INTRODUCTION

The coronavirus (CoV) belongs to the order Nidovirales under the family Coronaviridae with 4 genera: α, β, γ and δ. The genera α and β are only for Mammals are pathogenic, while genera γ and δ are mainly pathogens in birds cause infections.CoV is mainly transmitted through direct contact with secretions orby aerosols and droplets. But there is also evidence for onefecal-oral transmission.So far, 7 types of human coronaviruses (HCoV) have been identified thatcause respiratory diseases in humans, including: HCoV-229E, HCoV-NL63, HCoV-OC43, HCoV-HKU1, SARS-CoV, MERS-CoV and SARS-CoV-2.SARS-CoV-2 is one of the most contagious viral pathogens that human respiratory infections (RTI). Currently, patients who with SARS-CoV-2, the main source of infection. Asymptomatic infected people can also be a source of infection. According to the current epidemiological investigations, the Incubation period 1 to 14 days, mostly 3 to 7 days. to the clinical symptoms include fever, fatigue, cough and other symptoms, accompanied by shortness of breath, which can quickly progress to severe, life-threatening pneumonia, respiratory failure, acute respiratory vesicle syndrome, septic shock, multiple organ failure and severe metabolic acid-base imbalance.

Respiratory syncytial virus belongs to the Pneumovirus genus of the Paramyxoviridae family. It can be transmitted through the air and through close contact, mainly causing lower respiratory tract infections such as bronchiolitis and pneumonia in infants under 6 months old, and upper respiratory tract infections such as rhinitis and colds in older children and adults. Clinically, patients with respiratory syncytial virus infection can present with fever, nasal congestion, dyspnea, and even respiratory failure or heart failure when the symptoms are severe, and active treatment is required.

Adenovirus（ADV） is an unenveloped DNA virus that mainly infects a wide variety of vertebrates, including humans. Human infection can lead to a variety of clinical manifestations and diseases, including respiratory diseases (such as the common cold, bronchitis, pneumonia, etc.), digestive tract diseases (such as diarrhea, gastroenteritis, etc.), conjunctivitis and cystitis. Individual cases can become severe and critical, and even die. Influenza, commonly referred to as the flu, is an acute respiratory infection by the influenza virus is caused. It is highly contagious. It will mainly by coughing and sneezing and usually breaks out in spring and winter. It is mainly divided into influenza A and influenza B viruses. Influenza A viruses are highly variable, followed by influenza B viruses. Therefore are Influenza A viruses more common and severe, followed by influenza B viruses.Influenza A includes H1N1, H3N2, H5N1, H7N9, and influenza B includes influenza B (Victoria) and Influenza B (Yamagata).

INTENDED USE

This kit is only used for the in vitro qualitative detection of Multiple Respiratory Multipathogen Antigen SARS-CoV-2/Respiratory Syncytial virus/Influenza A virus/Influenza B virus/Adenoviruses) from human nasopharyngeal swabs specimens.SARS-CoV-2/RSV/ADV&Flu A/B Antigen Rapid Test Kit is an immunochromatographic double-antibody sandwich assay intended for the qualitative detection and differentiation of SARS-CoV-2/Respiratory Syncytial virus/Influenza A virus/Influenza B virus/Adenoviruses 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 historyother laboratory tests and treatment responses, Positive test result needs to be further confirmed negative result does not preclude respiratory diseases viruses infection.

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.
• If the SARS-CoV-2 test is positive, there is a suspicion of a COVID-19 infection, contact your doctor/GP immediately or the local health department, follow local guidelines Self-isolate and perform a confirmatory PCR test.

• If the result of the ADV, RSV, influenza A/B test is positive: There is currently the Suspected ADV, RSV, influenza A/B infection and what to do next be undertaken according to local guidelines.

• 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.