Multiple Respiratory Multipathogen Antigen Test Kit (3 Results & 4 Results & 5 Results)

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A. Intended Use:

     This kit is only used for the in vitro qualitative detection of Multiple Respiratory Multipathogen Antigen from human nasopharyngeal swabs specimens. Multiple Respiratory Multipathogen Antigen Test Kit is an immunochromatographic double-antibody sandwich assay intended for the qualitative detection and differentiation of SARS-CoV-2/Influenza A virus/Influenza B virus /Respiratory syncytial virus and Adenovirus antigen from individuals who are suspected of respiratory tract disease infection.

    This kit is suitable for the auxiliary diagnosis of respiratory diseases, the results are for clinical reference only and cannot be used as the sole basis for diagnosis and exclusion decision. The clinical diagnosis and treatment of patients should be considered in combination with their symptoms/signs, medical history, other laboratory tests and treatment responses. Positive test result needs to be further confirmed, negative result does not preclude respiratory diseases viruses infection.

    This kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures.

B. Three  Options:

a. 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).

b. 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:

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

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

C. Advantages

  a. Superior performance and high accuracy.

  b. The multi-color system is more conducive to the interpretation of inspector and can help reduce the chance of misjudgment.

  c. Two-way chromatography, one sampling, multiple detections.Operators' detection steps will be simpler.

  d. Automation degree is high, and the production efficiency is several times higher than that of other enterprises.

  e. Lower cost.

  f. The product form is flexible.Multiple inspections can be combined according to customers' requirements.

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