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The Acucy Influenza A&B Test is a rapid chromatographic immunoassay for the qualitative detection and differentiation of influenza A and B viral nucleoprotein antigens directly from anterior nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. The test is intended for use with the Acucy or Acucy 2 Reader as an aid in the diagnosis of influenza A and B viral infections. The test is not intended for the detection of influenza C viruses. Negative test results are presumptive and should be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2017-2018 influenza season when influenza A/H3N2 and A/H1N1pdm09 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If an infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

The Acucy Influenza A&B Test allows for the differential detection of influenza A and influenza B antigens, when used with the Acucy 2 Reader. The patient sample is placed in the Extraction Buffer vial, during which time the virus particles in the sample are disrupted, exposing internal viral nucleoproteins. After disruption, the sample is dispensed into the Test Cassette sample well. From the sample well, the sample migrates along the membrane surface. If influenza A or B viral antigens are present, they will form a complex with mouse monoclonal antibodies to influenza A and/or B nucleoproteins conjugated to colloidal gold. The complex will then be bound by a rat anti-influenza A and/or mouse anti-influenza B antibody coated on the nitrocellulose membrane. Depending upon the operator's choice, the Test Cassette is either placed inside the Acucy 2 Reader for automatically timed development mode (WALK AWAY Mode) or placed on the counter or bench top for a manually timed development and then placed into Acucy 2 Reader to be scanned (READ NOW Mode). The Acucy 2 Reader will scan the Test Cassette and measure the absorbance intensity by processing the results using method-specific algorithms. The Acucy 2 Reader will display the test results POS (+), NEG (-), or INVALID on the screen. The results can also be automatically printed on the optional Printer if this option is selected.

The BD Veritor™ System for Rapid Detection of Flu A+B CLIA-Waived Kit is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral nucleoprotein antigens from nasal and nasopharyngeal swabs of symptomatic patients. The BD Veritor™ System for Rapid Detection of Flu A+B CLIA-Waived Kit (also referred to as the BD Veritor System and BD Veritor System Flu A+B) is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single processed sample using a single device. The test is to be used as an aid in the diagnosis of influenza A and B viral infections. A negative test is presumptive, and it is recommended that these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions. The test is not intended to detect influenza C antigens. Performance characteristics for influenza A and B were established during January through March of 2011 when influenza viruses A/2009 H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage were the predominant influenza viruses in circulation according to the Morbidity and Mortality Weekly Report from the CDC entitled "Update: Influenza Activity-United States, 2010-2011 Season, and Composition of the 2011-2012 Influenza Vaccine." Performance characteristics may vary against other emerging influenza viruses. If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to the state or local health department for testing. Virus culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

The BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral antigens from nasopharyngeal and nasal swabs of symptomatic patients. The test is to be used as an aid in the diagnosis of influenza A and B viral infections. It is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single processed sample using a single test device. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other management decisions. All negative test results should be confirmed by another methodology, such as a nucleic acid-based method. BD Veritor™ System Flu A+B test devices are interpreted by a BD Veritor™ Plus Analyzer. When using the BD Veritor™ Plus Analyzer, workflow steps depend on the selected operational mode and the Analyzer configuration settings. In Analyze Now mode, the instrument evaluates assay devices after manual timing of their development. In Walk Away mode, devices are inserted immediately after application of the specimen, and timing of assay development and analysis is automated. The BD Veritor™ System Flu A+B CLIA-Waived Kit is an immuno-chromatographic assay for detection of influenza A and B viral antigens in samples processed from respiratory specimens. The viral antigens detected by the BD Flu A+B test are nucleoprotein, not hemagglutinin (HA) or neuraminidase (NA) proteins. Flu viruses are prone to minor point mutations (i.e., antigenic drift) in either one or both of the surface proteins (i.e., HA or NA). The BD Flu A+B test is not affected by antigenic drift or shift because it detects the highly conserved nucleoprotein of the influenza viruses. To perform the test, the patient specimen swab is treated in a supplied reaction tube prefilled with a lysing agent that serves to expose the target viral antigens, and then expressed through a filter tip into the sample well on a BD Veritor"10 Flu A+B test device. Any influenza A or influenza B viral antigens present in the specimen bind to anti-influenza antibodies conjugated to colloidal gold micro-particles on the BD Veritor™ Flu A+B test strip. The antigen-conjugate complex then migrates across the test strip to the capture zone and reacts with either Anti-Flu A or Anti-Flu B antibodies that are immobilized on the two test lines on the membrane. The BD Flu A+B test device shown in Figure 1 is designed with five spatially distinct zones including positive and negative control line positions, separate test line positions for the target analytes, and a background zone. The test lines for the target analytes are labeled on the test device as 'A' for flu A position, and 'B' for flu B position. The onboard positive control ensures the sample has flowed correctly and is indicated on the test device as 'C'. Two of the five distinct zones on the test device are not labeled. These two zones are an onboard negative control line and an assay background zone. The active negative control feature in each test identifies and compensates for specimen-related, nonspecific signal generation. The remaining zone is used to measure the assay background. The BD Veritor™ Plus Analyzer is a digital immunoassay instrument that uses a reflectance-based measurement method and applies assay specific algorithms to determine the presence or absence of the target analyte. The Analyzer supports the use of different assays by reading an assay-specific barcode on the test device. Depending on the configuration chosen by the operator, the instrument communicates status and results to the operator via a liquid crystal display (LCD) on the instrument, a connected printer, or through a secure connection to the facility's information system. In the case of the Flu A + B test, the BD Veritor™ Plus Analyzer subtracts nonspecific signal at the negative control line from the signal present at both the Flu A and Flu B test lines. If the resultant line signal is above a pre-selected assay cutoff, the specimen scores as positive. If the resultant line signal is below the cutoff, the specimen scores as negative. Use of the active negative control feature allows the BD Veritor™ Plus Analyzer to correctly interpret test results that cannot be scored visually because the human eye is unable to accurately perform the subtraction of the nonspecific signal. The measurement of the assay background zone is an important factor during test interpretation as the reflectance is compared to that of the control and test zones. A background area that is white to light pink indicates the device has performed correctly.

