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A system should exist in the country or region for approval of test systems, such as an offi cial approval system by the NRA or a delegated laboratory.
The required minimal sensitivity of tests for the different antigensantibodies or nucleic acids should be defi ned by the NRA.
9.5.1.2 Handling of samples and data
Multiple specimens may be collected from a donor in order to meet all testing requirements i.e. ABO typing, viral markers, NAT testing. There should be
written standard operating procedures that clearly describe the collection, transportation and labelling of donor samples i.e. whole blood, sera, anti-
coagulant, container tubes etc. and which defi ne the sampling procedure performed on material for analysis e.g. how and by whom it is done, transfer
of samples, accountability of samples. All screening activities, handling of donor specimens, sampling, analysis and data processing should be separated
from patient diagnostic testing 21.
Sample labelling at the site of collection and identifi cation during all subsequent processing is critical and should be under control at all times. Each
step of handling and processing should be described, as should the conditions of pre-analytical treatment of specimens e.g. centrifugation, storage and
transportation duration, temperature, type of container, storage after testing.
Serological testing should be performed on samples transferred directly into the analyser from the original sample tube.
Secondary aliquot samples may be used for NAT testing of mini-pools of individual samples.
The following practical points should be considered in order to ensure the traceability and integrity of samples and data:
• At receipt of specimens at the laboratory, positive identifi cation of those received versus those expected should be performed. The integrity of the
sample should be checked for compliance with the recommendations made by the manufacturer of the test kit.
• Aliquot samples for analysis should be withdrawn from the donor sample preferably by automated pipetting equipment.
• To provide for positive identifi cation of all aspects donation, donor specimen, aliquot samples etc. it may be advisable to use a barcode
system. Hence, starting with the donation, barcodes should be used for labelling. In case of failure of the automatic barcode reader system andor
data processors, an appropriate system should be available for manual entry and tracing of data throughout the whole process until release of donations
for transfusion. Manual handling of data should include independent repeat entry into the database; the data format should include a check-digit
algorithm or an automated test for identity of the two sets of data.
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• Pipetting devices and machines should be validated before routine use, and validation reports should be available.
• Calibration of the pipetting devices should be performed periodically and should be documented.
9.5.1.3 Testing and post-analytical procedures
