The full-length long-acting product can

actually be potency labelled and monitored with both the chromogenic and one-stage assay, although the possibility of assay discrepancy when in clinical use has not been clarified. It remains to be seen if the European Pharmacopoeia will change its requirement and allow a FVIII product to be labelled with the one-stage clotting assay rather than the chromogenic one. The situation is more complex when it comes to clinical monitoring the new BDD long-acting PD-0332991 solubility dmso products. While scientifically measurement of FVIII activity with the chromogenic assay may be preferable as a single assay type can be used for all products, we believe it is unlikely to be universally adopted at least in the near future. It is clear that the different APTT assays behave differently with the various products and cannot be used interchangeably. It remains to be seen how clinical laboratories will be advised to monitor the new long-acting BDD concentrates when employing the one-stage clotting assays. Possible ways to manage the issue include the following: Specification of a particular APTT reagent for each concentrate that gives results closest to the chromogenic assay Usage of a product-specific standard Use a multiplication factor to convert the result with a specific APTT reagent to

a value close to the chromogenic result Potential problems can be envisaged with the recommendation to use specific APTT reagents, which include the need 上海皓元医药股份有限公司 to secure the MLN8237 nmr long-term supply of these reagents produced by a different manufacturer and the demonstration that the same results are obtained with all FVIII-deficient plasmas, international standards and instrument combinations provided the one APTT reagent is used. Although

the multiplication factor method is attractive due to its simplicity, it is likely that each APTT reagent will need a different value ascribed to it and the problem with the long-term supply of a stable unchanged APTT reagent also apply. Looking into the future, it is likely that haemophilia centres will have patients on many different clotting factor concentrates, both standard and long-acting and full-length as well as BDD FVIII concentrates. This is likely to mean that haemophilia centres will have several one-stage clotting FVIII assays to monitor their patients. Centres should also be prepared to use the chromogenic in addition to the one-stage assay. Although the possibility of clinical laboratories offering more than one FVIII assay may appear new and novel to many haemophilia treaters that they will have to encompass due to necessity, as we have indicated at the start of this editorial, this has been necessary for quite some time in the diagnosis of mild haemophilia A.