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The Alere™ i Influenza A & B assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2012-2013 influenza season when influenza A/H3 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.

Alere™ i Influenza A & B is a rapid, instrument-based isothermal test for the qualitative detection and differentiation of influenza A and influenza B from nasal swab specimens collected from patients presenting with signs and symptoms of respiratory infection. The Alere™ i Influenza A & B System utilizes isothermal nucleic acid amplification technology and is comprised of: - Sample Receiver single use, disposable containing the elution buffer . - . Test Base - single use, disposable comprising two sealed reaction tubes, each containing a lyophilized pellet - Transfer Cartridge single use, disposable for transfer of the eluted sample to the Test Base, and . - Alere™ i Instrument repeat use reader . The reaction tubes in the Test Base contain the reagents required for amplification of the target nucleic acid and an internal control. Alere™ i Influenza A & B utilizes a pair of templates (similar to primers) for the specific amplification of RNA from influenza A and B and a fluorescently labeled molecular beacon designed to specifically identify the amplified RNA targets. Alere™ i Influenza A & B is performed within the confinement of the Test Base, and no other part of the Alere™ i Instrument has contact with the sample during the amplification process. This minimizes the risk of instrument contamination and sample carryover between measurements. To perform the assay, the Sample Receiver and Test Base are inserted into the Alere™ i Instrument and the elution buffer is automatically the instrument. The sample is added to the Sample Receiver and transferred via the Transfer Cartridge to the Test Base, resuspending the lyophilized pellet contained within the Test Base and initiating target amplification. Heating, mixing and detection by fluorescence is provided by the instrument, with results automatically reported. Results are displayed by the Alere™ i Instrument separately for influenza A and influenza B. Results are also stored in an on-board archive and are assigned to a sample ID that has been entered into the Alere™ i Instrument by the operator, and the date/time the test was performed. Data can be retrieved and downloaded by the operator at any time after testing. An external Alere™ Universal Printer can be attached via USB to the Alere™ i Instrument to print test results.

The Alere™ Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasal swab specimens collected from symptomatic patients. 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.

The Alere™ Influenza A & B Test is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A and B nucleoprotein antigens in nasal swab specimens. These antibodies and a control protein are immobilized onto a membrane support as three distinct lines and are combined with other reagents/pads to construct a Test Strip. Nasal swab samples are added to a Coated Reaction Tube to which an extraction reagent has been added. An Alere™ Influenza A & B Test Strip is then placed in the Coated Reaction Tube holding the extracted liquid sample. Test results are interpreted at 10 minutes based on the presence of pink-to-purple colored Sample Lines. The yellow Control Line turns blue in a valid test.

The Alere BinaxNOW® Influenza A & B Card is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab, nasal swab, and nasal wash/aspirate 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. Caution: Assay sensitivity for nasal wash/aspirate samples was determined primarily using archived specimens. Users may wish to establish the sensitivity of these specimens on fresh samples.

The Alere BinaxNOW® Influenza A & B Card is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A and B nucleoprotein antigens in respiratory specimens. These 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. This 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, saline or transport media. Nasal wash/aspirate samples require no preparation. Sample is added to the top of the test strip and the test card is closed. Test results are interpreted at 15 minutes based on the presence or absence of pink-to-purple colored Sample Lines. The blue Control Line turns pink in a valid assay.

The Clearview® Exact II Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasal swab specimens collected from symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. It is recommended that negative test results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.

The Clearview Exact II Influenza A & B Test is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A and B nucleoprotein antigens in respiratory swab specimens. These antibodies and a control protein are immobilized onto a membrane support as three distinct lines and are combined with other reagents/pads to construct a Test Strip. Nasal swab samples are added to a Coated Reaction Tube to which an extraction reagent has been added. A Clearview Exact II Influenza A & B Test Strip is then placed in the Coated Reaction Tube holding the extracted liquid sample. Test results are interpreted at 10 minutes based on the presence or absence of pink-to-purcle colored Sample Lines. The yellow Control Line turns blue in a valid test.

The BinaxNOW® PBP2a Test is a qualitative, in vitro immunochromatographic assay for the rapid detection of penicillin-binding protein 2a (PBP2a) present in methicillinresistant Staphylococcus aureus (MRSA). The test is performed directly on blood culture samples positive for S. aureus. The BinaxNOW® PBP2a Test is not intended to diagnose MRSA nor to guide or monitor treatment for MRSA infections. Subculturing positive blood cultures is necessary to recover organisms for susceptibility testing or epidemiological typing.

The BinaxNOW® PBP2a Test is a rapid immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect the PBP2a protein directly from blood cultures which have been identified as being positive for S. aureus. These antibodies and a control antibody are immobilized onto a test strip as two distinct lines and combined with other reagents/pads. This test strip is mounted inside a cardboard, book-shaped hinged test device. Specimens are aliquots from blood cultures which have been identified as positive for Staphylococcus aureus. After the sample is prepared, it is added to the sample pad at the top of the test strip and the device is closed. Results are read at 10 minutes.

