The KHB total solution of NAT for blood screening is composed by six modules:
1. Sample processing module
Cooperating with Hamilton, an internationally renowned manufacturer of automated liquid handling workstations, to create a fully automated nucleic acid extraction and purification platform based on Microlab Star platform. On this platform, the system can automatically complete sample collection, nucleic acid extraction and purification, PCR reaction solution and nucleic acid template loading; pool sample and single-part (split) samples can be operated simultaneously in this system; the system has a 96-well sample module, and the maximum sample throughput of each batch reaches 2256 samples (24 pooling mode).
2. Nucleic acid detection module
The system adopts ABI 7500 real-time fluorescence quantitative PCR automatic analysis system of Thermo Fisher Scientific in the United States. The system adopts real-time pcr through a fluorescent probe, which is the international mainstream nucleic acid detection technology. After the amplification test, the detection results of each virus item are directly analyzed without additional identification. In addition, 96 tests are completed at per batch.
3. Information Management Module
The system can automate data management for the information management system of nucleic acid screening for blood stations and blood products enterprises. The system can manage all data and instrument operation processes, and effectively integrate the sample information, collection information and test results of barcode scanning records, ensuring the reliability and traceability of all sample test results.
4. The Reagent Module
The reagents used in the KHB system of screening nucleic acids in the blood include “Diagnostic kit for Hepatitis B Virus, Hepatitis C Virus, and Human Immunodeficiency Virus (Type 1) (PCR-Fluorescence Probing) and the kits received the national SFDA registration certificate in 2010. The system adopted the 24 collection model to balance cost and performance. It is the only reagent in China that has been approved by the state for the detection of nucleic acids in routine samples of blood products enterprises, which can be used to determine HBV DNA, HCV RNA and HIV-1 RNA in serum or plasma samples.
5. Special supporting supplies
The special consumables used by KHB Nucleic Acid Screening System are all imported products supplied by the instrument manufacturer. All is treated by sterilization and DNase and RNase removal process to ensure the accuracy and reliability of the experimental results.
6. Standard operating procedure
KHB has the longest practical experience of serving domestic users of blood station and blood products enterprises. And it has developed the systematic standard operating procedure (sop) about operation, maintenance, laboratory workflow, management, etc., to ensure the user's process of stability and reliability and compliance.
