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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 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 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.

The OSOM® Mono Test is intended for the qualitative detection of infectious monomucleosis heterophile antibodies in serum, plasma or whole blood as an aid in the diagnosis of infectious mononucleosis.

The OSOM Mono Test uses color immunochromatographic dipstick technology with bovine erythrocyte extract coated on the membrane. In the test procedure, serum, plasma or whole blood is mixed with the Diluent. Then the Test Stick is placed in the mixture migrates along the membrane. If the specific IM heterophile antibody is present in the sample, it will form a complex with the bovine erythrocyte extract conjugated color particles. The complex will then be bound by bovine erythrocyte xtract immobilized on the membrane and a visible blue Test Line will appear to indicate a positive result.

The OSOM iFOB (Immunochemical Fecal Occult Blood) Test is a rapid immunoassay for the qualitative detection of fecal occult blood by laboratories or physicians' offices. It is useful for the detection of human hemoglobin in human fecal samples and is recommended for use as part of routine physical examinations or when lower gastrointestinal disorders are suspected.

The OSOM iFOB (Immunochemical Fecal Occult Blood) Test is a rapid test which can detect the presence of occult blood in human fecal samples by detecting the presence of human hemoglobin (hHb). The OSOM iFOB Test is a qualitative assay that employs immuochromatographic, lateral flow technology. A test kit contains 25 pouched Test Devices, 25 Extraction Reagent vials, 25 conjugate vial tips, and 25 sample collection packs. Tests and Reagents are also available in a 50-test kit without sample collection packs, and sample collection packs are available separately in a package of 50. Negative and positive external controls are provided separately as the OSOM iFOBT Control Kit. The fecal sample collected using an OSOM iFOB sample collection card is placed into a prefilled vial containing Extraction Buffer. This test solution is then dispensed, through a dropper tip containing human hemoglobin antibody conjugated to latex, into the sample well of the Test Device. The sample migrates across the membrane containing a Test line coated with anti-human hemoglobin antibody and a Control line. If hemoglobin is present at or above the level of detection of the test, an antigen/antibody complex will be formed. The appearance of a visible blue Test line and a red Control line in the result window indicates the presence of human hemoglobin in the sample. A red control line must appear for the results to be valid. If a detectable level of hemoglobin is not present, only the red control line will appear. An invalid test occurs when no control line appears. The control line serves as an internal procedural control, indicating that the test system is functioning correctly and that the operator added a sufficient volume of sample. In addition to the internal control in each Test Device, external controls are available in a separate OSOM iFOBT Control Kit. The Negative Control (buffer solution) and the Positive Control (hHb in buffer solution) are run in the iFOB Test in the same manner as an extracted fecal sample.

The OSOM® Influenza A&B Test is an in vitro diagnostic immunochromatographic assay intended for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal swab specimens in symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and/or B viral infections. This test is not intended for the detection of influenza C viruses. A negative test is presumptive and it is recommended these 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 OSOM® Influenza 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 mouse anti-influenza A and/or 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 will appear in the test line region indicating an A, B or A and B positive result.