Adeno-associated virus (AAV) is a widely used gene therapy vector and belongs to the adeno-associated virus family. Recombinant AAV (rAAV) is a genetically modified vector based on wild-type AAV. Replication-competent AAV (rcAAV) occurs through non-homologous recombination during the production of rAAV vectors, forming AAVs with replication capability, namely rcAAV. The China National Medical Products Administration indicates the need for quality control of rcAAV in gene therapy products. This reagent kit adopts PCR-fluorescent probe method, containing two systems for detecting rcAAV and rAAV respectively. The kit enables rapid, sensitive, and specific quantitative detection of both rcAAV and rAAV simultaneously. When used in conjunction with Biori's nucleic acid extraction or purification reagent kit, rcAAV can be quantitatively detected in as fast as 1.5 hours, down to a minimum of 2 copies/μL.
* The kit has undergone comprehensive method validation in accordance with relevant regulations and guidelines, with performance validation reports available.
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BP-QN28-100 说明书
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