Lyophilized Sars-CoV-2 (ORF1ab, N Gene Detection Kit (Real-time RT-PCR)

Cat. No.: UP-RS2G2-50L

[INTENDED USE]

Ultrassay Sars-CoV-2 detection kit is intended to in vitro qualitatively detect the ORF1ab and N genes of novel coronavirus (SARS-CoV-2) in the throat swab，nasal swab and sputum samples collected from cases and clustered cases suspected with novel coronavirus-infected pneumonia and others required for the diagnosis or differential diagnosis of novel coronavirus infection.

This product is mainly used for the auxiliary diagnosis of related cases during the novel coronavirus (SARS-CoV-2)-infected pneumonia epidemic since December 2019. The use of this product should comply with the relevant requirements of the Diagnosis and Treatment Protocol for Novel Coronavirus-Infected Pneumonia and the Prevention and Control Protocol for Novel Coronavirus-Infected Pneumonia.For the definitions of “cases suspected” and “clustered cases suspected”, please refer to the Diagnosis and Treatment Protocol for Novel Coronavirus-Infected Pneumonia, the Monitoring Protocol of Cases of Novel Coronavirus-Infected Pneumonia and other documents (current version) promulgated by China CDC.

The novel coronavirus nucleic acid detection should be carried out in accordance with the requirements of the China CDC Guidelines for Laboratory Testing Technology of Novel Coronavirus Pneumonia and a good job of bio-safety should be done.

[TEST PRINCIPLE]

This kit uses a combination of RT-PCR amplification and fluorescent probes to design specific primer probes for fluorescent detection in the highly conserved region of the “2019-nCoV” and internal reference genes. The 2019-nCoV ORF1ab gene probe labels FAM fluorophore, N gene probe labels CY5 fluorophore, internal reference probe labels VIC/HEX fluorophore, and the 3’end of the probe labels quencher. During the PCR amplification process, specific primers and probes are combined with the target sequence, and through the DNA polymerase activity of Taq enzyme and the 5’-3’ exonuclease activity, the formation of PCR products and the accumulation of fluorescent signals are completely synchronized to realize the qualitative detection of 2019-nCoV nucleic acid.

[ACCEPTABLE SPECIMENS]

Nasopharyngeal swab, oropharyngeal swabs, bronchoalveolar lavage fluid, saliva, sputum or fecal

[APPLICABLE EQUIPMENT]

Applicable to Ultrassay XP96/Mini 16 Real time qPCR system, ABI 7500 Real-Time PCR thermocycles, Bio-Rad CFX 96.