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 COVID-19.COVID-19 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.
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 (COVID-19/Respiratory Syncytial virus/Influenza A virus/Influenza B virus from human nasal swabs specimens.REAGEN QuadSure COVID-19 & Flu A/B & RSV 4-in-1 Rapid Test is an immunochromatographic double-antibody sandwich assay intended for the qualitative detection and differentiation of COVID-19/Respiratory Syncytial virus/Influenza A virus/Influenza B virus 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.

Principle

The test kit is immunochromatographic and uses latex microspheres method to detection COVID-19,Respiratory syncytial virus,Influenza A virus,Influenza B virus antigen. During detection, the treated specimens are loaded into the sample wells of the test card.When the concentration of COVID-19/Respiratory Syncytial virus/Influenza A virus/Influenza B virus in specimen is 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/Influenza A virus/Influenza B virus in detection zone on nitrocellulose film(COV/A/B/RSV) to form a blue reaction line on the detection zone at this point the result is positive. Conversely, if there is no viral antigen or the concentration of antigen in specimen is below the minimum detection limit, no blue reaction line appears in the detection zone, 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 zone(C), the blue reaction line that appears in the quality control zone(C) is the criterion for determining if the
chromatography process is normal.