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Secondary Coagulation Standard Plasma
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THE SSC COAGULATION STANDARDS STANDING COMMITTEE

Anthony R Hubbard PhD, Chairman

Roster

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:  anthony.hubbard@nibsc.org

History of the SSC/ISTH Secondary Coagulation Standard Plasma


The SSC Coagulation Standards Standing Committee 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 Standing Committee 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 Lots #3 and #4. 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 and calibrants. 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 collaboration between the manufacturers of diagnostic reagents and the SSC.

The current lot of the SSC/ISTH Secondary Coagulation Standard Plasma is Lot #4 which has an expiry date of "End December 2020”.

Ordering Information

Producers of coagulation diagnostic reagents and calibrants are invited to submit orders to NIBSC. Customers will need to set up an account with NIBSC.


New customers will need to complete the new customer account form.
Existing customers can place orders by e-mail to Standards@nibsc.org or via the NIBSC on-line catalogue.
On-line orders are given priority and will normally be processed on the same day.

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:

£4.00 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 #4
Expiry End December 2020
Reconstitute with 1.0 ml purified water
Store in the dark between -20 °C to -70 °C
Caution: Human Blood Product

TABLE: Assigned values for the SSC/ISTH Secondary Coagulation Standard Lot #4



Analyte

Assigned value
(IU/vial)

Inter-lab variability
(GCV%)

No. of estimates

Factor II

0.91

2.6

28

Factor V:C

0.89

5.7

22

Factor VII:C

0.97

4.1

29

Factor VIII:C

0.88

4.2

27

Factor IX:C

1.05

3.4

29

Factor X:C

0.94

2.4

26

Factor XI:C

0.89

5.2

20

Factor XIII

  • Function
  • Antigen (A2B2 complex)

 

0.76
0.74

 

4.6
7.6

 

17
13

von Willebrand Factor

  • Antigen
  • Ristocetin co-factor
  • Collagen binding
  • Propeptide

 

1.16
0.84
1.08
0.97

 

5.9
14.2
6.4
2.5

 

22
12
8
8

Protein C

  • Function
  • Antigen


0.92

0.94

 

3.6

6.9

 

24

13

Protein S

  • Function
  • Free antigen
  • Total antigen

 

0.81
0.98
0.93

 

7.0
6.8
3.8

 

14
17
12

Antithrombin

  • Function
  • Antigen

 

0.92
0.93

 

2.3
4.4

 

26
12

Fibrinogen

2.79 mg/ml

3.8

22

GCV - geometric coefficient of variation

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