The BD Veritor System for Rapid Detection of Flu A+B CLIA waived assay is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral nucleoprotein antigens from nasal and nasopharyngeal swabs of symptomatic patients. The BD Veritor System for Rapid Detection of Flu A+B (also referred to as the BD Veritor System and BD Veritor System Flu A+B) is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single processed sample using a single device. The test is to be used as an aid in the diagnosis of influenza A and B viral infections. A negative test is presumptive and it is recommended that these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions. The test is not intended to detect influenza C antigens.

The BD Veritor™ System for Rapid Detection of Flu A+B is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral antigens from nasopharyngeal and nasal swabs of symptomatic patients. The test is to be used as an aid in the diagnosis of influenza A and B viral infections. It is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single processed sample using a single test device. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other management decisions. All negative test results should be confirmed by another methodology, such as a nucleic acid-based method. BD Veritor™ System Flu A+B test devices are interpreted by a BD Veritor™ Plus Analyzer. When using the BD Veritor™ Plus Analyzer, workflow steps depend on the selected operational mode and the Analyzer configuration settings. In Analyze Now mode, the instrument evaluates assay devices after manual timing of their development. In Walk Away mode, devices are inserted immediately after application of the specimen, and timing of assay development and analysis is automated. Depending on the configuration chosen by the operator, the instrument communicates status and results to the operator via a liquid crystal display (LCD) on the instrument, a connected printer, or through a secure connection to the facility's information system.

The OSOM® ULTRA PLUS FLU A&B Test is an in vitro rapid diagnostic immunochromatographic assay intended for the qualitative detection of influenza type A and type B nucleoprotein antigens directly from nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. This test is not intended for the detection of influenza C viruses. A negative test result is presumptive, and it is recommended these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the US 2018-2019 influenza season when A/H1N1pdm09 and influenza A/H3N2 were the predominant influenza A viruses in circulation, and the influenza B Yamagata and Victoria lineages were in co-circulation. When other influenza A or B viruses are emerging, performance characteristics may vary. If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

The OSOM® ULTRA PLUS FLU A&B Test consists of a test stick that separately detects influenza A and B. The test procedure requires the solubilization of the nucleoproteins from a swab by mixing the swab in Extraction Buffer. The test stick is then placed in the sample mixture, which then migrates along the membrane surface. If influenza A and/or B viral antigens are present in the sample, it will form a complex with mouse monoclonal IgG antibodies to influenza A and/or B nucleoproteins conjugated to colloidal gold. The complex will then be bound by another a rat anti-influenza A and/or mouse anti-influenza B antibody coated on the nitrocellulose membrane. A pink to purple control line must appear in the control region of the stick for results to be valid. The appearance of a second and possibly a third light pink to purple line in the test line region indicates an A, B or A and B positive result. A visible control line with no test line is a negative result.

