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TRU RSV is a rapid, qualitative, lateral-flow immunoassay for the detection of Respiratory Syncytial Virus (RSV) antigens (fusion protein or nucleoprotein) in human nasal wash, nasopharyngeal aspirate, and nasal and nasopharyngeal swab samples. It is designed to test specimens from symptomatic patients aged 5 years or less. A negative result does not preclude RSV infection. It is recommended that all negative test results be confirmed by cell culture.

TRU RSV is a rapid, single-use, qualitative lateral-flow immunoassay screening test. The test kit includes a Test Strip attached to a plastic frame or holder, a Conjugate Tube containing a lyophilized bead of colloidal gold-linked monoclonal antibodies to RSV fusion protein and nucleoprotein, Sample Diluent/Negative Control, and plastic transfer pipettes. The Test Strip carries a nitrocellulose membrane with dried capture antibodies. The holder caps the Conjugate Tube during testing and disposal. The conjugate bead is rehydrated with Sample Diluent, sample is added and mixed, and the Test Strip is inserted. If RSV antigens are present, they bind to the conjugate and are captured at the Test Line, forming a pink-red line. An internal control line indicates proper flow.

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.