Lentivirus Physical Titer qPCR Detection Kit _ 41333ES

YeasenSku: 41333ES50

Size: 50 T
Precio:
Precio de venta$1,485.00

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Descripción

The Lentivirus Physical Titer qPCR Detection Kit is a kit designed to quantitatively detect the physical titer of lentivirus (total number of viral particles) using the conserved region (LTR) in the genome of HIV-1-derived lentiviral vectors as a target.

This kit adopts the principle of fluorescence quantitative PCR by probe method to rapidly and specifically detect lentivirus RNA. The widest linear range can reach 5 copies/μL~5×108 copies/μL, with a detection limit as low as 0.5 copies/μL. And it contains the Lentivirus RNA Control (RNA quantitative reference product). The kit needs to be used together with the the Residual DNA Sample Preparation Kit (Cat# 18461ES) and Recombinant DNase I (RNase-free) (Cat#10325ES).

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 5 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 Lentivirus RNA 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 Lentivirus RNA test in biological products.

Specifications

Sensitivity

5 copies/uL (range 55×108copies/μL)

Assay Time

~1.5 hours

Assay Principle

Fluorescent probe qPCR method

Required Instruments

Real-time fluorescence quantitative PCR system

Product Performance

Product Performance Validation Program

Reference standards or requirements

YEASEN

1. Standards for the kit

Homemade standards are available

Plasmid RNA containing the conserved region (LTR) in the genome of HIV-1-derived lentiviral vectors

2. Linear Range

Assay Range

Refer to the actual situation

5~5x108 copies/μL

R2

≥0.98

≥0.99 and above

Slope

-3.1~-3.8

-3.1~-3.6

Amplification Efficiency

84%~109%

90%~109%

3. Accuracy

Recovery Rate

50%~150%

70%~130% and above

4. Precision

Repeatability

CV≤15%

10%

Intermediate precision

CV≤15%

15%

5. Exclusivity

No interference with RNA from other sources

Specific detection of Lentivirus RNA without interference from other exogenous RNA

6. Sensitivity

Limit of quantification

Reliable quantification of the smallest concentrations of target substances

5 copies/μL

Limit of detection

Refer to the actual situation

0.5 copies/μL

7. Durability

Reagent Stability

Evaluating the effect of different storage temperatures on reagent performance

37°C for 7 days, and repeated freeze-thaw 10 times, the kit amplification efficiency is in the range of 90%~109%, R2≥0.99 and above

Instrument Compatibility

Kits are used on different devices without affecting the test results

Compatible with many types of qPCR Instruments (eg. Bio-Rad CFX96 Optic Module, Thermo Scientific ABI 7500, ABI Quant Studio 5)

Components

Components No.

Name

41333ES50

41333ES60

41333-A

Lentivirus qPCR Mix

0.75 mL

1.5 mL

41333-B

One Step Enzyme Mix

200 μL

400 μL

41333-C

RNA Dilution Buffer

1.8 mL×2

1.8 mL×4

41333-D

Lentivirus RNA Control (5×108 copies/μL)

25 μL

50 μL

41333-E

IC*

50 μL

100 μL

*ICInternal control.

Storage

This product should be stored at -25~-15℃ for 1 years.

The 41333-A should be stored protected from light.

Figures

  •  Limit of quantification

Lentivirus RNA at concentrations of 10 copies/uL, 5 copies/uL and 2 copies/uL were detected, with 10 replicates for each concentration, respectively. The results showed that the CV of Lentivirus RNA was <20% at concentrations of 5 copies/μL and above. Therefore, the limit of quantification in the Lentivirus RNA detection kits was 5 copies/μL for Lentivirus RNA.

 Table 1. Limit of quantification (LOQ) assay results for Lentivirus RNA

 

 

Repetition number

 

Test item

Lentivirus RNA (copies/μL)

Quantity

Return ratio

1

5.43

108.60%

2

5.7

114.00%

3

4.93

98.60%

4

5.72

114.40%

5

4.76

95.20%

6

5.53

110.60%

7

6.53

130.60%

8

4.95

99.00%

9

4.84

96.80%

10

5.67

113.40%

Average value

5.41

\

CV

13.49%

\

Figure 1. 5 copies/μL Lentivirus RNA qPCR assay results

Figure 1. 5 copies/μL Lentivirus RNA qPCR assay results

  • Limit of detection

The detection of Lentivirus RNA 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 0.5 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 Lentivirus Physical Titer qPCR Detection Kit can reach 0.5 copies/μL.

Table 2. Limit of detection (LOD) assay results for Lentivirus RNA

 

 

Ct value

Theoretical concentration

Lentivirus RNA (copies/μL)

1

0.5

0.2

Positive count / Total count

20/20

20/20

18/20

Detection rate

100%

100%

90%

 

 

 

 

 

 

 

Documents:

Safety Data Sheet

41333_MSDS_HB250310.pdf

Manuals

41333_Manual_Ver.EN20250310.pdf

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