Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit ( Real Time PCR)

Intended Use

2019-nCoV detection kit is an in vitro diagnostic medical device, intended for the qualitative detection of ORF 1ab and N Gene of SARS-CoV-2 RNA in throat swabs and sputum specimens. The function of the assay is for the diagnosis or aid fordiagnosis of COVID-19.

For the definitions of ’suspected cases‘ and ’suspected clustered cases‘, refer to the documents such as Novel Coronavirus Infected Pneumonia Diagnosis and Treatment Plan and Novel Coronavirus Infected Pneumonia Case Monitoring Plan issued by China CDC carried out.

This product is only used in the pneumonia epidemic of SARS-CoV-2 infection since December 2019. The auxiliary diagnos is of related cases and the in vitro diagnostic epidemic reserve of this epidemic cannot be used as clinical in vitro diagnostic reagents.

In use, the relevant requirements of the Pneumonitis Diagnosis and Treatment Scheme for Novel Coronavirus Infection and Pneumonitis Prevention and Control Scheme for N ovel Coronavirus Infection should be complied.

Test Principle

The assay is based on the real time polymerase chain reaction (PCR) technology and is composed of a ready to use optimized mixture with target specific primers and Taqman probes for the detection of SARS-CoV-2.

TaqMan probes consist of a fluorophore covalently attached to the 5′-end of the oligonucleotide probe and a quencher at the 3′-end. The quencher molecule quenchesthe fluorescence emitted by the fluorophore when excited by the cycler’s light source via FRET. As long as the fluorophore and the quenche r are in proximity, quenching inhibits any fluorescence signals.

Degradation of the probe releases the fluorophore from it and breaks the proximity to the quencher, thus relieving the quenching effect and allowing fluorescence of the fluorophore. Hence, fluorescence detected in the quantitative PCR thermal cycler is directly proportional to the fluorophore released and the amount of DNA template pres ent in the PCR.

Packing: 50 Tests

Origin: China

Certificate: CE