COVID-19 Coronavirus Real Time PCR Kit
Principle: Fluorescence real-time quantitative PCR
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 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 V22.214.171.124), Bio-Rad CFX96™ (software version V3.1)
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.
- 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.
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