The Replication-competent Retrovirus (RCR) Detection Kit can be used to quantitatively analyze and detect the potential risk of Replication-competent Retrovirus (RCR) that may occur in a variety of cellular therapeutic products and gene therapy products associated with the use of retrovirus vectors.

This kit targets specific sequences on the retroviral vector to design specific primers, and adopts the principle of fluorescence quantitative PCR by probe method to rapidly and specifically detect the risk of replicative retrovirus (RCR). And the limit of quantification can be as low as 10 copies/μL, the limit of detection can be 0.3 copies/μL, it contains the RCR DNA Control (DNA quantitative reference product). The kit needs to be used together with the the Residual DNA Sample Preparation Kit (Cat# 18461ES).

Features

• Compliance with regulations: the products are fully validated according to the requirements of Chp, USP, ICH, etc., and their performance is in line with Chinese and foreign regulations and standards;
• Guarantee of quality: the raw materials of the kits are all self-developed, and the qPCR Mix and other enzyme products are produced in an ultra-clean enzyme factory;
• High sensitivity: the lower limit of quantification (LLOQ) was 10 copies/uL;
• High precision: high intra-batch reproducibility CV <10%, small inter-batch variation i.e. intermediate precision CV <15%;
• Strong specificity: specific detection of RCR residual DNA without interference from other exogenous genomic DNA;
• Strong anti-interference: the introduction of internal quality control (IC) can exclude sample interference, abnormal reaction preparation and other factors, effectively avoiding false negatives.

Application

• Residual RCR DNA test in biological products.

Specifications

Product Performance

Components

*IC：Internal control.

Storage

This product should be stored at -25~-15℃ for 2 years.

The 41329-A should be stored protected from light.

Figures

• Limit of quantification

RCR DNA at concentrations of 5×101 copies/uL, 30 copies/uL, 20 copies/μL, 10copies/μL and 5 copies/uL were detected, with 10 replicates for each concentration, respectively. The results showed that the CV of RCR DNA was <20% at concentrations of 10 copies/μL and above. Therefore, the limit of quantification in the RCR DNA residue detection kits was 10 copies/μL for RCR.

Table 1. Limit of quantification (LOQ) assay results for RCR DNA

Figure 1. 10 copies/μL RCR DNA qPCR assay results

•  Limit of detection

The detection of RCR DNA at various concentration points under the quantitative limit, combined with the blank limit requirements, yields the detection limit of the reagent kit. The results show that at concentrations of 0.3 copies/μL and above, in 20 repeated wells, ≥19 wells are detected (i.e., the detection rate is ≥95%). Therefore, the detection limit of the Replication-competent Retrovirus (RCR) Detection Kit can reach 0.3 copies/μL.

Table 2. Limit of detection (LOD) assay results forRCR DNA

Documents:

Safety Data Sheet

41329_MSDS_HB250310.pdf

Manuals

41329_Manual_Ver.EN20250310.pdf