A Leak in the System: Addressing the Environmental Impact of Urologic Care.

As urologists we have an opportunity to reduce the carbon footprint of the procedures we perform. We highlight some areas of interest in urology and potential initiatives to reduce the energy and waste footprint of urology care. Urologists can and should make an impact on the growing climate crisis.

Enabling accurate measurement of activated factor XI (FXIa) in therapeutic immunoglobulin products.

Background And Objectives: In 2010, an intravenous immunoglobulin (IVIG) product was removed from the market due to an association with serious thromboembolic events. Investigations revealed that factor XIa (FXIa) was present as a process-related impurity. This study investigated the ability of two commercial FXIa assays to measure FXIa in immunoglobulin preparations and conducted a survey of FXIa activity in marketed immunoglobulin products.

The traceability of commercial plasma calibrators to the plasma International Standards for factor VIII and factor IX.

Accurate measurement of coagulation factors is essential, especially for diagnosis of deficiency. Clinical laboratories use commercially available plasma calibrators, which should be traceable to the relevant plasma International Standard (IS). This study assessed the relationship between the plasma IS for factors IX (FIX) and VIII (FVIII) and some commonly used commercial calibrators.

Calibration of the 7th British Working Standard for factors II, IX and X, concentrate.

Seven laboratories from 5 different countries participated in the calibration of the 7th British Working Standard (BWS) for blood coagulation factors II, IX and X. The candidate, 15/182, was assayed for Factors II and X potencies against the 4th International Standard (IS) for Factors II and X, Concentrate (11/126) and for Factor IX potency against the 5th IS for Factor IX, Concentrate (14/148). Intra-laboratory GCVs for all 3 factors were less than 10%, with the majority less than 5%.

Potency estimates for recombinant factor IX in the one-stage clotting assay are influenced by more than just the choice of activated partial thromboplastin time reagent.

The activated partial thromboplastin time (APTT) one-stage clotting (OSC) assay is used to potency label factor IX (FIX) therapeutics and to monitor the treatment of deficient patients. Studies have highlighted differences in potency estimates for FIX therapeutics depending on what activator type the APTT reagent contains. During the study to replace the 4th International Standard (IS) for FIX Concentrate, it was noted that for the recombinant FIX (rFIX) candidates, a potency difference of 20% was obtained by some between laboratories using the reagent DAPTTIN.

Establishment of the World Health Organization First International Standard for Factor XII, Plasma, Human.

Until recently, the role of factor XII (FXII) in hemostasis was not considered to be important since patients with FXII deficiency do not present with bleeding. The activation of FXII by agents including mast cells and platelet polyphosphates suggests that it may have a role in thrombogenesis. The inhibition of FXII therefore presents an option for antithrombotic therapy, and antibodies and inhibitors are already in development.

Establishment of the World Health Organization 2 International Standard for Factor XI, Plasma, Human.

The 1 International Standard (IS) for blood coagulation factor XI (FXI), plasma, has been successfully used for potency labeling of FXI therapeutics and for diagnosis of FXI deficiency in patients. With stocks of the 1 IS near depletion, a replacement is required. In addition to the functional activity value, assignment of an antigen value to the 2 IS would allow harmonization of antigen assay methods and differentiation of patients who have low functional activity but normal antigen FXI levels from patients who have both low functional and antigen FXI levels.