IFU-CW3130M-NP
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Phone : 86-523-86201352 Fax : 86-523-86816890 Email: service@cwbiotech.com Manufacturer Jiangsu CoWin Biotech Co., Ltd Add: No.58 G52 Building, East of Lujia Road, West Side of Tai Road, China medical city, Taizhou, Jiangsu, 225300 Phone: 86-523-86201352 Fax: 86-523-86816890 Web: https://www.cwbio.com E-mail: service@cwbiotech.com EC-Representative SUNGO Europe B.V. VAT: NL857821659B01 Add: Olympisch Stadion 24, 1076DE Amsterdam, Netherlands Contact: SUNGO Secretary Tel /Fax: +31 (0) 2021 11106 E-mail: ec.rep@sungogroup.com Version: A/6 Effective Date: 2021-06-10 Product: Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing) Size: 48 tests/Box/96 tests/Box Applications The Novel Coronavirus (SARS-CoV-2) FAST Nucleic Acid Detection Kit is developed for qualitative detection of SARS-CoV-2 that is collected from human oropharyngeal swabs in vitro. The applicable population includes: suspected cases of Novel Coronavirus (SARS-CoV-2) infected pneumonia, suspected aggregated cases, and other patients who need to be diagnosed or differentiated with Novel Coronavirus (SARS-CoV-2) infection. The novel coronaviruses belong to the p genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. The novel coronavirus detection should meet the requirements of "new laboratory technology related to new coronavirus pneumonia detection guidelines" and address biosafety issues. -1- www.cwbio.com CoWin Biotech CoWin Biotech

4. The sample should be completely added into the reaction solution. After adding the Highly conserved region containing ORF1ab and N gene in the novel coronavirus sample, cover the tube lid as soon as possible and spin the tube. (SARS-CoV-2) genome is used to design specific primers and probes in this kit. Based 5. After amplification, take out the reaction tubes, seal them in a special plastic bag, on the fluorescence quantitative PCR platform, the principle of one-step fluorescence and discard it in a designated place. quantitative reverse transcription PCR was used to qualitatively...

Instrument Compatibility Limitations of Test Methods 1. The test results are only for clinical reference and shall not be the only standard for ABI 7500，Bio-rad CFX 96, Tianlong Gentier 96, Lepgen 96, MA-6000. Sample Requirements 2. The negative results can be caused by improper storage conditions of samples, Saliva, sputum, tracheal, aspirate or bronchoalveolar lavage, nasopharyngeal aspirate, nasopharyngeal and pharyngeal swabs, blood urine and stool. inhibitions in the samples and degradation of nucleic acids. 3. Inappropriate sample collection, transfer and treatment, improper...

Positive control and negative control