Bioteke CE Certified Respiratory Multipathogen Antigen Rapid Test Kits

A. Intended Use:

     When it comes to Covid 19, Flu A, Flu B ,Respiratory Syncytial Virus (RSV) ，Adenovirus(ADV) and Mycoplasma Pneumoniae(MP) testing, Results from Bioteke SARS-Cov-2/Flu A /Flu B /RSV/ADV /MP antigen test kit allow physicians to make a rapid diagnosis with confidence, which is essential for reducing secondary testing, decreasing unnecessary antibiotic use, and guiding appropriate antiviral therapy.

B. Advantages:

• Patent design - Two-way chromatography ,only single sample well.

• Compact card better friendly to the environment.

• Multi-color display results，Easy-to-read results in 15 minutes.

• High Sensitivity, Specificity and Accuracy, reliable results.

• Long shelf life to adapt to seasonal fluctuations.

• Variety of collection and transport options.

• Convenient room temperature storage.

C.Result Analysis

• SARS-CoV-2: Specificity: 100%  ; Sensitivity 96.08% ; Total Coincidence Rate : 99.47%

• Influenza A : Specificity: 100% ; Sensitivity 98.4% ; Total Coincidence Rate : 99.82%

• Influenza B : Specificity: 100%  ; Sensitivity 96.8% ; Total Coincidence Rate : 99.65%

• RSV : Specificity : 100%  ; Sensitivity 97.98% ; Total Coincidence Rate : 99.82%

• Adenovirus : Specificity : 100% ；Sensitivity 95.83% ; Total Coincidence Rate : 99.56%

• M.Pneumoniae : Specificity: 100%  ; Sensitivity 97.98% ; Total Coincidence Rate : 99.82%

D. Four Options:

a. SARS-CoV-2/Flu A/Flu B/RSV/ADV/MP Antigen Rapid Test Kit (6 Results of Diseases)

This kit can be detected six items: SARS-CoV-2 , Influenza A virus , Influenza B virus , Respiratory syncytial virus , Adenovirus antigen and Mycoplasma Pneumoniae.

b. Multiple Respiratory Multipathogen Antigen Test Kit (5 Results of Diseases)

This kit can be detected five items: SARS-CoV-2、Influenza A virus 、Influenza B virus 、Respiratory syncytial virus and Adenovirus antigen.

c. Multiple Respiratory Multipathogen Antigen Test Kit (4 Results of Diseases)

This kit can be detected four items: SARS-CoV-2、Influenza A virus 、Influenza B virus and Respiratory syncytial virus. 

（a）These antigen tests are included under “Category A” of the EU common list:

Prospective clinical field study

Study in Poland.Sample size : 103 positive ,325 negative .Sensitivity:90.29% ; specificity:99.04%

d. Multiple Respiratory Multipathogen Antigen Test Kit (3 Results of Diseases)

This kit can be detected three items: SARS-CoV-2、Influenza A virus and Influenza B.

E. Related Products

Multiple Respiratory Pathogens Nucleic Acid Detection Kit 

E. Product qualifications（By Sept.22,2023）

Multiple Respiratory multipathogen antigen test kit

Malaysia Registration

CE Certification – CIBG Registration Letter

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CE Certification–EC Declaration of Conformity

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