2019-nCoV Neucleic Acid Test Kit (PCR-fluorescence probe method)(Rapid PCR Solution)

Coincidence rate of positive reference products: 100%；Coincidence rate of negative reference products: 100%

the coefficient of variation of Ct value (CV, %) is less than or equal to 5%

The Limit of Detection (LoD) of 2019-nCoV is 400 copies/mL

The test kit has no cross-reactions with other clinically common pathogens including: Coronavirus (229E,OC43,HKU1,NL63),SARS Coronavirus, MERS Coronavirus, Parainfluenza virus (type 1,2,3,4), Respiratory syncytial virus (type A,B),Measles virus, Mumps virus, Cytomegalovirus, Adenovirus (type 3,4,7,11,14,21,55), Enterovirus (CA16, EV71), Influenza A virus (2009H1N1, H1N1, H3N2), Influenza B virus (Victoria, Yamagata), Rhinovirus, HerpesSinplexVirus type 1, EB virus, Mycoplasma pneumoniae, Chlamydia pneumoniae, Streptococcus pneumoniae, Neisseria meningitides, Lactobacillus casei, Neisseria gonorrhea, Bacillus proteus vularis, Escherichia coli, Haemophilus influenza, Pseudomonas aeruginosa, Staphylococcus aureus, Legionella pneumophila,4 / 4 Candida albicans, Shigella flexneri, Aspergillus flavus, Aspergillus fumigatus, Aspergillus niger, Cryptococcus neoformans, Bordetella pertussis, Pertussis bortella, M13 phage, MS2 phage, Collected human nasal rinse solution - representing a variety of microbial flora in the human respiratory tract

The following common interfering substances do not affect the detection of the kit: 2% Blood, 2.5% Mucoprotein, 1.125mg/mL Oxymetazoline, 15% Sodium chloride with preservatives, 5μg/mL Beclomethasone, 5μg/mL Dexamethasone, 5μg/mLTriamcinolone, 5μg/mL Budesonide, 5μg/mL Mometasone, 5μg/mL Fluticasone, 15% Sulfur, 1.7mg/mL Menthol, 0.015mg/mL Zanamivir, 10mg/mL Mupirocin, 0.3mg/mL Tobramycin