Introduction of blood screening NAT system

Screening blood fluorescence NAT system developed by DaAn Gene Co., Ltd. Of Sun Yat-sen University, Including three kinds of PCR kits contained high sensitivity fluorescence gene probe: HBV, HCV and HIV , owning corresponding Chinese and Hongkong patent. DaAn Gene firstly developed fluorescent PCR gene probe technique and reagent in the domestic, and the quality reaches the international level. HBV and HCV kit was both conferred the national Category II new drug certificatethe issued by State Drug Administration (SDA) in 1999 and 2000, in which HBV kit is the first fluorescence PCR kit to be awarded new drug certificate in the world. In 2010, HBV, HCV and HIV-1 virus nucleic acid detection kit for blood screening(PCR- fluorescent probe method) are  granted the new drug certificate.
DaAn fluorescence NAT system uses magnetic beads extraction system and high sensitive fluorescence gene probe PCR system. In automatic real-time fluorescent gene probe PCR instrument, automatic amplification, detection and sensitivity reached the international advanced level. It is suitable for pooling detecting in blood samples which is more economic and reasonable scheme. Samples can be serum or plasma.

Quality assurance

Composed of the strict quality control system and the precision of production process. The company has passed GMP certification, ISO13485 certification and CE certification and owns long-term clinical PCR reagent production experience. A perfect quality management system strictly monitors the whole process of production.

The characteristics of DaAn Gene triple PCR detection reagent 

1. HBV/HCV/HIV amplified triply and independently
A sample extraction is amplified with three tubes, can avoid the influence of the sensitivity by mixed infected samples, and save the cost of reagent split and review.
2. Completely independent amplification system (hot-start enzyme; reverse transcriptase one-step system)
10 years of clinical validation. Guaranteeing the specificity of primers design and effectiveness of preventive measures of gene mutation .
3. RNA internal standard quality control system of false virus (MSII vector construction)
Monitor the whole process from the extraction to the amplification results, avoiding the occurrence of false negative detection.
4. Anti-pollution system
Automatic loading system to pack reagent, avoiding loading errors caused by manual package.
Fully closed tube detection analysis, avoiding aerosol pollution of the product caused by opening tube cover.
Anti-pollution system of UNG enzyme, avoiding cross contamination caused by amplifying nucleic acid.
5. Using the 2.4ml sample, guaranteeing the efficient stable of PCR reaction system and the sensitivity of stability

The property of DaAn Gene triple PCR detection reagent

Sensitivity（12Pooling，2.4mL, 2010)

Coverage range

Constructive requirement of nucleic acid detection lab

Laboratory design refers to inspection center of healthclinical Ministry "management measures of clinical gene amplification laboratory ". The working area is divided into the preparation area of the reagent , sample processing district, amplification and analysis area and quality control laboratory.
1. Members flow single direction, the independent district.
2. Reagent preparation area is responsible for storing and liquid configuration, sample processing region for specimen extraction, amplification and analysis areas for the amplification and the analysis of result, quality control laboratory for quality control of the whole process of experiment, guarantee that the results are accurate.

Equipment and personnel of  nucleic acid detection laboratory

• To ensure that a blood NAT detection is effective to carry out, planning of required equipment and personnel.
• Automatic nucleic acid extraction instrument (ChemagicSTAR) 1
• Fluorescent real-time PCR (ABI7500) 1
  • 2 operators (operators, quality control administrator, the administrator)