QuickVue Influenza A+B test

The QuickVue Influenza A+B test detects & differentiates influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, nasal wash and/or nasal aspirate specimens. Test results are available in 10 minutes or less. The nasal swab sample is 94% sensitive, 90% specific to Influenza type A. See specifications for more performance claims. A single sample can be used to run both the QuickVue Influenza A+B test and QuickVue RSV test.

QuickVue Influenza test

Features & Benefits

Reimbursement Information

The CPT codes provided below are based on AMA coding guidelines and are for informational purposes only. Selection of appropriate codes is the sole responsibility of the billing party. Providers should check with their contracted payers for appropriate codes prior to submitting claims. For questions call 1-866-526-2873 or email sales@americanscreeningcorp.com

Item#:QD-20183

Coding

Influenza A: 87804QW* ($17.52)

Influenza B: 87804QW*,59 ($17.52)

Total Combined Reimbursement: $35.04

Quantity: 25 Tests Per Box

FDA 510K/ CLIA Waived

QuickVue Influenza A+B Test Specification:

About Influenza

Influenza (Flu) is a highly contagious virus that infects the respiratory tract and causes a cascade of symptoms known as "The Flu". In the United States, flu season typically runs from November through April, with the largest number of cases seen between late December and early March. According to the United States Centers for Disease Control and Prevention (CDC), influenza infections cause more than 200,000 hospitalizations and 36,000 deaths annually. In healthy adults, bronchitis and pneumonia (primary viral and secondary bacterial) are the most common complications of influenza. Together, influenza and pneumonia are the 6th leading cause of death in the United States. Influenza may be particularly fatal in the elderly and immunocompromised (cancer patients, those with HIV infection, individuals receiving steroids, chemotherapy, or radiation therapy). Influenza infection compromises the mucociliary lining of the respiratory tract and makes individuals susceptible to such bacterial agents as Staphylococcus aureus, Streptococcus pneumonia, and Hemophilus influenza. Other complications of influenza infection include encephalitis and meningitis. Otitis media, croup and primary viral pneumonia and secondary bacterial pneumonia are influenza complications found in children. Reye's Syndrome is another potential complication from influenza infection that is found in children between the ages of 6 and 11 on long-term aspirin therapy.
Influenza replication takes place within the host respiratory epithelial cells. The incubation period lasts 1-3 days during which time the virus spreads to nearby columnar cells of the respiratory epithelium. After 1-3 days there is usually enough influenza virus present to cause the clinical symptoms associated with influenza infection. Adults will "shed" influenza virus for approximately 7 days following infection during which time they are considered contagious and capable of spreading the infection. Children and individuals with a compromised immune system may "shed" virus for up to 2 weeks during which time they remain contagious. Infected respiratory epithelium demonstrates significant necrosis which predisposes the infected individual to a secondary bacterial infection.
The onset of flu symptoms is abrupt and characterized by fever (up to 104 degrees F), chills, myalgia, headache, lumbosacral backache, weakness, pharyngitis, and a dry cough. Fever usually lasts 2-4 days. The other symptoms, especially cough and malaise, may persist for up to 2 weeks. Unlike adults, children may present with vomiting and diarrhea. Physical examination may demonstrate evidence of conjunctivitis, nasal discharge, hyperemic pharyngeal mucosa without exudate, cervical adenopathy and rarely rales.
The influenza viruses are RNA viruses from the family Orthomyxoviridae and are identified as either type A or type B based upon the immunoreactivity of the viral nucleoprotein (NP). The nucleoprotein is associated with the 8 unique viral RNA segments. Together the NP and RNA form the viral ribonucleoprotein. A lipid envelope surrounds the internal ribonucleoprotein and contains the viral hemagglutinin protein (HA) and neuraminidase (NA) protein antigens that project outward from the lipid envelope. The human influenza type A strains are identified by the presence of the hemagglutinin protein (H1, H2, H3) and by the presence of the neuraminidase protein (N1, N2). The influenza virus A strain is thus identified, for example, as an H1N2 virus. The influenza virus strains are also identified by the location where they were isolated, the isolate number and the year of isolation. For example, an H1N3 influenza type A virus isolated from the eighth individual from whom a clinical sample was obtained in Puerto Rico in 1934 would be identified as A/PR/8/34 (H1N3).
Vaccination is the primary means to protect an individual from influenza and help prevent the spread of disease. The inactivated vaccine is highly purified and 70-90% effective in preventing influenza in healthy adults. In addition, vigilance in handwashing and avoiding close contact with known infected individuals are also important in preventing the spread of influenza. The Advisory Committee on Immunization Practices (ACIP) has identified specific "high risk" individuals who should receive the vaccine. These individuals have the greatest potential of developing severe disease or complications:

