General information:

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 and pneumonia. 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.

COVID-19 - an acute respiratory infectious disease. The main manifestations include fever, fatigue and dry cough. Other symptoms might be nasal congestion, runny nose, sore throat, myalgia and diarrhea. Currently, the patients infected by the novel coronavirus are the main source of infection. Asymptomatic infected people can also be an infectious source.

Rhinovirus (Rhv) - usually resides in the upper respiratory tract and mainly causes upper respiratory tract infections such as the common cold in adults. In infants, young children, and patients with chronic respiratory diseases, in addition to upper respiratory tract infections, it can also cause bronchitis and bronchopneumonia.

Influenza (flu) - contagious respiratory illness caused by influenza viruses. Influenza viruses can cause mild to severe illness. Some people, such as older people, young children, and people with certain underlying health conditions, are at higher risk for serious flu complications. There are two main types of influenza viruses: types A B. Both type A and B influenza viruses regularly spread among people, and are responsible for seasonal flu each year.

Respiratory Syncytial Virus (RSV) - the most common virus that causes lower respiratory tract infection in infants and young children. It is mainly transmitted by droplet or direct contact, and the population is generally susceptible. The peak season is from November to April.

Human Adenoviruses - comprise an important group of etiologic agents that are responsible for various diseases in adults and children, such as respiratory, ocular, gastroenteric, and urinary infections. In immunocompromised and organ-transplanted individuals, these agents can cause generalized infections.

Mycoplasma pneumoniae - infection has a worldwide distribution. It occurs through - out the year, most frequently in the colder months. Clinical diagnosis of M.pneumoniae infection is frequently hindered by a lack of specific signs and symptoms, although in the majority of cases increasing cough, malaise, low-grade fever and headache are reported.

Human Metapneumovirus (hMPV) causes mostly a mild self-limited disease. Some patients require hospitalization due to complications such as bronchiolitis, pneumonia, acute exacerbation of chronic obstructive pulmonary disease (COPD), and acute exacerbation of bronchial asthma.

Human parainfluenza viruses (PIV) are a type of virus that often causes lower respiratory tract infections in children, the human parainfluenza virus can cause recurrent upper respiratory tract infections (such as colds and sore throat). It can also cause severe recurrent lower respiratory tract diseases (such as pneumonia, bronchitis, and bronchiolitis), especially in the elderly and immunocompromised population.

Intended use:

This kit is used for in vitro qualitative detection of COVID-19, Rhinovirus (RhV), Influenza A virus (Flu A), Influenza B virus (Flu B), Respiratory syncytial virus (RSV), Adenovirus (ADV), M.Pneumoniae (MP), Human Metapneumovirus (hMPV), Parainfluenza virus 1/3 (PIV1/3) and Parainfluenza virus 2 (PIV 2) antigen in human nasal, nasopharyngeal and oropharyngeal swab samples.

Advantages:

• Quick results - within 12 minutes
• Easy to use - in just 3 quick steps
• Possibility of using nasal, nasopharyngeal and oropharyngeal swab samples
• All necessary reagents provided (individually packaged)
• High sensitivity and specificity

Principle:

The test kit is immunochromatographic and uses latex microspheres method to detection SARS-CoV-2, Rhinovirus (RhV), Respiratory syncytial virus (RSV), Adenovirus (ADV), Influenza A virus, Influenza B virus, Human Metapneumovirus (hMPV), M. pneumoniae (M.P), Parainfluenza virus (PIV) 1/3 and Parainfluenza virus (PIV) 2 antigen. During detection, the treated sample is drop into the sample wells of the test card. When the concentration of SARS-CoV-2, Rhinovirus (RhV), Respiratory syncytial virus (RSV), Adenovirus (ADV), Influenza A virus, Influenza B virus, Human Metapneumovirus (hMPV), M. pneumoniae (M.P), Parainfluenza virus (PIV) 1/3 and Parainfluenza virus (PIV) 2 antigen 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 SARS-CoV-2, Rhinovirus (RhV), Respiratory syncytial virus (RSV), Adenovirus (ADV), Influenza A virus, Influenza B virus, Human Metapneumovirus (hMPV), M. pneumoniae (M.P), Parainfluenza virus (PIV) 1/3 and Parainfluenza virus (PIV) 2 antigen (COVID-19/ RhV/ A&B/ hMPV/ RSV/ ADV/ MP/ PIV 1/3/ PIV 2) 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.

Materials Provided:

• Test Card
• Sterile Swab
• Sample Extraction Buffer
• Instruction for Use
• CE IVD Qualification