RT-PCR Testing Kits

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

  1. 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.
  2. 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: