Intended Use
This product is used for in vitro qualitative detection of 2019-nCoV, Influenza A virus, Influenza B virus, Respiratory syncytial virus (RSV), Human adenoviruses (HAdVs), Chlamydia pneumoniae (CP) and H1N1 influenza virus RNA in human throat swab.
Acute respiratory infection is a common and frequently occurring disease worldwide. Respiratory virus is an important pathogen of acute respiratory infection. Its clinical manifestations are mainly rhinitis, pharyngitis, laryngitis, Tonsillitis, and other symptoms. Severe cases can cause tracheitis, bronchitis, and pneumonia. It is the main cause of morbidity and mortality in winter and spring for young children, the elderly and the infirm, and those with low immune function. It has been proven that 80% of acute upper respiratory diseases and most lower respiratory diseases are caused by pathogens outside of bacteria, with respiratory viruses being the most common.
The test results are for clinical reference only and cannot be used to confirm or exclude cases alone.
Test Principle
This kit is based on real-time PCR fluorescence technology and designed specific primers and corresponding fluorescent probes for the conserved regions of the respiratory 2019-nCoV, FluA, FluB, RSV, ADV, CP, or H1N1 genome for highly specific detection. By detecting changes in fluorescence signals, 2019-nCoV, FluA, FluB, RSV, ADV, CP, or H1N1 nucleic acids can be qualitatively detected in throat swab samples.
This reaction system contains dUTP-UNG enzyme anti-pollution measures to avoid false positive results; an internal control is provided to avoid false negative results.
Technical Specifications
REF No. |
CFP003 |
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Regulatory Status |
CE IVD |
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Packing Specifications |
48 tests/kit, 96 tests/kit |
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Technology |
Real-time PCR |
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Type Of Analysis |
Qualitative |
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Sample Type |
Throat swab |
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Reaction Volume |
30μL |
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Detecting Target |
FluA, 2019-nCoV, FluB, ADV, RSV, CP, H1N1 |
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Analytical Sensitivity |
1000 copies/mL |
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Precision |
CV≤5% |
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Storage |
-20±5℃ in dark for 12 months 2~8℃ after opening the cover for 2 weeks |
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Validated Extraction Method |
General nucleic acid extraction kit (Singuway Ref No.: MTQ064/MTQ096) is recommended. |
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Instruments |
A real-time PCR instrument containing at least four colors fluorescence channels, Singu9600, Singu9600 Pro, AccuRa-32, AccuRa Mini, Bio-Rad CFX96, ABI 7500, Roche LightCycler 480.
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Required Detection Channels |
FAM, HEX, CY5, ROX |