[Intended use]

This kit is used for in vitro qualitative detection of Novel Coronavirus(2019-NCOV)ORFlab and N genes in throat swabs and disease fluid samples of suspected pneumonia cases,suspected clusters of suspected coronavirus cases, and other persons requiring diagnosis or differential diagnosis of Novel Coronavirus infection.The definition of"suspected cases","suspected clusters of cases" and other groups shall be based on the NovelCoronavirus Diagnosis and Treatment Protocol for Pneumonia Infection and Novel Coronavirus Case Surveillance Protocol for Pneumonia Infection(current version)issued by CDC of China.The product is used for nucleic acid testing of samples collected from novel Coronavirus(2019-NCOV) infected persons or suspected coronavirus infected persons as an adjunctive diagnostictool in 2019-NCOVinfected persons. In use, the relevant requirements of the Novel Coronavirus Pneumonia Diagnosis and Treatment Protocol and the Novel Coronavirus Pneumonia Prevention and Control Protocol shall be observed.Novel Coronavirus nucleic acid testing should be carried out in accordance with the TechnicalGuidelines for Laboratory Testing of COVID-19 in China and other requirements to ensure biosafety.

[Inspection Principle]This kit uses virus lysate to process the sample,which can lysate the virus to release nucleic acid and inhibit RNA enzyme activity. After the sample is mixed with virus lysate,the PCR reaction mixture can be directly added. The amplification principle of this kit adopts RNA reverse transcription and polymerase chain reaction(PCR)combined with TaqMan technology.Highly specific primers and TaqMan probes are designed according to the nucleic acid sequence of the conserved region of the virus.FCRamplification is performed under the action of reverse transcriptase/Taq enzyme exonucase activity to generate fluorescence signal Real-time amplification curve was obtained,and internal standard was used to control the quality of false negative and PCRinterference,so as to achieve accurate detection of 2019-NCOV nucleic acid.

Our products are detected by PCR, not antigens. And PCR is more sensitive than antigen. The test results are also relatively accurate, avoiding false positives and false negatives, and we have reduced the detection time to 15 minutes.Secondly, in order Our products are detected by PCR, not antigens.Secondly, in order to get the most accurate test results, our products are sold together with sample preservation solution. to get the most accurate test results, our products are sold together with sample preservation solution.