Phone : 86-523-86201352 Fax : 86-523-86816890 Email: [email protected] [jyo Instruction for use Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing) 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.cwbiosciences. com E-mail: [email protected] 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: [email protected] Version: A/5 Effective Date: 2021-01-06 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- CoWin Biotech CoWin Biotech

Principle Highly conserved region containing ORFlab and N gene in the novel coronavirus (SARS-CoV-2) genome is used to design specific primers and probes in this kit. Based on the fluorescence quantitative PCR platform, the principle of one-step fluorescence quantitative reverse transcription PCR was used to qualitatively detect the novel coronavirus (SARS-CoV-2). PCR detection system uses Human ACTB gene to design primers and probes as internal control, which can monitor the quality of respiratory nucleic acid and whole PCR reaction system. It avoids the risk of blank samples and false negatives....

Limitations of Test Methods Instrument Compatibility 1. The test results are only for clinical reference and shall not be the only standard for diagnosis. 2. The negative results can be caused by improper storage conditions of samples, Sample Requirements inhibitions in the samples and degradation of nucleic acids. The applicable samples are swabs. 3. Inappropriate sample collection, transfer and treatment, improper experimental operation and experimental conditions may lead to false negatives or false positives. 4. This product is only limited to the specified sample type and applicable instrument...

Table 1 Reaction Procedure 1. SARS-CoV-2 Positive Control: FAM and ROX channels have typical S-type amplification curve and CT value < 35. The internal control VIC channel has typical S-type amplification curve and CT value < 35. 2. SARS-CoV-2 Negative Control: FAM and ROX channel value CT > 40 or no CT value, the amplification curve is straight line or slight oblique line, no exponential growth period. The internal control VIC channel has typical S-type amplification curve and CT value < 35. 3. Experimental sample: the internal control VIC channel has a typical S-type amplification curve. 4....