RCL Gene Copy Number (qPCR) Detection Kit-Safety Detection-君研生物科技(山西)有限公司

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RCL Gene Copy Number (qPCR) Detection Kit

Item number：RCL0311A-100

Specs：100 Reactions

Sell-by date：12 months

Storage conditions：-20℃

Technical support：19503412257

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RCL Gene Copy Number (qPCR) Detection Kit

Product Introduction

Like retroviral vectors, RCL can integrate into the cellular genome, thereby posing a risk of secondary tumors induced by integration, which may activate proto-oncogenes, disrupt tumor suppressor genes, or increase the expression of cell growth-promoting factors. The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) newly issued the "Technical Guidelines for Pharmaceutical Research and Evaluation of In Vivo Gene Therapy Products (Trial)" and "Technical Guidelines for Pharmaceutical Research and Evaluation of In Vitro Gene-Modified Systems (Trial)" in May 2022, both of which mention that RCL detection, as a safety test, is crucial in the research and development as well as production of cell-based drugs.

Independently developed by Junyan Bio, the RCL Gene Copy Number (qPCR) Detection Kit is designed for the viral envelope protein VSV-G gene. It features strong specificity and high sensitivity, enabling rapid and specific quantitative detection of RCL in lentiviral vector-related cellular products. This kit can be used in conjunction with Junyan Bio's "Host Cell Residual DNA (Magnetic Bead Method) Sample Pretreatment Kit" and automatic nucleic acid extractors.

Performance Parameters

Standard Linear Range: The linear range of the kit's standard is 1×10⁶ copies/μL - 1×10¹ copies/μL, covering 6 concentrations. The linear correlation coefficient should meet R² ≥ 0.980, the amplification efficiency should be 90% ≤ Eff (%) ≤ 110%, and the CV of the detection value for each concentration should be < 15%.
Conformity Rate of Negative Reference: The NTC value is Undetermined or > 35.
Limit of Quantitation: After repeated determination of the 10 copies/μL reference standard for 10 times, the coefficient of variation (CV) should be ≤ 20%, and the measurement deviation should not exceed |±20%|.
Accuracy - Recovery Rate: When 100 μL samples are subjected to nucleic acid pretreatment using Junyan Bio's "Host Cell Residual DNA (Magnetic Bead Method) Sample Pretreatment Kit", followed by detection with the RCL Gene Copy Number (qPCR) Detection Kit, the recovery rate can reach 70% - 130%.