The CareStart™ Flu A&B Plus is an in vitro rapid immunochromatographic assay for the qualitative detection of influenza virus type A and B nucleoprotein antigens directly from nasopharyngeal swab specimens of symptomatic patients. The test is intended for use as an aid in the rapid differential diagnosis of acute influenza type A and B viral infections. This test is intended to distinguish between influenza type A and/or B virus in a single test. This test is not intended to detect influenza type C viral antigens. Negative test results are presumptive and should be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative results do not preclude influenza virus infections and should not be used as the basis for treatment or other patient management decisions. Performance characteristics for influenza A and B were established during the 2018-2019 influenza season when influenza A/H3N2, A/H1N1pdm09, and B/Victoria were the predominant influenza viruses in circulation. When other influenza viruses are emerging, performance characteristics may vary. If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to the state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to received and culture specimens.

The CareStart™ Flu A&B Plus test is an immunochromatographic assay for detection of extracted influenza type A and B virus nucleoprotein antigens in nasopharyngeal specimens. Nasopharyngeal swabs require a sample preparation step in which the sample is eluted and washed off into the extraction buffer solution. Extracted swab sample is added to the sample well of the test device to initiate the test. When the swab sample migrates in the test strip, influenza A or B viral antigens bind to anti-influenza antibodies conjugated to indicator particles in the test strip forming an immune complex. The immune complex is then captured by each test line and control line on the membrane as it migrates through the strip. Test results are interpreted at 10 minutes. The presence of two colored lines, a purplecolored line in the control region "C" and a red-colored line in the influenza A test region "A", indicates influenza A positive. The presence of two colored lines, a purplecolored line in the control region "C" and a blue-colored line in the influenza B test region "B", indicates influenza B positive. The presence of three colored lines, a purple-colored line in the control region "C", a red-colored line in the influenza A test region "A", and a blue-colored line in the influenza B test region "B indicates, influenza A and B dual positive result. The absence of a line on both influenza A and B test regions with a purple-colored line in the control region "C" indicates negative. No appearance of purple-colored line in the control region "C" indicates invalid test.

The Acucy™ Influenza A&B Test for the rapid qualitative detection of influenza A and B is composed of a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral nucleoprotein antigens from nasal and nasopharyngeal swabs of symptomatic patients that is automatically analyzed on the Acucy Reader. The Acucy Influenza A&B Test is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single processed sample using a single Test Cassette. The test is intended for use with the Acucy System as an aid in the diagnosis of influenza A and B viral infections. The test is not intended for the detection of influenza C viruses. Negative test results are presumptive and should be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions.

The Acucy™ Influenza A&B Test is a lateral flow immunochromatographic assay in the sandwich immunoassay format. The Acucy Influenza A&B Test consists of a Test Cassette that detects and differentiates influenza A and influenza B viral antigens from a patient sample. The test sample, a nasal swab or nasopharyngeal swab, is processed to extract nucleoproteins by mixing the swab in Acucy Influenza A&B Extraction Buffer. The mixture is then added to the sample well of the Test Cassette. From there, the sample migrates along the membrane surface. If influenza A or B viral antigens are present, they form a complex with mouse monoclonal antibodies to influenza A and/or B nucleoproteins conjugated to colloidal gold. The complex is then bound by a rat anti-influenza A and/or mouse anti-influenza B antibody coated on the nitrocellulose membrane. The Acucy Reader is an optoelectronic instrument that uses a reflectance-based measurement method to evaluate the line signal intensities in the results window of the Test Cassette. The Reader scans the Test Cassette and measures the absorbance intensity by processing the results using method-specific algorithms. The Acucy Reader displays the test results POS (+), NEG (-), or INVALID on the screen. The results can also be automatically printed on the Acucy Printer if this option is selected.

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The Alere BinaxNOW Influenza A & B Card 2 is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab and nasal swab specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions. Alere BinaxNOW Influenza A & B Card 2 must be read by the Alere Reader. Performance characteristics for influenza A were established during the 2015-2016 influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

The Alere BinaxNOW® Influenza A & B Card 2 is an immunochromatographic membrane assay that detects influenza type A and B nucleoprotein antigens in respiratory specimens. Influenza specific antibodies and a control antibody are immobilized onto a membrane support as three distinct lines and combined with other reagents/pads to construct a test strip. The test strip is mounted inside a cardboard, book-shaped hinged test card. Swab specimens require a sample preparation step, in which the sample is eluted off the swab into Elution Solution. Sample is added to the top of the test card is closed. Test results are interpreted at 15 minutes based on the presence or absence of Sample Lines. Alere BinaxNOW® Influenza A & B Card 2 test results must be read by the Alere™ Reader. The Alere™ Reader is an easy to use bench top instrument that can be used near patient and in laboratory settings which will interpret, capture and transmit test results. The Alere™ Reader is a camera based instrument that detects the presence and identity of the Alere BinaxNOW® Influenza A& B Card 2 assay, analyzes the intensity of the test and control lines and displays the results (positive, neqative or invalid) on a display screen. The screen is intended as a means of user interface informing the user how to operate the Reader and to display test results, including any errors. Data can be retrieved and downloaded by the operator at any time after testing and uploaded to the hospital LIS/LIM system, if desired. Operator ID and Subject ID can be entered manually or via the provided barcode scanner. An external printer can be attached via USB to the Alere™ Reader to print test results.

