THE SSC WORKING GROUP ON COAGULATION STANDARDS

Ordering Information · IFU Lot #3  ·  Calibrated Potencies Table · Roster

THE SSC WORKING GROUP ON COAGULATION STANDARDS

Anthony R Hubbard PhD, Chairman

Contact details:
Haemostasis Section
Biotherapeutics Group
National Institute for Biological Standards and Control
Blanche Lane, South Mimms
Potters Bar, Hertfordshire. EN6 3QG
United Kingdom
Tel: +44 (0) 1707 641318
Fax: +44 (0) 1707 641050
E-mail: thubbard@nibsc.ac.uk

History

The SSC Working Group on Coagulation Standards was formed as a result of a meeting between SSC members and Diagnostic Manufacturers to discuss the need to offer a uniform plasma standard for use by the manufacturers in labeling their coagulation calibrators. To achieve this goal, the Working Group was established and is presently composed of an Executive Board, the participating Diagnostic Manufacturers, and a panel of Expert Laboratories to label the analytes. Bids to produce the SSC/ISTH Secondary Coagulation Standard Plasma are invited from interested manufacturers. The Executive Board reviews the bids and selects the supplier. Baxter/Immuno, Vienna, produced Lots #1 and #2; Technoclone Gmbh, Vienna, produced Lot #3. Storage, labeling and dispatch of the SSC/ISTH Secondary Coagulation Standard is handled by NIBSC ( Potters Bar, UK). The SSC/ISTH Secondary Coagulation Standard is available to manufacturers of coagulation diagnostic reagents. The Standard was calibrated against WHO International Standards by multiple laboratories (see Table for assigned values and estimates of inter-laboratory variability). This reagent is the result of a collaboration between the manufacturers of diagnostic reagents and the SSC.

The current lot of the SSC/ISTH Secondary Coagulation Standard Plasma is Lot #3 which has an expiry date of 31 December 2014.

Ordering Information
Producers of coagulation reagents may order from Anthony R Hubbard at the above address.

Order size:       Minimum of 100 vials and multiples of 50 vials thereafter

Delivery:          Within 3 weeks of receipt of order; material will be shipped by courier at customer's expense. Material will be shipped at ambient temperature for immediate storage between -20 °C to -70 °C.

Price:                £2.80 GBP per vial handling charge plus cost of courier despatch
                          (a single invoice will be raised to cover above costs)

Payment:          30 days after invoice

Labelling:         SSC/ISTH Secondary Coagulation Standard Lot #3
                          Expiry End December 2014
                          Reconstitute with 1.0 ml purified water
                          Store between -20 °C to -70 °C
                          Caution: Human Blood Product

TABLE: Assigned values for the SSC/ISTH Secondary Coagulation Standard Lot #3

Analyte	Assigned value (IU/ml)	Inter-lab variability (GCV%)	No. of estimates
Factor II	0.86	6.3 %	13
Factor V:C	0.87	3.6 %	23
Factor VII:C	0.87	6.8 %	11
Factor VIII:C	0.80	4.7 %	17
Factor IX	0.94	4.6 %	15
Factor X	0.86	4.1 %	13
Factor XI	0.88	3.1 %	26
Factor XIII	0.71	8.6 %	23
von Willebrand Factor: Antigen Ristocetin Cofactor Collagen Binding	1.06 0.86 1.07	5.7 % 4.9 % 11.2 %	11 7 9
Protein C Antigen Function	0.89 0.89	2.2 % 4.2 %	9 25
Protein S Total antigen Free antigen Function	0.85 0.88 0.78	8.1 % 4.5 % 4.9 %	10 9 7
Antithrombin Antigen Function	0.95 0.93	2.4 % 2.8 %	5 12
Fibrinogen	2.58 mg/ml	5.0 %	11

GCV - geometric coefficient of variation