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The Thermo Electron CT OIA assay is an Optical ImmunoAssay (OIA) test for the rapid, qualitative detection of chlamydial antigen from female endocervical swab specimens. This test is intended for in vitro diagnostic use as an aid in identifying the presence of Chlamydia trachomatis antigen. The assay is intended for in vitro diagnostic use with symptomatic females in populations at risk for sexually transmitted diseases. CT OIA test results are presumptive evidence for either the presence or absence of C. trachomatis. Definitive laboratory evidence for the presence/ absence of C. trachomatis would need additional testing. CT OIA test results should not preclude empiric treatment of women with overt symptoms of PID. Performance for use in asymptomatic male and female populations has not been established.

The CT OIA test involves the qualitative extraction of antigen specific to the Chlamydia genus. The Optical ImmunoAssay technology enables the direct visual detection of a physical change in the optical thickness of molecular thin films. This change is a result of antigen-antibody binding on an optical surface (silicon wafer). When an extracted specimen is placed directly on the optical surface, the immobilized specific antibodies capture the antigen. After washing, the substrate is added, increasing the thickness (mass enhancement) of the molecular thin film. This change in thickness alters the reflected light path and is visually perceived as a color change. Slight changes in optical thickness produce a distinct, visible color change. A positive result appears as a purple spot on the predominant gold background. When antigen is not present in the specimen, no binding takes place. Therefore, the optical thickness remains unchanged and the surface retains the original gold color indicating a negative result.

The Thermo BioStar® GC OIA assay is an Optical ImmunoAssay test for the rapid qualitative detection of gonococcal antigen (L7/L12 ribosomal protein) in female endocervical swab and male urine specimens. Urine specimens must be prepared using an accessory Urine Filtration Device (UFD) for concentration and extraction. This test is intended for in vitro diagnostic use as an aid in identifying the presence of Neisseria gonorrhoeae antigen. The assay is intended for use with symptomatic females and males, in populations at risk for sexually transmitted diseases.

The GC OIA test involves the qualitative extraction and detection of an antigen unique to N. gonorrhoeae. The Optical ImmunoAssay technology enables the direct visual detection of a physical change in the optical thickness of molecular thin films. This change is a result of antigen-antibody binding on an optical surface (silicon wafer). When an extracted specimen is placed directly on the optical surface, the immobilized specific antibodies capture the antibody-enzyme conjugate is then added for form an immune complex "sandwich" of immobilized antibody-sample-antibody HRP on the surface. After washing, the substrate is added, increasing the thickness (mass enhancement) of the molecular thin film. This change in thickness alters the reflected light path and is visually perceived as a color change. Slight changes in optical thickness produce a distinct, visible color change. A positive result appears as a purple spot on the predominant gold background. When antigen is not present in the specimen, no binding takes place. Therefore, the optical thickness remains unchanged and the surface retains the original gold color indicating a negative result.

The Thermo BioStar™ FLU OIA* A/B assay is an Optical ImmunoAssay test for the qualitative, rapid detection of influenza A and B viral antigens (nucleoproteins) extracted from nasal aspirate, nasopharyngeal swab, throat swab, and sputum specimens. This test is intended for in vitro diagnostic use to aid in the differential diagnosis of influenza A and B viral infections. The FLU OIA A/B test is not intended for detection of influenza C. Negative test results should be confirmed by cell culture.

The FLU OIA A/B test involves the extraction and detection of a protein antigen unique to influenza A or B (nucleoprotein). The Optical ImmunoAssay technology enables the direct visual detection of a physical change in the optical thickness of molecular thin films. This change is a result of antigen-antibody binding on an optical surface (silicon wafer). When an extracted specimen is placed directly on the optical surface, the immobilized specific antibodies capture the antigen. After washing, the substrate is added, increasing the thickness (mass enhancement) of the molecular thin film. This change in thickness alters the reflected light path and is visually perceived as a color change. Slight changes in optical thickness produce a distinct, visible color change. A positive result appears as a purple spot on the predominant gold background. When antigen is not present in the specimen, no binding takes place. Therefore, the optical thickness remains unchanged and the surface retains the original gold color indicating a negative result.

The Thermo BioStar® RSV OLA assay is an Optical ImmunoAssay test for the rapid and qualitative detection of respiratory syncytial virus (RSV) antigens (nucleoproteins) from nasal wash and nasopharyngeal swab specimens. This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in symptomatic neonatal and pediatric patients under the age of five. It is recommended that all negative test results be confirmed by cell culture.

The RSV OIA test involves the qualitative extraction and detection of protein antigens unique to RSV (nucleoprotein and fusion protein). The Optical ImmunoAssay technology enables the direct visual detection of a physical change in the optical thickness of molecular thin films. This change is a result of antigen-antibody binding on an optical surface (silicon wafer). When an extracted specimen is placed directly on the optical surface, the immobilized specific antibodies capture the antigen. After washing, the substrate is added, increasing the thickness (mass enhancement) of the molecular thin film. This change in thickness alters the reflected light path and is visually perceived as a color change. Slight changes in optical thickness produce a distinct, visible color change. A positive result appears as a purple spot on the predominant gold background. When antigen is not present in the specimen, no binding takes place. Therefore, the optical thickness remains unchanged and the original gold color indicating a negative result.

