2018-02-28

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Rossix Factor IXa Calibrators are lyophilized preparations of human Factor IX intended for use with the Rox FIX-A kit. The Factor IXa Calibrator is calibrated against a WHO Factor IXa International Standard. FIXa Calibrator (Art No. 9599) and FIXa Control (Art No. 9588) are available from Rossix. Both products are potency assigned vs a WHO International Standard for FIXa and are provided in packages of 10 vials each. 5 Materials required but not provided Deionized water, filtered through 0.22 m or NCCLS Type II water or higher quality.

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Interchim There is no interference of FIXa in the kit method at a FIXa level of 0.6% of the total FIX content. 14 Contact Information Rossix Phone: +46 31 706 8965 Taljegardsgatan 3B Fax: +46 31 706 8966 SE-431 53 Molndal info@rossix.com Sweden www.rossix.com 15 References 1. 6th; ; To understand the variation in FIX activity levels, (Hyphen) and Rossix FIX CSAs on fully automated coagulation analysers View.

Rox Factor IX is a chromogenic kit for determination of Factor IX (FIX) activity in plasma and FIX containing concentrates. CE marked and approved for In Vitro Diagnostic Use in Europe and Australia. Outside Europe Rox Factor IX is available for In Vitro Research Use Only.

Manufactured by Rossix AB. FIXa Calibrator (Art No. 9599) and FIXa Control (Art No. 9588) are available from Rossix. Both products are potency assigned vs a WHO International Standard for FIXa and are provided in packages of 10 vials each. 5 Materials required but not provided Deionized water, filtered through 0.22 m or NCCLS Type II water or higher quality.

Rossix fix

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Manufactured by Rossix AB. Rox Factor IXa (950030) is for quantitative determination of human Factor IXa (FIXa) activity as contamination in human Factor IX (FIX) containing concentrates. Manufactured by Rossix AB. 2020-09-26 The FIXa Control is intended for use with the Rox FIX-A Kit, Ref 950030 (Rossix AB). 2. PROPERTIES Lyophilized preparation of human Factor IXa calibrated against the 2nd International standard for Activated Blood Coagulation Factor IXa (FIXa), Human, NIBSC code 14/316 using the Rox FIX-A kit Ref 950030. 3.

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Rossix fix

Vivien CHEN, Haematologist | Cited by 1,015 | of The University of Sydney, Sydney | Read 53 publications | Contact Vivien CHEN WHO/BS/10.2145 Page 2 Summary Twenty-nine laboratories from 14 different countries participated in a collaborative study to value assign the proposed 4 th International Standard for Blood Coagulation Factors II, VII, IX and X, Plasma (09/172) against the 3 rd International Standard for Blood Coagulation Factors II, VII, IX and X, Plasma (99/826). Rox Factor IX is a chromogenic kit for determination of Factor IX (FIX) activity in plasma and FIX containing concentrates. CE marked and approved for In Vitro Diagnostic Use in Europe and Australia. Outside Europe Rox Factor IX is available for In Vitro Research Use Only. Rox Factor IX is a chromogenic kit for determination of Factor IX (FIX) activity in plasma and FIX containing concentrates.

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Slope Slope Ratio FIXa activity FIXa / FIX Standard 0.0076 100% = 0.8 mIU FIXa /ml Sample 0.0035 0.46 0.46 x 0.8 = 0.368 mIU FIXa /ml 0.368 /0.5 = 0.736 mIU FIXa / IU FIX 9 Contact Information Rossix Phone: +46 31 706 8965 Taljegardsgatan 3B Fax: +46 31 706 8966 SE-431 53 Molndal info@rossix.com Sweden www.rossix.com rFIX-Fc is an extended half-life (EHL) recombinant FIX concentrate approved for the prophylaxis and treatment of bleeding events in haemophilia B. A high laboratory and reagent-specific variability is described for rFIX-Fc activity measurements, overall in lower FIX concentrations. To evaluate the Hyphen Biomed (Hyphen) and Rossix FIX CSAs on fully automated coagulation analysers and compare them to the FIX one‐stage assay (OSA).

The FIXa Control is intended for use with the Rox FIX-A Kit, Ref 950030 (Rossix AB). 2. PROPERTIES Lyophilized preparation of human Factor IXa calibrated against the 2nd International standard for Activated Blood Coagulation Factor IXa (FIXa), Human, NIBSC code 14/316 using the Rox FIX-A kit Ref 950030. 3. HANDLING

A minimum of two independent assays were run for each sample tested. Chromogenic assays Factor IX (Hyphen Biomed, Neuville sur Oise, France) and FIXa (Hyphen Biomed; Rossix AB, Mölndal, Sweden) assays were run according to the manufacturers’ instructions (kinetic method) on an ACL TOP 500 (Instrumentation Laboratory, Bedford, MA, USA). • FIXa generation was impaired with Actin FS. • The Rox Factor IX kit showed uniform FXa generation vs time for all three FIX preparations. • PEGylated BeneFIX shows the same FIX activation pattern as N9-GP with all three APTT reagents and thus FIXa formation during contact activation with APTT SP and impaired FIXa formation with Actin FS. FIX-Padua has been incorporated into AAV gene therapy vectors and has had the expected effect of boosting FIX activity (FIX:C) by 8-fold over similar vectors expressing FIXwt.

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