TY - JOUR
T1 - Recommendations for the measurement of thrombin generation
T2 - Communication from the ISTH SSC Subcommittee on Lupus Anticoagulant/Antiphospholipid Antibodies
AU - Ninivaggi, Marisa
AU - de Laat-Kremers, Romy
AU - Tripodi, Armando
AU - Wahl, Denis
AU - Zuily, Stephane
AU - Dargaud, Yesim
AU - Cate, Hugo ten
AU - Ignjatovic, Vera
AU - Devreese, Katrien M. J.
AU - de Laat, Bas
N1 - Funding Information:
MN, RdLK and BdL are employees of Synapse Research Institute, part of Diagnostica Stago S.A.S. HtC has received research support from Bayer and Pfizer, is consultant to Alveron and stockholder in Coagulation profile. SZ reports, outside the submitted work, support to attend scientific meetings with honoraria for lectures from Alliance Bristol‐Myers Squibb‐Pfizer Pharmaceuticals, Aspen, Bayer Healthcare, and GlaxoSmithKline. YDhas received grants/research support from Bayer, Baxter, Baxalta, Novo Nordisk, CSL Behring, LFB, Pfizer, LeoPharma, Octapharma and Stago; an educational grant from Takeda and honoraria from Bayer, Baxt er, Novo Nordisk, CSL Behring, Sobi and Octapharma. KMJD, DW, AT, VI have nothing to disclose.
Publisher Copyright:
© 2021 International Society on Thrombosis and Haemostasis
PY - 2021/5
Y1 - 2021/5
N2 - Thrombin generation (TG) assay is an overall assay to assess the functionality of the hemostatic system and may be a useful tool in diagnosing patients with hyper- and hypocoagulability. Lack of standardization in performing the assays contributes largely to poor correlation between assays and study results. The current lack of standardization remains a major issue in the setting of TG, as illustrated in a recent survey of the ISTH/SSC indicating differences in pre-, analytical, and post-analytical factors among users. These factors may considerably affect the between-laboratory reproducibility of results. Based on the results of the survey and a current review of the literature, along with insights and strong consensus of key investigators in the field, we present guidance for measurement of TG in a clinical setting. Recommendations on blood drawing, handling, processing, and sample storage; reagent concentration and source; analytical conditions on dilution of samples and temperature; calibration and replicate testing; calculation and interpretation of results; and reference values are addressed to help in reducing interlaboratory variation. These recommendations aim at harmonization between methods and laboratories to support the application of TG in patient diagnosis and management.
AB - Thrombin generation (TG) assay is an overall assay to assess the functionality of the hemostatic system and may be a useful tool in diagnosing patients with hyper- and hypocoagulability. Lack of standardization in performing the assays contributes largely to poor correlation between assays and study results. The current lack of standardization remains a major issue in the setting of TG, as illustrated in a recent survey of the ISTH/SSC indicating differences in pre-, analytical, and post-analytical factors among users. These factors may considerably affect the between-laboratory reproducibility of results. Based on the results of the survey and a current review of the literature, along with insights and strong consensus of key investigators in the field, we present guidance for measurement of TG in a clinical setting. Recommendations on blood drawing, handling, processing, and sample storage; reagent concentration and source; analytical conditions on dilution of samples and temperature; calibration and replicate testing; calculation and interpretation of results; and reference values are addressed to help in reducing interlaboratory variation. These recommendations aim at harmonization between methods and laboratories to support the application of TG in patient diagnosis and management.
KW - clinical laboratory tests
KW - standardization
KW - thrombin
KW - thrombin generation assay
KW - thrombography
U2 - 10.1111/jth.15287
DO - 10.1111/jth.15287
M3 - Article
C2 - 33880866
SN - 1538-7933
VL - 19
SP - 1372
EP - 1378
JO - Journal of Thrombosis and Haemostasis
JF - Journal of Thrombosis and Haemostasis
IS - 5
ER -