COVID-19 Coronavirus Real Time PCR Kit

COVID-19 Coronavirus Real Time PCR Kit
COVID-19 Coronavirus Real Time PCR Kit

Principle: Fluorescence real-time quantitative PCR

Automation: Yes

Approvals: NMPA, CE, FDA-EUA, WHO-EUL, ANVISA, TGA

Suitability: COVID-19 Coronavirus Real-Time PCR Kit is an In Vitro Diagnostic (IVD) reagent applying fluorescent PCR technology and aiming to qualitatively detect Open Reading Frame gene region (ORF1a/b) and viral nucleocapsid region (N) of SARS-CoV-2 RNA fr

Capital equipment required: Real-time PCR thermal cycler: Applied Biosystems 7500 (software version V2.3 and V2.4), QuantStudio™ 5 (software version V1.4.3 and V1.5.1), Roche LightCycler®480 (software version V1.5.1.62), Bio-Rad CFX96™ (software version V3.1), Shangh

Description:

COVID-19 Coronavirus Real-Time PCR Kit is an In Vitro Diagnostic (IVD) reagent applying fluorescent PCR technology and aiming to qualitatively detect Open Reading Frame gene region (ORF1a/b) and viral nucleocapsid region (N) of SARS-CoV-2 RNA from upper and lower respiratory tract specimens. 

Suitability: Upper respiratory tract specimens include throat swab and nasopharyngeal swab. Lower respiratory tract specimens include sputum. The product is intended for use on populations suspected to have SARS-CoV-2 infection as an aid in the diagnosis of SARS-CoV-2 infection by trained laboratory personnel on RT-PCR.


Key Points:
  • Target region: ORF1a/b and N genes
  • Clinical Sensitivity: 94.9%
  • Clinical Specificity: 98.7%
  • Limit of detection: 350 copies/mL
  • Sample input volume: 5μL
  • Sample type: Nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal aspirates, nasal washes, bronchoalveolar lavage (BAL) fluid and sputum specimens.
Company contact details:

Jiangsu Bioperfectus Technologies Co., Ltd. view full details
China Medical City
Taizhou
China

Website: Visit Website
Tel: +86 021-64193032