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INTENDED USE The QuickVue Influenza Test is a simple to use, rapid, qualitative lateral flow immunoassay for the detection of Influenza Virus type A and type B antigens directly from a self administered nasal specimen swab. The test kit is self contained and intended for use as an aid in the rapid diagnosis of acute influenza virus infection. SUMMARY
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EXPLANATION Influenza is highly contagious, acute, viral infection of the respiratory tract. The causative agents of the disease are immunologically diverse, single-strand RNA viruses known as influenza viruses. There are three types of influenza viruses: A, B, and C. Type A viruses are the most prevalent and are associated with most serious health risks and epidemics. Type B viruses promote a disease that is generally milder then that caused by type A. Type C viruses are a highly stable and less infectious causing either minor discomfort or no symptoms at all. All influenza viruses are contracted primarily by the inhalation of airborne contaminated micro droplets from other infected individuals. Because the disease is so contagious, influenza can be epidemic in proportions infecting many individuals at the same time. The virus primarily attacks the respiratory track weakening the immune system and potentially leading to serious complications like pneumonia especially in the elderly with other chronic health problems. The early diagnosis of influenza is useful in prescribing the correct medications and recuperative treatment for the disease. Recently, antibiotic treatment of influenza has been developed. Drugs called neuraminidase inhibitors, as well as Amantadine and Rimantadine, are effective in decreasing symptoms if given within two days of the onset of symptoms. These drugs can also prevent influenza in patients at high risk, including the elderly or those with immune deficiency, when given during epidemics to unvaccinated patients. PRINCIPLE OF THE TEST The QuickVue© Influenza Test involves the extraction of influenza A and B viral antigens. A swab containing a nasal discharge specimen is placed in a special extraction tube with the supplied test reagent solution during which time the virus particles in the specimen are disrupted, exposing internal viral nucleoproteins. The Influenza Test Strip is then placed in the extracted reagent solution where nucleoproteins in the specimen will react with the reagents impregnated on the test strip. If the extracted specimen contains influenza antigens, a pink-to-red Test Line along with a blue procedural Control Line will appear on the Test Strip indicating a positive result. If influenza type A or type B antigens are not present or are present at very low levels, only a blue procedural Control Line will appear. For information including specificity, sensitivity, expected values, cross reactivity and analytical data see the Influenza AB Test Technical Insert. TEST COMPONENTS SUPPLIED: Each QuickVue Influenza AB test kit comes boxed containing all the materials required to perform twenty-five (25) test procedures:
TEST BASICS:
The QuickVue© Influenza Test is available in a clinical/physicians boxed kit of 25 test procedures. Each QuickVue© influenza boxed test kit is sealed with all the required test components to perform 25 Influenza AB test procedures. Clear step by step instructions are included with each test kit. Physician CPT Code 87804.
Influenza AB Test Technical Insert
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