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The RPS Adeno Detector Plus is a rapid immunoassay test for the visual, qualitative in vitro detection of Adenoviral antigens (hexon protein) directly from human eye fluid. The test is intended for professional use as an aid in the rapid differential diagnosis of acute conjunctivitis. Negative results do not preclude Adenovirus infection nor are thev intended to rule out other microbial-caused infections of the conjunctiva. and should not be used as the sole basis for treatment or other management decisions.

The RPS Adeno Detector Plus™ consists of three (3) parts: a Sample Collector, an immunoassay test strip in a plastic Test Cassette housing, and a Buffer. The Sample Collector is used to take a sample of ocular fluid. The separately packaged and sterile Sample Collector has a contoured end with a Dacron fleece to collect the samples. The plastic housing of the Test Cassette body protects the strip from unintended physical influence. Additionally the housing guarantees correct sample transfer onto the lateral flow assay strip. The Buffer is a buffered salt solution containing proteins, detergents and preservatives. The Buffer functions as the solution that initiates the test, extracts the Adenoviral proteins, filters unwanted cellular debris, and transports the immune complex and the control conjugate to the Test and Control Lines on the test strip membrane. Mechanism of action - RPS Adeno Detector Plus™ is based on the principle of lateral flow immunoassays using Direct Sampling Micro-filtration technology. Viral particles or virus antigens are captured by an antigen specific antibody. A single monoclonal antibody highly specific to the Adenoviral hexon protein is labeled with colloidal gold and also is immobilized as the Test Line.

The RPS Adeno Detector is a rapid immunochromatography test for visual, qualitative in-vitro detection of adenoviral antigens (hexon protein) directly from human eye fluid. The test is intended for use as an aid in the rapid differential diagnosis of acute adenoviral conjunctivitis. All negative test results should be confirmed by cell culture.

The RPS Adeno Detector utilizes technology based on lateral flow immunochromatography. Adenoviral antigen, hexon protein, when present in the patient sample is captured between two antigen specific antibodies. One antibody is immobilized in the detection zone of the device. The second antibody is labeled with colloidal gold. The detector is a disposable, rapid test requiring 10 minutes for a result. The patient's lower eyelid is gently retracted to expose the inferior fornix. The eye fluid is collected on the sterile sample collector by gently swabbing the inferior fornix with the sampling pad on the test cover to gain a sample of tears for point of care analysis. The sample collector is reassembled to the immunoassay cassette. Sample transfer happens automatically. Analysis of the sample starts when the absorbant pad of the strip is dipped into a provided buffering solution. After 1-10 minutes, red colored lines in the read out area will appear. One line (control line) only indicates a (Adenoviral) negative result, where as two lines (control line and test line) indicate a (Adenoviral) positive result. It is best used within 7 days of developing a red eye consistent with infectious conjunctivitis.

The SASTM Adeno Test is a membrane-based immunogold assay for the detection of adenovirus and adenovirus antigens. The test is a rapid visual test for the qualitative detection of adenovirus serotypes present in eye swabs, nasal and pharyngeal secretions, fecal samples, and cell culture supernatant. This test is for professional use only.

membrane-based immunogold assay

The Adenovirus Antigen Detection ELISA Test System is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of Adenovirus antigen in human fecal samples as an aid in the diagnosis of acute non-bacterial gastro-enteritis. Performance for this assay has not been established on children over the age of five and immunocompromised patients. The antibody utilized in this assay is a group specific antigen and cannot differentiate between types of adenovirus. Performance of this assay has not been established for specimens other than human feces. For in vitro diagnostic use only.

The Adenovirus Antigen Detection ELISA test is an enzyme linked immunosorbent assay to detect adenovirus antigen in fecal samples. Purified monoclonal antibody specific to adenovirus is attached to a solid phase microtiter well. Diluted fecal sample is added to each well. If the adenovirus antigen is present, it will bind to the monoclonal antibody in the well. After incubation the wells are washed to remove unbound antigen. An enzyme labeled anti-adenovirus polyclonal antibody is added to each well. If antigen is present the conjugate antibody will bind to the antigen attached to the antibody on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.