Beright SARS-CoV-2/ Influenza A+B/ RSV/ Adenovirus/ Mycoplasma pneumoniae Antigen Combo Rapid Test

General information: 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. 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. Intended use: Beright is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2, Influenza A+B, RSV, Adenovirus and M.pneumoniae antigens in human nasopharyngeal swab specimens. Advantages: Fast results within 15 mins High Sensitivity, Specificity and Accuracy Detection of two pathogens simultaneously Principle: The Beright SARS-CoV-2/ Influenza A+B/ RSV/ Adenovirus/ Mycoplasma pneumoniae Antigen Rapid Test (Nasopharyngeal Swab) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 / Influenza A+B/ RSV/ Adenovirus/ Mycoplasma pneumoniae in human nasopharyngeal swab specimen. SARS-CoV-2/ Influenza A+B/ RSV/ Adenovirus/ Mycoplasma pneumoniae antibody is coated in test line region. During testing, the specimen reacts with SARS-CoV-2/ Influenza A+B/ RSV/ Adenovirus/ Mycoplasma pneumoniae antibody-coated particles in the test. The mixture then migrates upward on the membrane by capillary action and reacts with the SARS-CoV-2/ Influenza A+B/ RSV/ Adenovirus/ Mycoplasma pneumoniae antibody in test line region. If the specimen contains SARS-CoV-2/ Influenza A+B/ RSV/ Adenovirus/ Mycoplasma pneumoniae , a colored line will appear in test line region as a result of this. If the specimen does not contain antigens to SARS-CoV-2/ Influenza A+B/ RSV/ Adenovirus/ Mycoplasma pneumoniae , no colored line will appear in the test line region, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred. Performance characteristics: Analytes Sensitivity Specifity Accuracy SARS-CoV-2 96.4% 99.0% 98.2% Flu A 95.0% 99.1% 98.4% Flu B 92.9% 99.1% 98.1% RSV 94.3% 96.2% 95.9% Adeno 96.9% 98.6% 98.4% MP 91.8% 98.0% 97.0% Materials Provided: Extraction Tubes and Tips (Optional) Sterile Swabs Instruction for use Workstation Test Cassettes CE-IVD certificate