T/CSBT 008-2019 Active Group standards

T/CSBT 008-2019 Screening requirements for nucleic acid of blood-borne infectious pathogens that can be transmitted by transfusion

Publish Date: 2019-04-12 Implement Date: 2019-04-12 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CSBT 008-2019

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Laboratory medicine

Publish Date: 2019-04-12

Implement Date: 2019-04-12

Scope

Scope: This standard specifies the key influencing factors and performance verification requirements for nucleic acid screening technologies for pathogens transmitted by blood transfusion, including the performance requirements of nucleic acid screening reagents and the analysis of common problems in their application. Nucleic acid screening methods include polymerase chain reaction (PCR) technology and transcription-mediated amplification (TMA) technology. This standard is applicable to the verification evaluation of nucleic acid screening reagents and the quality control of routine testing; Main technical content: Key factors affecting detection results; the performance of nucleic acid detection reagents; result analysis and control measures for false positives caused by nucleic acid amplification products