Novel Coronavirus (2019-nCoV) Nucleic Acid Test Kit (Multiplex Fluorescence Kit)
Generic name: Covid-19（SARS-CoV-2）Nucleic Acid Test Kit
Package Specifications: 20 tests/kit；50tests/kit; 100 tests/kit
Intended Use:
The kit is used for the in vitro detection of suspected cases and suspected clustered cases of 2019-nCoV, as well as 2019-nCoV nucleic acid in oropharyngeal swabs, nasopharyngeal swabs or sputum specimens of other patients who need to go through infection diagnosis or differential diagnosis of 2019-nCoV, and it is for the auxiliary diagnosis of 2019-nCoV.
Fast:
- Optimised reaction system, greatly shortening PCR amplification time.
Convenient:
- Pre-mixed reaction solution, simpler operation
- Multiplex Fluorescent Quantitative PCR.
Good Performance:
- Limit of detection: 500 copies/ml.
- The coefficient of variation (CV,%) of the precision Ct value within the batch less than or equivalent 0.5%
- Clinical Accuracy: 95.03%, 95% confidence interval: 93.30% – 96.77%
Reliable:
- ORF1ab gene and N gene dual-site detection.
- Using the human housekeeping gene as an internal standard to effectively prevent false negatives.
- UNG enzyme + d UTP system to prevent false positives caused by aerosol pollution.
Professional Use Only
- The Kit is used for the in vitro detection of suspected cases and suspected clustered cases of 2019- nCoV, as well as 2019- nCoV nucleic acid in oropharyngeal swabs, nasopharyngeal swabs or sputum specimens of other patients who need to go through infection diagnosis or differential diagnosis of 2019 – nCoV, and it is for the auxiliary diagnosis of 2019-nCoV.
- COVID-19 SARS-CoV-2 Nucleic Acid Test Kit is a real-time RT-PCR test kit, intended for the qualitative detection of nucleic acid from the SARS-CoV-2, in upper and lower respiratory tract specimens (such as oropharyngeal swabs, nasopharyngeal swabs and sputum).
Performance Evidence:
Negative coincidence rate:100%, Positive coincidence rate:100%, Limit of detection:10³copies/ml,
Precision: CT variable coefficient (CV%)≦5%
Ideal time to take test for most accurate result (days post symptoms?): 0-14days
Analytical specificity: No cross reactivity with other coronaviruses 93.3-96.77%
Clinical sensitivity: 93.3-96.77%
Sample type: Nasopharyngeal or Oropharyngeal swabs
Testing Process:
