation for Quality Assurance in Medical Laboratories (SKML). Siemens Healthcare Nederland provided standard human plasma and Dade Thrombin Reagent, Stago BNL provided STA-Unicalibrator and STA-Fib reagent and Werfen Benelux (Netherlands) provided HemosIL Calibration Plasma and HemosIL Fibrinogen-C reagent, free of charge.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: Siemens Healthcare Nederland, Stago BNL and Werfen Benelux played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication. G.L.A. Reijnierse, M.J. Hollestelle, R.W.L.M. Niessen and F. Hudig are members of the Section Coagulation of the Dutch Foundation for Quality Assurance in Medical Laboratories (SKML).
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Articles in the same Issue
- Frontmatter
- Editorial
- High-sensitivity assays for cardiac troponins – continued
- Reviews
- The 99th percentile of reference population for cTnI and cTnT assay: methodology, pathophysiology and clinical implications
- Vitamin B1 in critically ill patients: needs and challenges
- Opinion Papers
- Point
- High-sensitivity cardiac troponin: do think twice, it’s not all right
- Counterpoint
- Terminology of cardiac troponin assays and data censoring
- Establishing consensus-based, assay-specific 99th percentile upper reference limits to facilitate proper utilization of cardiac troponin measurements
- Fast track protocols using highly sensitive troponin assays for ruling out and ruling in non-ST elevation acute coronary syndrome
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- Relationship between polymorphisms in the CRP, LEP and LEPR genes and high sensitivity C-reactive protein levels in Spanish children
- General Clinical Chemistry and Laboratory Medicine
- An approach for estimating measurement uncertainty in medical laboratories using data from long-term quality control and external quality assessment schemes
- Selecting multi-rule quality control procedures based on patient risk
- Moving sum of number of positive patient result as a quality control tool
- Multidisciplinary training activities for decreasing preanalytical mistakes in samples from primary care
- Harmonization protocols for TSH immunoassays: a multicenter study in Italy
- Circulating free light chain measurement in the diagnosis, prognostic assessment and evaluation of response of AL amyloidosis: comparison of Freelite and N latex FLC assays
- Serum prolactin revisited: parametric reference intervals and cross platform evaluation of polyethylene glycol precipitation-based methods for discrimination between hyperprolactinemia and macroprolactinemia
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- New perspectives on existing data in comparative measurements: a simple extension of the regression analysis
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