RCR Gene Copy Number Assay Kit [HYV007]

Type: qPCR
Product Code: HYV007
Specification: 100 tests/kit
Quantification Range:10⁵ copies/μL-10¹ copies/μL

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Product Introduction

Product Overview

Cell and gene therapy products carry the risk of contamination by replication-competent viruses during the manufacturing process. For products produced using retroviruses, replication-competent virus testing is required.
The RCR Gene Copy Number Assay Kit utilizes a fluorescence probe RT-PCR method to detect specific sequences of the retrovirus RD114. It enables accurate, rapid, and specific quantification of replication-competent retrovirus (RCR) copy numbers in intermediates, semi-finished, and finished products of various biologics and pharmaceuticals. The limit of detection can reach 2.5 copies/μL.

Product Performance

Validation Parameters		Validation Results
Linearity Range	Quantification Range	10⁵ 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		Non-representative test samples (HEK293, FBS, DMEM) yield negative results; representative test samples yield positive results.
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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Lentivirus Titer (HIV-1 p24) ELISA Kit	HYV002
RCL Gene Copy Number Assay Kit(PCR-Fluorescence Probe)	HYV006

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