Influenza A+B Antigen Rapid Test

Explain ：

Nasopharyngeal Swab sample
Insert a sterilized swab into a nasal cavity securely from a nostril and collect mucoepidermis wiping turbinate several times. Pharyngeal swab sample insert a sterilized swab into pharynx and collect mucoepidermis mainly wiping flare region of post-pharyngeal wall and palatine tonsil several times, and be careful not to make saliva attach to the swab. Nasopharyngeal aspirate Connect an aspiration catheter to an aspiration trap that is attached to an aspiration device, insert the catheter to nasal cavity from a nostril, start the aspiration device and then collect nasal aspirate sample. Dip a sterilized swab into the collected nasal aspirate sample and make the specimen cling to the swab.

 Influenza (commonly known as ‘flu’) is a highly contagious, acute viral infection of the respiratory tract .It is a communicable disease easily transmitted through the coughing and sneezing of aerosolized droplets containing live virus.1 Influenza outbreaks occur each year during the fall and winter months. Type A viruses are typically more prevalent than type B viruses and are associated with most serious influenza epidemics, while type B infections are usually milder. The gold standard of laboratory diagnosis is 14-day cell culture with one of a variety of cell lines that can support the growth of influenza virus.2 Cell culture has limited clinical utility, as results are obtained too late in the clinical course for effective patient intervention. Transcriptase Polymerase Chain Reaction (RT-PCR) is a newer method that is generally more sensitive than culture with improved detection rates over culture of 2-23%.3 However, RT-PCR is expensive, complex and must be performed in laboratories.
The Influenza A+B Rapid test Device (Swab/Nasal Aspirate) qualitatively detects the presence of Influenza A and/or Influenza B antigen in nasal swab or throat swab or nasal aspirate specimens ,providing results within 15 minutes. The test uses antibodies specific for Influenza A and Influenza B to selectively detect Influenza A and Influenza B antigen in nasal swab, throat swab or nasal aspirate specimens.

Introduction

Intend to use

The Influenza A+B Rapid test Device is a rapid chromatographic immunoassay for the qualitative detection of influenza A and B antigens in nasal swab or throat swab or nasal aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections.

Performance Characteristic

1.Positive Coincidence Rate:100%

2.Negative Coincidence Rate:100%

3.Analytical Sensitivity:The detection value of Influenza A should be 1.3×10⁴ TCID₅₀

           The detection value of Influenza B should be 9.2×10⁴ TCID₅₀

Operating  Steps