On January 30, 2020, WHO declared that the outbreak of COVID-19 constituted a public health emergency of international concern (PHEIC) and initiated the Emergency Use List (EUL) of in vitro diagnostic reagents for the detection of SARS-CoV-2. As of March 24, 2020, the EUL applications for a total of 16 products had been accepted, all of which are in vitro diagnostic reagents based on nucleic acid detection. Among them, 10 products which had complete documentation were under formal EUL review, SARS-CoV-2 Virus Detection Diagnostic Kit (RT-qPCR Method) of Health Gene Technologies was included.
Meanwhile, SARS-CoV-2 Virus Detection Diagnostic Kit (RT-qPCR Method) has also been accepted by FDA for the application for emergency use authorization (EUA) with Acceptance No. Of PEUA200166.
This product has been issued CE certification from EU on March 8, 2020, and has been applied to the battle field against COVID-19 in Europe.
Adopting the One-Step Reverse Transcription Polymerase Chain Reaction (One-Step RT-PCR) in combination with the Taqman Probe Technology, this product is designed with specific primers and probes respectively against the highly conserved sequence areas of the ORF1Ab Gene, N Gene and S Gene to conduct a qualitative testing of SARS-CoV-2 RNA.
1. Three genes detection of ORF1Ab, N and S
The SARS-CoV-2 virus spreading rate is incredibly fast as well as its mutation rate. Detection of multiple gene targets can greatly reduce the false negative detection probability caused by virus mutation.
2. UDG-dUTP Contamination Resistant System
According to the Guidelines of National Medical Products Administration for Registration of Nucleic Acid Detection Technologies and the Recommendations of the US CDC, using UDG-dUTP System can effectively prevent PCR aerosol contamination, reduce the false positive incidence and ensure stable results under the circumstance of growing testing demand day by day.
3. Internal Quality Control
The internal quality control which is designed based on human RNA sequence is capable of effectively monitoring the sample RNA quality. The genome of SARS-CoV-2 is RNA in nature, which is prone to being degraded by endogenous RNase of the sample under improper storage and handling conditions causing false negative result. Internal quality control will provide an indication or warning against such a situation.