INTRODUCTION

Acute respiratory infection is a common and frequently occurring disease worldwide. Respiratory virus is an important pathogen of acute respiratory infection. Its clinical manifestations are mainly rhinitis,pharyngitis,laryngitis, Tonsillitis and other symptoms. Severe cases can cause tracheitis, bronchitis andpneumonia. It is the main cause of morbidity and mortality in winter and spring for young children, the elderly and the infirm, and those with low immune function. It has been proven that 80% of acute upper respiratory diseases and most lower respiratory diseases are caused by pathogens outside of bacteria, with respiratory viruses being the most common.

INTENDED USE

This kit is used for in vitro qualitative detection of COVID-19, Influenza A virus, Influenza B virus,Respiratory syncytial virus (RSV) , Adenovirus (ADV), M.Pneumoniae(MP) and Parainfluenza virus(PIV, type 1,2,3,4) antigen in human nasal swab samples.

PRINCIPAL

The test kit is immunochromatographic and uses latex microspheres method to detection COVID-19, Respiratory syncytial virus,Adenovirus,Influenza A virus,Influenza B virus,M.pneumoniae,Parainfluenza virus antigen. During detection, the treated sample is drop into the sample wells of the test card.When the concentration of COVID-19, Respiratory syncytial virus,Adenovirus,Influenza A virus,Influenza B virus, M.pneumoniae,Parainfluenza virus in samples are higher than the minimum detection limit, the viral antigen will form complexes with labeled antibodies first. Under chromatography, the complexes move forward along the nitrocellulose membrane till captured by pre-coated monoclonal antibody of COVID-19,Respiratory syncytial virus,Adenovirus,Influenza A virus,Influenza B virus,M.pneumoniae,Parainfluenza virus in detection area(COV/A/B/RSV/ADV/MP/PIV)on nitrocellulose film to form a blue reaction line on the detection area at this point the result is positive. Conversely, if there is no viral antigen or the concentration of antigen in sample is below the minimum detection limit, no blue reaction line appears in the detection area, at this point the result is negative.Regardless of whether the sample contains viral antigens or not, a blue reaction line will appear in the quality control area(C),the blue reaction line that appears in the quality control area (C) is the criterion for determining if the chromatography process is normal.

WARNINGS AND PRECAUTIONS

• This test kit is for in vitro diagnostic use only.
• This test kit is intended for persons aged 18 and over.
• Bring the contents of the kit to room temperature before testing.
• Appropriate protection should be worn while performing the test to avoid splashes when adding the sample.
• Do not reuse the test kit.
• Do not use the test kit if the pouch breaks the seal broken or the test cassette is wet or dirty.
• Do not use the contents of the test kit after the expiry date on the expiry date printed on the outside of the
packaging.