BioTeke - SARS-CoV-2 / Flu A / Flu B / RSV / ADV / MP Antigen Rapid Test Kit

A. Intended Use:

     When it comes to SARS-CoV-2,Flu A, Flu B ,Respiratory Syncytial Virus (RSV) ,Adenovirus and Mycoplasma Pneumoniae 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
• Accurate, 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:

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. Product qualifications(By Sept.22,2023)