This document specifies the verification requirements and verification methods involved in the performance verification of blood screening nucleic acid tests. This document is suitable for use by nucleic acid testing laboratories such as blood collection and supply institutions, medical institutions, and centers for disease control and prevention. Note: Blood screening and nucleic acid testing in this document mainly refers to nucleic acid screening and testing of infectious pathogens transmitted through blood transfusion.
T/CAME 38-2021 history
2021T/CAME 38-2021 Performance validation of nucleic acid testing in blood screening