Gene Platform

PCR

Instrument Introduction

The QuantStudio®5 real-time fluorescence quantitative PCR system is a new product of the QuantStudio® system series. An advanced touch screen is used to make it easier for you to set up and run experiments. They are suitable for novice and experienced users. They are simple and cost-effective real-time fluorescence quantitative PCR systems, providing better performance and quality.

Obtain, analyze and share data anytime, anywhere-Use web browser-based software to remotely monitor your experimental operation, analyze complex data sets in a few minutes, and save the data in a safe space, share results safely online with colleagues across the child.

Obtain trusted results-Detect 1.5 times the copy number difference in a single analysis reaction to obtain a linear dynamic range of 10log.

Instrument Model

ABI QS5

Analysis Scenario

In addition to flow cytometry, which can monitor the expression of CAR-T cells in subsequent vivo, it can also be detected by fluorescence quantitative PCR. TaqMan real-time fluorescence quantitative PCR is usually used to detect CAR-T cells in peripheral blood or bone marrow to determine the survival and distribution of CAR-T cells in patients after reinfusion. The real-time fluorescence quantitative PCR method has the characteristics of high specificity. In the field of cell therapy, the screening of virulent strains, the degree of virus droplets, the average vector copy number of the product, and the survival of the patient’s CAR-T cells after reinfusion, replicative retrovirus residue, host DNA residue and mycoplasma detection are widely used.

The method of qPCR was used to detect the cell therapy product and its clinical sample L for RCL (replication virus). In the 2018, the “Key Points for Quality Control and Testing of CAR-T Cell Therapy Products and Non-clinical Research Considerations” issued by the China Institute for Food and Drug Administration clearly stipulates the necessity of RCL testing.

Our company establishes RCL detection method based on qPCR platform, with quantitative sensitivity up to 2 copies/μl and qualitative sensitivity up to 1 copies/μl. The target gene and the internal reference gene can react at the same time, and RCL results can be quantified to the number of copies per ng DNA according to customer requirements.

ddPCR

Instrument Introduction

Naica Crystal droplet digital PCR system adopts cutting-edge microfluidic innovative 2dsapphire chip as the design core of the whole system. Only PCR premixed liquid needs to be added to Sapphire chip to complete droplet generation, the whole process of amplification and analysis. Combining powerful image analysis and visual software analysis, excellent confidence level and true and reliable data results are obtained.

Instrument Model

Naica digital PCR system

Analysis Scenario

In the absolute quantification of nucleic acids, digital PCR technology, due to its extremely high sensitivity, fully compensates for the application fields that cannot achieve good resolution by relying on the ct value (Real Time PCR technology), for example, trace nucleic acid detection, rare mutation detection, copy number variation, single cell gene expression analysis, etc., and these test results are of great significance to medical research, especially in liquid biopsy (cfDNA), detection of infectious diseases, early diagnosis of cancer, prognosis and follow-up, and organ transplantation. The application of digital PCR in the field of cell therapy is also more and more extensive, including virus titer detection in CAR-T transfection system, average vector copy number detection, biological agent host cell residue detection, CAR-T PK detection, MRD detection, RCL/RCR monitoring detection, etc. The dPCR method does not require a standard curve to detect RCL, reducing human error and shortening the detection time.