GB/T 12715-1991
Abolished
T/LTIA 09-2020
Active
Group standards
T/LTIA 09-2020 The quality evaluation requirements for SARS-CoV-2 nucleic acid qRT-PCR detection reagent kit
T/LTIA 09-2020 The quality evaluation requirements for SARS-CoV-2 nucleic acid qRT-PCR detection reagent kit
Price:
$ 20.00
Basic Information
Standard Code:
T/LTIA 09-2020
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Biology, botany, and zoology
Publish Date:
2020-06-08
Implement Date:
2020-07-08
Scope
Scope: This standard specifies the terms and definitions, evaluation requirements, evaluation indicators, and evaluation methods for the quality evaluation of qRT-PCR detection kits for the novel coronavirus (SARS-CoV-2). This standard applies to the quality evaluation of qRT-PCR detection kits for the novel coronavirus (SARS-CoV-2). Main technical content: For the quality evaluation of qRT-PCR detection kits for the novel coronavirus (SARS-CoV-2), the reference materials used should be SARS-CoV-2 positive reference materials measured by standard methods or clinical samples verified by other methods. The measurement instruments used for quality evaluation should be calibrated and qualified measurement instruments. The evaluation indicators of qRT-PCR detection kits for the novel coronavirus (SARS-CoV-2) include RNA extraction and purification, detection limit, precision, specificity, reference material verification, stability, reagent storage and usage requirements, labeling and instruction requirements of the kits, waste disposal, and measures to prevent cross-contamination, etc.