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Product Catalog

RCL Gene Copy Number Detection Kit (qPCR) is a 100-reaction BIORI qPCR kit for quantitative detection of replication-competent lentivirus in cell and gene therapy products. It targets the VSV-G gene using probe-based qPCR chemistry. Ready-to-use calibrators and an internal control support RCL copy-number testing in lentiviral-vector safety workflows.

RCL Gene Copy Number Detection Kit (qPCR), BP-QN10

USD

$0.00

BP-QN10-100

Size

- 100T - $1980.00

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Product information published by Zhuhai Biori Biotechnology Co., Ltd.

Features

Designed for quantitative detection of replication-competent lentivirus (RCL).
Targets the VSV-G gene using probe-based qPCR chemistry.
Uses ready-to-use calibrators prepared by serial dilution after digital PCR quantification.
Includes an internal control to monitor extraction and amplification abnormalities.
Contains UDG to help prevent carryover contamination from amplification products.
Supplied for 100 qPCR reactions in a kit format.
Supports RCL copy-number assessment in products produced with lentiviral-vector systems.

Application

RCL copy-number detection in cell therapy products.
RCL testing in gene therapy products produced by lentiviral vectors.
Vector safety and quality analysis workflows.
In-process or release-support testing for lentiviral-vector product development.
qPCR workflows using supported real-time PCR instruments.

Components

Component	Specification
RCL qPCR MIX 1	0.9 mL x 2 tubes
RCL qPCR MIX 2	0.2 mL x 1 tube
RCL Negative Control	1.0 mL x 2 tubes
RCL Calibrator ST1	0.5 mL x 1 tube; 1 x 10^1 copies/uL
RCL Calibrator ST2	0.5 mL x 1 tube; 1 x 10^2 copies/uL
RCL Calibrator ST3	0.5 mL x 1 tube; 1 x 10^3 copies/uL
RCL Calibrator ST4	0.5 mL x 1 tube; 1 x 10^4 copies/uL
RCL Calibrator ST5	0.5 mL x 1 tube; 1 x 10^5 copies/uL
RCL Calibrator ST6	0.5 mL x 1 tube; 1 x 10^6 copies/uL

Shipping and Storage

Condition	Recommendation
Storage	Store protected from light at <= -20°C. Validity period: 24 months.
Shipping	Ship frozen or under validated cold-chain conditions that maintain frozen storage.
Handling	Avoid repeated freeze-thaw cycles; do not exceed 10 freeze-thaw cycles.

Data

Performance Data

RCL Gene Copy Number Detection Kit (qPCR) | Catalog No. BP-QN10-100

A product-specific validation study evaluated analytical sensitivity, quantitation, linearity, and recovery for the RCL Gene Copy Number Detection Kit. The selected data below focus on results that are most useful for product evaluation.

Key Performance at a Glance

Selected performance summary for BP-QN10-100
Performance parameter	Selected result
Limit of detection	0.15 copies/μL
Limit of quantitation	1.5 copies/μL
Linear range	1.5 to 7.00E+06 copies/μL
Linearity and amplification criteria	R² > 0.99; amplification efficiency 90%–110%
Recovery	80%–120% acceptance range

Analytical Sensitivity

Observed in this validation study: all 24 replicates were detected at each evaluated concentration from 1 copy/μL down to 0.15 copies/μL.

Detection at evaluated low concentrations (source Table 1)
Sample concentration	Detection rate
1 copy/μL	24/24
0.5 copies/μL	24/24
0.2 copies/μL	24/24
0.15 copies/μL	24/24

Linearity

Observed in this validation study: the linear range was 1.5 to 7.00E+06 copies/μL, with R² = 0.99975 and amplification efficiency of 100.142%.

Linearity-series results (source Table 5)
Target (copies/μL)	Replicate 1	Replicate 2	Replicate 3	Mean	CV
1.50E+00	1.76E+00	1.20E+00	1.45E+00	1.47E+00	19.29%
1.00E+01	9.26E+00	9.85E+00	8.89E+00	9.33E+00	5.19%
1.00E+02	1.00E+02	1.00E+02	9.18E+01	9.74E+01	5.00%
1.00E+03	1.04E+03	1.03E+03	9.81E+02	1.02E+03	3.20%
1.00E+04	9.61E+03	9.59E+03	1.01E+04	9.77E+03	3.07%
1.00E+05	9.76E+04	9.27E+04	9.11E+04	9.38E+04	3.61%
1.00E+06	9.54E+05	8.80E+05	9.32E+05	9.22E+05	4.12%
7.00E+06	4.81E+06	4.74E+06	4.77E+06	4.77E+06	0.77%

Standard curve showing Ct versus log concentration for the BP-QN10-100 RCL assay; observed R² 0.99975 and amplification efficiency 100.142% in this validation study. — Linearity plot for the RCL assay across 1.5 to 7.00E+06 copies/μL (source report, Figure 1).

Recovery

Recovery was evaluated with automated and manual extraction workflows. Observed in this validation study: values in the selected table ranged from 94% to 117%.

Recovery with automated and manual extraction (source Table 15)
Extraction method	Sample	Replicate 1	Replicate 2	Replicate 3	Mean concentration	Recovery
Automated extraction	ERC-ST2	9.96E+00	8.71E+00	1.21E+01	1.03E+01	103%
	ERC-ST3	1.18E+02	9.01E+01	1.13E+02	1.07E+02	107%
	ERC-ST4	1.11E+03	1.13E+03	1.13E+03	1.12E+03	112%
	ERC-ST5	1.17E+04	1.09E+04	1.04E+04	1.10E+04	110%
	ERC-ST6	1.18E+05	1.21E+05	1.12E+05	1.17E+05	117%
Manual extraction	ERC-ST2	8.62E+00	9.53E+00	9.95E+00	9.37E+00	94%
	ERC-ST3	1.05E+02	1.04E+02	1.09E+02	1.06E+02	106%
	ERC-ST4	1.09E+03	1.12E+03	1.08E+03	1.10E+03	110%
	ERC-ST5	1.06E+04	1.12E+04	1.05E+04	1.08E+04	108%
	ERC-ST6	1.10E+05	1.19E+05	1.12E+05	1.14E+05	114%

Study Scope and Limitations

Results apply to the reference materials, extraction workflows, instruments, and acceptance criteria used in this product-specific validation study. Users should verify suitability with their own sample matrix and workflow.

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