Children aged 6-23 months

People aged 50 years and older.

People with chronic heart, lung, or kidney disease, diabetes, immunosuppression, or severe forms of anemia.

Residents of nursing homes or other chronic care facilities.

Women who will be over 3 months pregnant during the influenza season.

Children and teens receiving long-term aspirin therapy. These individuals may be at risk for developing Reye's Syndrome following influenza infection.

People who live or work with high-risk patients.

The following individuals should also receive the vaccine because they have the greatest potential to transmit influenza to "high risk" individuals:

Healthcare workers

Employees of nursing homes and other chronic care facilities

The vaccine is contraindicated in individuals with a prior allergic reaction to the vaccine and in individuals allergic to eggs. Individuals with an acute febrile illness should wait until their symptoms subside before receiving the vaccine.
There are four anti-viral drugs currently available which are potentially effective in decreasing the severity and duration of the flu symptoms. These drugs are most effective when administered within 48 hours of the onset of symptoms. Rapid and accurate diagnosis of influenza at the point of care is paramount in order to ensure that an individual is able to benefit from these anti-viral medications.
The QuickVue® Influenza test and QuickVue® Influenza A+B test are point-of-care, lateral flow, immunodiagnostic tests designed to detect the presence of the influenza A and B virus in patient nasal swab, nasopharyngeal swab and nasal wash/aspirate specimens within 10 minutes. A positive test result is visually detected as a red test line. The test has a bulit-in procedure control that will appear as a blue colored line.
The QuickVue® Influenza test technology utilizes the principle of antibody specificity for the influenza virus nucleoprotein (NP) to selectively interact with the influenza A and B viruses. The NP is evolutionarily highly conserved and not subject to the same year-to-year changes that make it necessary to be vaccinated each year to prevent influenza infection. For this reason the QuickVue® test is not adversely affected by the appearance of different influenza strains.

Additionally, the QuickVue® Influenza A+B test has been shown to detect cultured avian influenza viruses; however, as with other rapid tests for influenza, the ability of the QuickVue® Influenza A+B test to detect influenza A in patients infected with H5N1 has not been established.
The QuickVue® Influenza test is a simple, 3-step, 1-reagent, 10-minute test that requires less than 90 seconds hands-on time. The test has a shelf life of 24 months from date of manufacture and can be stored at room temperature. No additional instrumentation is required to perform the test. The QuickVue® test is the first CLIA-waived rapid influenza test. The QuickVue® Influenza test combines speed, simplicity and accuracy all in one test.

The QuickVue® brand Influenza Test
Swine Flu: Question and Answers

Does the QuickVue brand Influenza test identify the human swine influenza A (H1N1) virus circulating?
• The ability of Quidel’s QuickVue influenza tests to detect this new strain of virus has not been determined.

Quidel Corporation A+B influenza test kits:
1- The QuickVue Influenza A+B test will detect seasonal, human influenza A, subtypes H1N1 and H3N2, and influenza B. It will distinguish influenza A and B.

• As for the ability of Quidel’s influenza tests to detect the new virus, it is not known if either test will detect the swine influenza H1N1 now circulating.

What should healthcare providers do if they perform a rapid influenza test and receive a positive result?
• If a positive result is obtained, the CDC requests that healthcare providers inform their regional public health laboratory promptly and obtain an additional patient specimen for quick transfer to that laboratory for further characterization of the virus.