The BD Veritor System for Rapid Detection of Flu A+B is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral nucleoprotein antigens from nasal and nasopharyngeal swabs of symptomatic patients. The BD Veritor System for Rapid Detection of Flu A+B (also referred to as the BD Veritor System and BD Veritor System Flu A+B) is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single processed sample using a single device. The test is to be used as an aid in the diagnosis of influenza A and B viral infections. A negative test is presumptive and it is recommended that these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Outside the U.S., a negative test is presumptive and it is recommended that these results be confirmed by viral culture or a molecular assay cleared for diagnostic use in the country of use. FDA has not cleared this device for use outside of the U.S. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions. The test is not intended to detect influenza C antigens.

The BD Veritor System for Rapid Detection of Flu A+B is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral antigens from nasopharyngeal and nasal swabs of symptomatic patients. The test is to be used as an aid in the diagnosis of influenza A and B viral infections. It is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single processed sample using a single test device. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other management decisions. All negative test results should be confirmed by another methodology, such as a nucleic acid based method. All BD Veritor System Flu A+B test devices are interpreted by a BD Veritor System Instrument, either a BD Veritor Reader or BD Veritor Plus Analyzer. The BD Veritor Flu A+B test is an immuno-chromatographic assay for detection of influenza A and B viral antigens in samples processed from respiratory specimens. The viral antigens detected by the BD Flu A+B test are nucleoprotein, not hemagglutinin (HA) or neuraminidase (NA) proteins. Flu viruses are prone to minor point mutations (i.e., antigenic drift) in either one or both of the surface proteins (i.e., HA or NA). The BD Flu A+B test is not affected by antigenic drift or shift because it detects the highly conserved nucleoprotein of the influenza viruses 12. To perform the test, the patient specimen swab is treated in a supplied reaction tube prefilled with a lysing agent that serves to expose the target viral antigens, and then expressed through a filter tip into the sample well on a BD Veritor Flu A+B test device. Any influenza A or influenza B viral antigens present in the specimen bind to anti-influenza antibodies conjugated to colloidal gold micro-particles on the Veritor Flu A+B test strip. The antigen-coniugate complex then migrates across the test strip to the capture zone and reacts with either Anti-Flu A or Anti-Flu B antibodies that are immobilized on the two test lines on the membrane. The BD Flu A+B test device shown in Figure 1 is designed with five spatially-distinct zones including positive and negative control line positions, separate test line positions for the target analytes, and a background zone. The test lines for the target analytes are labeled on the test device as 'A' for flu A position, and 'B' for flu B position. The onboard positive control ensures the sample has flowed correctly and is indicated on the test device as 'C'. Two of the five distinct zones on the test device are not labeled. These two zones are an onboard negative control line and an assay background zone. The active negative control feature in each test identifies and compensates for specimen-related, nonspecific signal generation. The remaining zone is used to measure the assay background. The Veritor System is made up of assay kits with analyte specific reagents and an optoelectronic interpretation instrument. The BD Veritor System instruments use a reflectance-based measurement method and apply assay specific algorithms to determine the presence or absence of the target analyte. In the case of the Flu A + B test. the BD Veritor System instruments subtract nonspecific signal at the negative control line from the signal present at both the Flu A and Flu B test lines. If the resultant line signal is above a pre-selected assay cutoff, the specimen scores as positive. If the resultant line signal is below the cutoff, the specimen scores as negative. Use of the active negative control feature allows the BD Veritor System instruments to correctly interpret test results that cannot be scored visually because the human eye is unable to accurately perform the subtraction of the nonspecific signal. The measurement of the assay background zone is an important factor during test interpretation as the reflectance is compared to that of the control and test zones. A background area that is white to light pink indicates the device has performed correctly. Sample preparation is the same for use with both instruments, and both can utilize the same kit components. Neither instrument requires calibration. The Veritor Reader and the Veritor Plus Analyzer use the functional components and decision algorithm in the firmware. The BD Veritor Plus Analyzer has the flexibility of an optional bar code scanning module and cellular connectivity designed to facilitate record keeping as well as the addition of a "Walk Away" work flow mode. Depending on the configuration chosen by the operator, the Veritor Plus Analyzer communicates status and results to the operator via a liquid crystal display (LCD) on the instrument, a connected printer, or through a secure connection to the facility's information system.