INTENDED USE

The SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2, Influenza A, Influenza B and Respiratory Syncytial Virus(RSV) antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2/Influenza/RSV infection in conjunction with clinical presentation and the results of other laboratory tests.
Results are for the detection of SARS-CoV-2, Influenza A+B and RSV Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out other bacterial/viral infection The agent detected may not be the definite cause of disease.
Negative results do not preclude SARS-CoV-2/Influenza A+B/RSV infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in
the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-CoV-2, Influenza A+B and RSV.
The SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test is intended for use by trained clinical laboratory personnel.

SUMMARY

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.
Influenza (commonly known as ‘flu’) is a highly contagious, acute viral infection of the respiratory tract. It is a communicable disease easily transmitted through the coughing and sneezing of aerosolized droplets containing live virus. Laboratory identification of human influenza virus infections is commonly performed using direct antigen detection, virus isolation in cell culture, or detection of influenza-specific RNA by reverse transcriptase-polymerase chain reaction (RT-PCR). Rapid tests for influenza A and B virus infections, which can provide results within 30 minutes.
Respiratory Syncytial Virus (RSV), which causes infection of the lungs and breathing passages, is a major cause of respiratory illness in young children. In adults, it may only produce symptoms of a common cold, such as a stuffy or runny nose, sore throat, mild headache, cough, fever, and a general feeling of being ill.Most children with RSV infection, both those who were hospitalized and those who were treated as outpatients, had no coexisting medical conditions or characteristics that significantly identified them as being at greater risk for severe RSV disease, except for being under 2 years of age.

PRINCIPLES

The SARS-CoV-2 Antigen Rapid Test is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 Antigens in human nasopharyngeal swab specimen.
SARS-CoV-2 antibody is coated in test line region. During testing, the specimen reacts with SARS-CoV-2 antibody-coated particles in the test. The mixture then migrates upward on the membrane by capillary action and reacts with the SARSCoV-2 antibody in test line region. If the specimen contains SARS-CoV-2 antigens, 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, 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.
The Influenza A+B Rapid Test (Nasopharyngeal Swab) is a qualitative, lateral flow immunoassay for the detection of Influenza A and Influenza B nucleoproteins in human nasopharyngeal swab specimen. In this test, antibody specific to the Influenza A and Influenza B nucleoproteins is separately coated on the test line regions of the test. During testing, the extracted specimen reacts with the antibody to Influenza A and/or Influenza B that are coated onto particles. The mixture migrates up the membrane to react with the antibody to Influenza A and/or Influenza B on the membrane and generate one or two colored lines in the test regions. The presence of this colored line in either or both of the test regions indicates a positive result. To serve as a procedural control, a colored line will always appear in the control region if the test has performed properly.
The RSV Rapid Test is a qualitative, lateral flow immunoassay for the detection of Respiratory Syncytial Virus nucleoproteins in nasopharyngeal swab specimens. In this test, antibody specific to the Respiratory Syncytial Virus nucleoproteins is coated on the test line region of the test. During testing, the extracted specimen reacts with the antibody to Respiratory Syncytial Virus that is coated onto particles. The mixture migrates up the membrane to react with the antibody to Respiratory Syncytial Virus on the membrane and generate one colored line in the test region. The presence of this colored line in the test region indicates a positive result. To serve as a procedural control, a colored line will always appear in the control region if the test has performed properly.