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Antigen Rapid Diagnostic Test Kit , Nasal Swab / Throat Swab Test Kits

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Address: Huafa Mansion, Binhu District, Wuxi, Jiangsu Province, China

Contact name:Soohia

Wuxi Owgels Medical Instruments Co., Ltd

Antigen Rapid Diagnostic Test Kit , Nasal Swab / Throat Swab Test Kits

Country/Region	china
City & Province	wuxi jiangsu

Product Details

Antigen Rapid Diagnostic Test Nasal Swab Fast Test Throast SwabTest Kits Antigen Test 

Cross Reactivity

Many types of pneumonia are companied by fever, cough and other respiratory symptoms. In order to eliminate similar clinical symptoms of other types of pneumonia effects, pneumonia mycoplasma, influenza A, pneumococcus etc. were detected for the specific assessment. Each of the organism and viruses were tested in the absence or presence of heat inactivated SARS-CoV-2 virus (308 TCID₅₀/ml), No cross-reactivity or interference was seen.

Potential Cross-Reactant	Test Concentration	Result
Potential Cross-Reactant	Test Concentration	Absence of SARS-CoV-2	presence of SARS-CoV-2
Staphylococcus aureus	1.0×10⁵ TCID₅₀/ml	－	+
Streptococcus pneumoniae	1.0×10⁶ Cells/ml	－	+
Measles virus	1.0×10⁵ TCID₅₀/ml	－	+
Mumps virus	1.0×10⁵ TCID₅₀/ml	－	+
Adenovirus type 3	1.0×10⁵ TCID₅₀/ml	－	+
Mycoplasma pneumoniae MP	1.0×10⁶ Cells/ml	－	+
Parainfluenza type 2	1.0×10⁵ TCID₅₀/ml	－	+
Metapneumovirus	1.0×10⁵ TCID₅₀/ml	－	+
Coronavirus OC43	1.0×10⁵ TCID₅₀/ml	－	+
Coronavirus 229E	1.0×10⁵ TCID₅₀/ml	－	+
Bordetella parapertussis	1.0×10⁶ Cells/ml	－	+
Influenza B virus (Victoria series)	1.0×10⁵ TCID₅₀/ml	－	+
Influenza B virus (Y series)	1.0×10⁵ TCID₅₀/ml	－		+
Influenza A H1N1 (2009) virus	1.0×10⁵ TCID₅₀/ml	－		+
Influenza A H3N2 virus	1.0×10⁵ TCID₅₀/ml	－		+
Avian influenza virus H7N9	1.0×10⁵ TCID₅₀/ml	－		+
Avian influenza virus H5N1	1.0×10⁵ TCID₅₀/ml	－		+
EB virus	1.0×10⁵ TCID₅₀/ml	－		+
Enterovirus CA16	1.0×10⁵ TCID₅₀/ml	－		+
Rhinovirus	1.0×10⁵ TCID₅₀/ml	－		+

Interference

Potential Endogenous Interference of the COVID-19 Antigen Rapid Test was evaluated using natural clinical samples. No Antigen false negative or false positive results were observed with the following potential interference substances at the stated concentrations:

Human Blood	1% V/V
Mucosal protein	1mg/ml
Phenylephrine	1% V/V
Oxymetazoline	1% V/V
Triamcinolone	50mg/L
Ribavirin	50mg/L

Overall Clinical Performance of Antigen Test Kit

A total of above 157 positive samples and 260 negative samples were detected to evaluate the clinical performance of the COVID-19 Antigen Rapid Test Kit. The Result is below: