All of our seasonal influenza antibodies are currently raised in sheep in the UK in controlled animal facilities under close veterinary supervision. However we can make no statement concerning the region of the UK from which the sheep were obtained. All sheep have an individual health certificate, confirming their disease free status, signed by a veterinary surgeon, which is attached to the IFU.

Antibody to Haemagglutinin (HA) is prepared by first cleaving off the HA antigen from live influenza virus using bromelain. This serves to inactivate the virus although no tests for effective inactivation are done.

The HA antigen inoculation schedule for the sheep is described in the IFU for the reagent.

Details of processing of the resultant sheep serum is described in the IFU.

At times when there were Foot and Mouth Disease outbreaks in the UK, the serum was treated to inactivate the FMD Virus using an APHIS approved method of holding at less than pH 5.5 for at least 30 minutes. This is described in the IFU and will apply to products with codes 01/nnn and 07/nnn. NIBSC cannot confirm that the product has been treated to inactivate FMDV according to any other procedure specified in an import permit.

At times when there has been no prevailing outbreak of FMD in the UK, the serum has not been treated in this manner and the IFU will not refer to this inactivation process. Again, NIBSC cannot confirm that these products have been treated to inactivate FMDV according to any procedure specified in an import permit.

Gamma irradiation will destroy these products and should not be used.

It is not possible to label each reagent ampoule or vial with a statement similar to "For in vitro use or use in laboratory animals only". However, where required and appropriate, such a statement can be applied to the shipping container.