PCR Platform

Digital PCR (dPCR) is an effective tool for biosafety testing. This technology involves dividing a PCR reaction system into a large number of tiny reaction units to form "single-molecule template" PCR amplification, achieving precise nucleic acid quantification. Applications span Adventitious agent detection, viral sample copy number detection, plasmid copy number detection and nucleic acid standard material calibration.

Compared to the real-time quantitative PCR (qPCR), dPCR has the following advantages:

1. Quantification: dPCR provides an accurate concentration value of the target sequence directly, without relying on reference samples, standard curves, or Ct values, enabling precise quantification.

2. Sensitivity, Specificity, and Accuracy: Digital PCR exhibits excellent precision and accuracy, making it suitable for detecting trace nucleic acid samples and identifying minor differences in expression levels.

3. Inhibitor Tolerance: Digital PCR is tolerant to inhibitors and can detect target nucleic acids in complex matrices.

Based on professional biosafety testing knowledge and advanced digital PCR technology platform, SHENTEK provides customers with the following services:

Adventitious Agent Detection

Biological products and raw materials can conduct rigorous safety testing using digital PCR (dPCR) to detect possible trace nucleic acid contaminants.

a. Detect and identify viral, bacterial, and mycoplasma contamination

b. Test raw materials, cell banks, virus banks, and media

c. Expedite investigation and remediation of biological contamination events

Gene Stability Test

dPCR can accurately quantify the copy number of the target gene for the genetic stability of biological products. It exhibits high tolerance to common PCR inhibitors present in samples such as SDS, EDTA, and Heparin, suitable for complex samples detection.

Standard Material Calibration

SHENTEK offers a complete dPCR calibration standard material methodology, serving as a new alternative to formal UV spectroscopy and qPCR, to meet customer solution demands in product development and staging tests.