On January 30, 2020, the WHO announced that the outbreak of COVID-19 constituted a public health emergency of international concern (PHEIC). At the same time, the Emergency Use List (EUL) of in vitro diagnostic reagents for the detection of SARS-CoV-2 has been launched. As of March 24, 2020, a total of 16 products have been accepted for EUL applications, all of which are based on nucleic acid detection in vitro diagnostic reagents. Among them, 10 products, including SARS-CoV-2 Virus Detection Diagnostic Kit (RT- qPCR Method) from Ningbo Health Gene Technologies Co., Ltd., have been submitted with complete materials and officially entered the EUL review stage.
The SARS-CoV-2 Virus Detection Diagnostic Kit (RT- qPCR Method) has also been obtained by the FDA’s Emergency Use Authorization (EUA). The acceptance number is PEUA200166.
This product has obtained the European Union CE certification on March 8, 2020. It is now available for purchase in the European Union.
This kit uses one-step reverse transcription-polymerase chain reaction (One Step RT-PCR) method and Taqman probe technology to qualitatively detect SARS-CoV-2 RNA. Specific primers and probes were designed to target highly conserved regions of ORF1ab gene, N gene and S gene sequences.
1. Detection of three target genes ORF1ab, N and S
The transmission speed of SARS-CoV-2 is beyond imagination, and its mutation speed is also very fast. Detection of multiple gene targets can greatly reduce the probability of false negative detection due to virus mutation.
2. Anti-pollution system of UDG&dUTP
Guidelines for the registration of nucleic acid detection technology by the State Food and Drug Administration and the United States CDC suggest that the use of UDG enzymes and dUTP systems can effectively prevent PCR aerosol contamination and reduce the probability of false positives. While the amount of detection is increasing,
the reagents can still produce stable results
3. Endogenous control
Endogenous control based on human RNA sequence is designed, which can effectively monitor the RNA quality of specimens. The genome of SARS-CoV-2 is RNA. If the RNA is improperly stored, it can be easily degraded by RNase in the specimen, resulting in false negative results. The endogenous control can warn of this situation.
Ningbo HEALTH Gene Technologies Co. Ltd.
HEALTH Gene Technologies Co. Ltd. (HGT) which was established in August 2011 specializes in the research and development, manufacturing, distribution and services of nucleic acid (gene) analysis and molecular diagnostic products applications. Adhering the principle of “For Safer society and Healthier life”, HGT has been committed to research, developing and manufacturing world leading quality molecular diagnostic products for nucleic acid, which provided dependable solutions for personal identification, paternity testing, infectious pathogen detection and guidance for personalized medicine.
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