RCL Gene Copy Number Assay Kit [HYV006]

Type: qPCR
Product Code: HYV006
Specification: 100 tests/kit
Quantification Range:10⁶ copies/μL-10¹ copies/μL

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Product Introduction

Product Overview

Lentiviral vectors are currently widely used in clinical applications. They can be directly utilized as vector products for human use or can mediate the transfer and expression of target genes in target cells (such as T cells, NK cells, stem cells, etc.) to prepare ex vivo genetically modified cells for human administration. During the virus packaging process, replication-competent lentiviruses (RCL) may be generated due to mechanisms such as homologous or non-homologous recombination. From the perspectives of safety, efficacy, and quality control, such viruses should be tested to prevent uncontrolled self-replication in the human body, which could cause harm and avoid potential clinical safety incidents.

The RCL Gene Copy Number Assay Kit employs a fluorescence probe method to detect specific VSV-G sequences of lentiviruses. It enables rapid and accurate quantification of whether replication-competent lentiviruses are present in samples. The limit of detection can reach 3 copies/μL.

Product Performance

Validation Parameters		Validation Results
Linearity Range	Quantification Range	10⁶ copies/μL-10¹ copies/μL
	R^²	≥0.99
	Amplification efficiency	90%-110%
Accuracy	Spiked recovery rate	70%-130%
Precision	Intermediate precision	CV ≤ 20%
Precision	Repeatability	CV ≤ 20%
Recovery rate	Simulated sample recovery rate	70%-130%
Specificity		Specifically detects representative test samples; non-representative test samples (FBS, HEK293, C8166, and 1640 medium) test negative.
Stability		1) After 5 freeze-thaw cycles, kit performance remains unaffected. 2) Kit performance remains unchanged after storage at 4°C for over one month.

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Reverse Transcriptase Activity Assay Kit(RT-PCR Fluorescent Probe Method)	HYA001
Lentivirus Titer (HIV-1 p24) ELISA Kit	HYV002
RCR Gene Copy Number Assay Kit(PCR-Fluorescence Probe)	HYV007

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