An international collaborative study to assign value for Total Factor XIII-B Subunit Antigen to the WHO 1st International Standard for Factor XIII Plasma, (02/206): Communication from the ISTH SSC Subcommittee on Factor XIII and Fibrinogen.

Raut, Sanj; Katona, Éva; Riches-Duit, Andrew; Coxon, Carmen; Muszbek, László; Schroeder, Verena; Rigsby, Peter (2022). An international collaborative study to assign value for Total Factor XIII-B Subunit Antigen to the WHO 1st International Standard for Factor XIII Plasma, (02/206): Communication from the ISTH SSC Subcommittee on Factor XIII and Fibrinogen. Journal of thrombosis and haemostasis, 20(2), pp. 525-531. Wiley-Blackwell 10.1111/jth.15596

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BACKGROUND

Factor XIII (FXIII)-B subunit measurements are required for the diagnosis and characterization of the type of FXIII deficiency. Furthermore, therapy for FXIII-A deficiency with recombinant FXIII (rFXIII-A) relies on available FXIII-B.

OBJECTIVE

To carry out a collaborative study to calibrate and assign value to the current WHO 1st International Standard (IS) FXIII Plasma for Total FXIII-B subunit, relative to locally collected normal plasma pools.

METHODS

Laboratories were instructed to use a validated method (specific ELISA antibodies provided) for assessment of Total FXIII-B subunit antigen potency. All laboratories used this method with one laboratory using an additional in-house method. Nine data sets were received from seven laboratories (37 assays in total), which provided a total of 35 valid estimates for this new assignment. Total FXIII-B subunit estimates were calculated relative to locally collected normal plasma pools, using an arbitrary value of 1.00 unit of Total FXIII-B subunit per ml, for each pool.

RESULTS

Combination of results produced an overall mean of 0.98 units/mL with an inter-laboratory variability (geometric coefficients of variation - GCV%) of 18.3% [95% confidence interval: 0.86-1.11]. Real-time and bench stability studies indicated good stability and preservation of the FXIII-B subunit analyte in the WHO 1st IS FXIII Plasma (02/206).

CONCLUSION

Following agreement by study participants, ISTH/SSC Experts, WHO-ISTH Liaison Group and the SSC Board, the WHO/ECBS established the current WHO 1st IS Factor XIII plasma (NIBSC code 02/206) by additionally assigning it with a Total FXIII-B subunit antigen value of 0.98 IU/ampoule, in October 2019.

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