The Thermo BioStar® RSV OIA assay is an Optical ImmunoAssay (OIA) test for the qualitative, rapid detection of respiratory syncytial virus antigens (nucleoprotein) from nasal wash specimens. This test is intended for in vitro use to aid in the diagnosis of respiratory syncytial virus infections in symptomatic neonatal and pediatric patients under the age of five. It is recommended that all negative results be confirmed by cell culture.

The RSV OIA test involves the qualitative extraction and detection of protein antigens unique to RSV (nucleoprotein and fusion protein). The Optical ImmunoAssay technology enables the direct visual detection of a physical change in the optical thickness of molecular thin films. This change is a result of antigenantibody binding on an optical surface (silicon wafer). When an extracted specimen is placed directly on the optical surface, the immobilized specific antibodies capture the antigen. After washing, the substrate is added, increasing the thickness (mass enhancement) of the molecular thin film. This change in thickness alters the reflected light path and is visually perceived as a color change. Slight changes in optical thickness produce a distinct, visible color change. A positive result appears as a purple spot on the predominant gold background. When antigen is not present in the specimen, no binding takes place. Therefore, the optical thickness remains unchanged and the surface retains the original gold color indicating a negative result.

The BioStar® CdTOX A OlA assay is an Optical ImmunoAssay test for the rapid qualitative detection of Clostridium difficile Toxin A in human fecal samples from patients suspected of having Clostridium difficile associated disease (CDAD). This test is intended for in vitro diagnostic use as an aid in the diagnosis of CDAD.

The CdTOX A OIA test involves the qualitative detection of the enterctoxin (Toxin A) produced by Clostridium difficile. The Optical Immuno Assay technology enables the direction of a physical change in the optical thickness of molecular this change is a result of antigen-antibody binding on an optical surface (silicon wafer). When a sample containing Toxin A (antigen) from Clostridium difficile is placed directly on the optical surface, the immobilized specific antibody captures the antigen. After washing, the substrate is added, increasing the thickness (Mass Enhancement) of the molecular thin film. This change in thickness alters the reflected light path and is visually perceived as a color changes in optical thickness produce a distinct, visible color change. A positive result appears as a purple spot on the predominant gold background. When antigen is not present in the specimen, no binding takes place. Therefore, the optical thickness remains unchanged and the surface retains the original gold color indicating a negative result.

The BioStar® STREP B OIA® assay is an Optical ImmunoAssay (OIA) test for the rapid detection of group B streptococcal antigen directly from cervical and vaginal swabs from intrapartum maternity patients. The STREP B OIA assay is intended for use as an adjunct to culture, clinical observation and other information available to the physician.

The STREP B OlA test involves the extraction of a carbohydrate antigen unique to group B Streptococi from the cervical or vaginal swab specimen and the subsequent use of Optical ImmunoAssay technology for the qualitative detection of this specific antigen. The Optical ImmunoAssay technology allows the direct visual detection of the physical change in optical thickness of molecular thing from the binding reactions between antibodies and antigens. The signal is generated by the reflection of light through the molecular thin films formed on an optical substrate. White light reflected through the molecular thin film results in a predominant visual background gold color. This color will not change unless the thickness of the optical molecular thin film is changed. When a liquid sample containing antigen from group B Streptococci is placed on the test surface, binding occurs between the antigen and immobilized antibody, causing an increased thickness in the molecular this reaction takes place, the optical path through the film is changed, causing a corresponding change in the gold color to purple/blue, thereby indicating a positive result. The change in optical thickness is due to the binding of specific antigen. If the antigen is not present in the sample, no binding takes place. The original molecular thickness remains unchanged and the test surface retains its original gold color, indicating a negative result. The clear endpoint and unequivocal results observed with the optical detection system lead to a very sensitive easily interpreted assay system.

The BioStar® AB FLU OIA® assay is an Optical ImmunoAssay (OIA) test for the qualitative, rapid detection of influenza A and B viral antigen (nucleoprotein) from nasal aspirate, nasopharyngeal swab, throat swab, or sputum specimens. This test is intended for in vitro diagnostic use to aid in the diagnosis of influenza A and B viral infections. The AB FLU OIA test is not intended to detect influenza C. Negative test results should be confirmed by cell culture.

The AB FLU OIA test involves the extraction and detection of a protein antigen unique to influenza A or B (nucleoprotein). The Opical ImmunoAssay technology enables the direction of a physical change in the optical thickness of molecular thin films. This change is a result of antigen-antibody binding on an optical surface (silicon wafer). When extracted specimen is placed directly on the optical surface, the immobilized specific antibodies capture the antigen. After washing, the substrate is added, increasing the thickness (Mass Enhancement) of the molecular thin film. This change in thickness alters the reflected light path and is visually perceived as a color change. Slight changes in optical thickness produce a distinct visible color change. A positive result appears as a purple spot on the predominant gold background. When antigen is not present in the specimen, no binding takes place. Therefore, the optical thickness remains unchanged and the original gold indicating a negative result.

The BioStar® STREP A OIA® MAX assay is for the qualitative detection of Group A Streptococcal antigen directly from throat swabs. This test is intended for in vitro diagnostic use to rapidly identify Group A Streptococci in throat swab specimens from patients with suspected Group A streptococci-associated pharyngitis as an aid in the diagnosis of streptococcal infection.

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