The Clearview® Exact PBP2a Test is a qualitative, in vitro immunochromatographic assay for the detection of penicillin-binding protein 2a (PBP2a) in isolates identified as Staphylococcus aureus, as an aid in detecting methicillin-resistant Staphylococcus aureus (MRSA). The Clearview® Exact PBP2a Test is not intended to diagnose MRSA nor to guide or monitor treatment for MRSA infections.

The Clearview® Exact PBP2a Test is a rapid immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect the PBP2a protein directly from bacterial isolates. These antibodies and a control antibody are immobilized onto a nitrocellulose membrane as two distinct lines and combined with a sample pad, a blue conjugate pad, and an absorption pad to form a test strip. Isolates are sampled directly from the culture plate and eluted into an assay tube containing Reagent 1. Reagent 2 is then added and the dipstick is placed in the assay tube. Results are read visually at 5 minutes.

The BinaxNOW® Staphylococcus aureus Test is a qualitative, in vitro immunochromatographic assay for the presumptive identification of Staphylococcus aureus. The test is performed directly on blood culture samples positive for Gram-positive cocci in clusters. The BinaxNOW® Staphylococcus aureus Test is not intended to diagnose Staphylococcus aureus nor to guide or monitor treatment for Staphylococcus aureus infections. Subculturing positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.

The BinaxNOW" Staphylococcus aureus Test is a rapid immunochromatographic membrane assay that uses highly sensitive polyclonal antibodies to detect a Staphylococcus aureus specific protein directly from blood cultures which have been identified as being positive for Gram-positive cocci in clusters. These antibodies and a control antibody are immobilized onto a test strip as two distinct lines and combined with other reagents/pads. This test strip is mounted inside a cardboard, book-shaped hinged test device. Specimens are aliquots from blood cultures which have been identified as positive for Gram-positive cocci in clusters. After the sample is prepared, it is added to the sample pad at the top of the test strip and the device is closed. Results are read at 10 minutes.

The Clearview Advanced™ Strep A test is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens as an aid in the diagnosis of Group A Streptococcal infection.

The Clearview Advanced™ Strep A test is a qualitative, lateral flow immunoassay for the detection of Strep A carbohydrate antigen directly from a throat swab sample. To perform the test, Reagent 1 (R1) is added to the extraction tube which is coated with a mixture of conjugate antibodies and a lytic enzyme extraction reagent. The lytic enzyme is mixed with colloidal gold conjugated to rabbit anti-Strep A and a second colloidal gold control coniugate antibody. The reagents are dried onto the bottom of an extraction tube forming a red spot. The extraction/conjugate pellet is resuspended with R1 and the throat swab is added to the extraction tube. The Strep A antigen is extracted from the sample and the swab is removed. The test strip is immediately placed in the extracted sample. If Group A Streptococcus is present in the sample, it will react with the anti-Strep A antibody conjugated to the gold particle. The complex will then be bound by the anti-Strep A capture antibody and a visible red test line will appear, indicating a positive result. To serve as an onboard procedural control, the blue line observed at the control site prior to running the assay will turn red, indicating that the test has been performed properly. If Strep A antigen is not present, or present at very low levels, only a red control line will appear. If the red control line does not appear, or remains blue, the test result is invalid.

The BinaxNOW® Malaria Positive Control is intended for use as an assayed positive external quality control with the qualitative BinaxNOW® Malain Test. It is designed for routine external quality control with the qualitative BinaxNOV® Malaina Test. It is designed for routi proper of the qualitative BinaxNOW "Malana" rest. It is designed for routine use to aid in wisition Test.

The BinaxNOW® Malaria Positive Control is a recombinant antigen control containing a mixture of HRP II (histidine-rich protein II), which is specific for Plasmodium falciparum (P.f.), and a pan-malarial antigen (aldolase), which is common to P.f., P. vivax, P. ovale, and P. malariae. The BinaxNOW® Malaria Positive Control can be used as a quality control sample representative of a positive test result and to verify proper performance of the procedure and reagents of the BinaxNOW® Malaria test, when it is used in accordance with the BinaxNOW® Malaria test product insert. The BinaxNOW® Malaria Positive Control is supplied lyophilized and is reconstituted using deionized water. The reconstituted control is then added to a pool of presumed negative EDTA human whole blood for use in the BinaxNOW® Malaria Test. When run on the BinaxNOW® Malaria Test, the positive control should always generate positive results on both the P.f.specific (HRP II) test line and on the pan malarial test line. This demonstrates that the test reagents are working properly and the operator performed the test procedure correctly.

The BinaxNOW® Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab, nasal swab, and nasal wash/aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results should be confirmed by cell culture.

The BinaxNOW* Influenza A & B Test is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A & B nucleoprotein antigens in nasopharyngeal (NP) swab, nasal swab, and nasal wash/aspirate specimens. These 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. This test strip is mounted inside a cardboard, book-shaped hinged test device. Swab specimens require a sample preparation step, in which the sample is eluted off the swab into elution solution or transport media. Nasal wash/aspirate samples require no preparation. Sample is added to the top of the test strip and the test device is closed. Test results are interpreted at 15 minutes based on the presence or absence of pink-to-purple colored Sample Lines. The blue Control Line turns pink in a valid assay.