The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main symptoms include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.
The shelf life of this kit is 9 months when stored in freezer at -(20±5) ℃.
1. The limit detection of the kit is 500 copies.mL-1.
2. Coincidence rate of enterprise references: Coincidence rate of 12 negative references is 12/12, of 5 positive references is 5/5.
3. Precision: The coefficient of variation of Ct values of precision references is not higher than 5% within-batch and not higher than 10% inter-batch.
4. According to the results of clinical trial with 656 nucleic acid specimens from throat swab and sputum, the sensitivity and specificity of this kit are both higher than 98%.
The target region of ORF1 ab was highly conserved in novel Coronavirus, with low nucleotide diversity and highly specificity, considered as the key diagnostic target of novel Coronavirus infection;
At the same time, E and N genes were selected as auxiliary screening targets to meet the screening requirements of suspected patients, avoid missed diagnosis or misdiagnosis.
3-in-1 test: A single reaction for simultaneous detection of ORFlab gene, N gene, and E gene, hence preventing missed diagnosis and misdiagnosis.
Humanized internal standard: Entire process from sampling to testing is monitored to avoid
false negatives.
Twofold quality control approach: dUTP/UDG enzyme-based anti-contamination system, as
well as positive and negative controls.
Highly efficient testing: Simultaneous testing of 93 samples in 2 hours.
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