Acceptance testing should be performed on each batch/delivery of reagents and test kits.
Reagents and test kits should be stored and used according to the manufacturer’s instructions.
Reagents and test kits outwith these instructions must be validated.
Reagent antisera must be validated and assured for specificity and potency as per Table 11.3.
A system of inventory control must be in place that records, as a minimum, the reagent or test kit:
Procedures should ensure the traceability of the batch number and manufacturer of reagents and kits and, if relevant, the serial number of equipment used to test every donation.