EDQM FAQs
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Serology and NAT studies
A laboratory is classified as ‘unsatisfactory’ if:
- one or more of the core-positive or core-negative samples is not correctly determined as ‘reactive’ or ‘non-reactive’, respectively;
- and/or the ratios interpreted from the raw data provided are not correct.
Immuno-haematology studies
A laboratory is classified as ‘unsatisfactory’ if at least one the core-positive samples is not correctly characterised/found to be negative.
Microbiology studies
A laboratory is classified as ‘unsatisfactory’ if:
- one or more of the positive or negative samples is not correctly determined as ‘contaminated’ or ‘non-contaminated’, respectively.
- in case the identification of contaminated samples is performed routinely, identification results have not been submitted, or the identification is not correct.