Description
COVID-19 Coronavirus Real Time PCR Kit is an In Vitro Diagnostic (IVD) reagent applying on fluorescent PCR technology and aiming at 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.
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.
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Features
• Multiplex real-time PCR detects different targets specific for SARS-CoV-2
• Internal controls ensures the whole process is reliable
• Better performance makes the results more accurate
• More efficient: 96 samples in 72 minutes (on an instrument)
• Suitable for more mainstream instruments
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Specifications
• 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.
• Package: 50 Tests/Kit
• Certificates: NMPA, CE, FDA-EUA, WHO-EUL, Brazil ANVISA, TGA, Thai FDA etc.
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