T/CQAP 2002-2022 in English

本文件规定了基于水泡性口炎病毒载体的新型冠状病毒核酸检测用阳性假病毒质控品（以下简称假病毒质控品）假病毒质控品原液和假病毒质控品成品的技术要求和试验方法。
本文件适用于研发机构、生产企业及临床医学检验与医疗单位开展针对水泡性口炎病毒载体新型冠状病毒核酸检测用阳性假病毒质控品的质量控制与性能评价。

Scope

Fluorescent PCR nucleic acid testing for the novel coronavirus (SARS-CoV-2) is a key supporting technology for clinical diagnosis of novel coronavirus infection in China and for conducting precise epidemic prevention and control measures. However, there are currently no standardized standards for positive quality control reagents to ensure the reliability and accuracy of test results.

Positive pseudo-virus quality control reagents based on Vesicular Stomatitis Virus (VSV) vectors for novel coronavirus nucleic acid testing belong to a class of standard materials used in fluorescent PCR detection quality control. These quality control reagents are non-replicating, non-pathogenic RNA pseudo-viral particles carrying fluorescence protein reporter genes. The sequences of the three target genes for SARS-CoV-2 nucleic acid testing (the full-length N gene of capsid protein and the full-length E gene of envelope protein and the ORFlab open reading frame) match those specified by the China Centers for Disease Control and Prevention or the World Health Organization (WHO). They are suitable for approved SARS-CoV-2 nucleic acid test kits, ensuring good interoperability with clinical samples.