Rapid collection and testing of appropriate specimens from individuals meeting the suspect case definition for COVID-19 is a priority for clinical management and outbreak control and should be guided by a laboratory expert. Suspect cases should be screened for the virus with nucleic acid amplification tests (NAAT), such as RT-PCR.
Detection Kit for Novel Coronavirus (SARS-CoV-2) RNA (PCR-Fluorescence Probing) (the ‘Kit’) developed by GENETRON HEALTH aids in the detection and diagnosis of COVID-19 virus and is based on widely used nucleic acid amplification technology. It contains oligonucleotide primers and dual-labeled hybrolysis probes and control material used in RT-PCR for the in vitro qualitative detection of COVID-19 RNA in respiratory specimens. GENETRON HEALTH has completed the performance validation with Beijing CDC.
The kit is CE certified and FDA EUA-Authorized.
This product is used for the in vitro qualitative detection of SARS-CoV-2 ORF1ab gene, and N gene in bronchoalveolar lavage, sputum, and oropharyngeal swabs samples of novel coronavirus-infected suspected pneumonia cases, and others to be confirmed or identified with novel coronavirus infection, thus supporting clinical diagnosis.
Comprehensive and accurate: Simultaneous detection of the conserved regions of the ORF1 a / b gene and N gene of the new coronavirus, only when the positive results of these two genes can be diagnosed as new crown cases; the internal reference monitoring and detection process is introduced to reduce the false negative rate; High, minimum detection 10 copies
Anti-pollution system: dUTP and UDG enzyme are used together to further reduce the possibility of pollution
Simple and fast: one-step technique, manual operation for 10 min, full workflow 2.5 hr; suitable for rapid detection of large-scale samples
Product: Detection Kit for Novel Coronavirus （SARS-CoV-2）RNA (PCR-Fluorescence Probing)
Display name: ORF1 a/b and N gene conserved regions
Specimen Requirements: Bronchoalveolar lavage / Sputum / Oropharyngeal swabs
Instrumentation and Software: BIO-RAD: CFX96 Touch Real-Time PCR Detection SystemABI: 7500 Real-Time PCR System ／QuantStudio 3 and 5 Real-Time PCR Systems
Packing Specification: 50 Tests
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