Sars-Cov-2 Antigen + Flu A/B Rapid Test – Codice Prodotto: SC-1262-20
The Covid-19 Antigen Rapid Swab and Influenza A + B (nasopharyngeal swab) is a rapid immunochromatographic test for the qualitative detection of the antigens of the Sars-CoV-2, Influenza A and Influenza B viruses present in the human nasopharynx. For professional in vitro diagnostic use only. The separate results indicate the detection of Sars-CoV-2 and Influenza A + B antigens. The antigen is generally detectable in upper respiratory tract samples during the acute phase of the infection. Positive results indicate the presence of viral antigens, but a clinical correlation with the patient’s medical history and other diagnostic information is required to determine the infectious state. The positive results do not exclude bacterial infection or co-infections with other viruses. The identified agent may not be the determining cause of the disease. The result is separate for Covid-19, Influenza A and Influenza B. The combined rapid test for COVID-19 antigens and influenza A + B (nasopharyngeal swab) is a rapid immunochromatographic test for the qualitative detection of the SARS-CoV-2 nucleocapsid protein , influenza A and influenza B virus antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2 / Influenza infection in combination with clinical presentation and other laboratory test results. The results indicate the identification of the SARS-CoV-2 nuclecapsid protein and Influenza A + B. The antigen is generally detectable in upper respiratory tract samples during the acute phase of the infection. Positive results indicate the presence of viral antigens, but a clinical correlation with the patient’s medical history and other diagnostic information is required to determine the infectious state. The positive results do not exclude bacterial infection or co-infections with other viruses. The identified agent may not be the determining cause of the disease. Negative results do not exclude SARS-CoV-2 / Influenza A + B infection and should not be used as the sole basis for therapy or other patient management decisions, including infection control. Negative results should be treated as preliminary and confirmed by a molecular test if necessary for patient management. Negative results should be evaluated at the same time as recent exposures, patient history and in the presence of clinical signs and symptoms compatible with COVID-19 / Influenza A + B. The new coronavirus belongs to the β genus. COVID-19 is an acute expiratory infectious disease. It mainly affects humans. Patients infected with the new coronavirus are currently the main source of infection; even asymptomatic infected individuals can be a source of infection. Based on the current epidemiological survey, the incubation period is 1 to 14 days, mostly 3 to 7 days. The most common manifestations include fever, fatigue, and dry cough. Nasal congestion, runny nose, sore throat, myalgia, and diarrhea are also present in some cases. Influenza is an acute, highly contagious viral infection of the respiratory tract. It is a disease that is easily transmitted by coughing and emitting aerosol droplets containing the live virus1. The spread of the flu occurs every year during the autumn and winter months. Viruses A are typically more prevalent than type B and are associated with more serious influenza outbreaks, while type B infections are generally milder. the gold standard of laboratory diagnosis is 14-day cell culture with one of the varieties of cell lines that can support the growth of the influenza virus. Cell culture has limited clinical utility, since the results arrive too late in the clinical course for an effective intervention on the patient. Polymerase-Reverse Transcriptase Chain Reaction (RT-PCR) is the most innovative method generally more sensitive than the culture with better detection rates than cultures of 2-23%. However, RT-PCR is expensive, complex and must be performed by specialized laboratories. The COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab) is a qualitative membrane-based immunoassay for the detection of SARS CoV-2 nucleocapsid protein in nasopharyngeal swab samples. The test line area is coated with SARS-CoV-2 antibody. During testing, the sample reacts with the SARS-CoV-2 antibody coated particles on the device. The compound then migrates upwards by capillary action and reacts with the SARS-CoV-2 antibody in the test line area. If the sample contains SARS-CoV-2 Antigens a colored line will form in the test area as a result. If the sample does not contain SARS-CoV-2 Antigens, no colored line will form in the test area indicating a negative result. As a procedural control, a colored line will always appear in the control zone, indicating that enough sample has been spilled and the membrane has absorbed it correctly. The Influenza A + B rapid test (nasopharyngeal swab) is a qualitative lateral scrolling immunoassay for the detection of Influenza A and Influenza B antigen in human nasopharyngeal swab samples. In this test, the specific antibody of Influenza A and Influenza B covers two separate areas of the test line area. During the test, the extracted sample reacts with the Influenza A and / or Influenza B antibody that cover the particles. The compound migrates upward on the membrane reacting with the Influenza A and / or Influenza B antibody on the membrane and generates one or two colored lines in the test areas. The presence of this colored line in one or both areas of the test indicates a positive result. As a procedural control, a colored line will always appear in the test control area if the test is working correctly.