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RPS Adeno Detector HS for Diagnosing Adenoviral Conjunctivitis

15:34 EDT 23rd April 2014 | BioPortfolio

Summary

The RPS Adeno Detector HS will be demonstrated to be more sensitive and specific than the RPS Adeno Detectorâ„¢.

Description

To engage in a multi-center, prospective, masked clinical trial to investigate a non-invasive rapid pathogen screening test, the RPS Adeno Detector HS's ability to detect the presence of the adenovirus (ADV) antigen in cases of acute conjunctivitis by comparing it to both the RPS Adeno Detectorâ„¢ and the polymerase chain reaction (PCR).

Currently, acute conjunctivitis is primarily a clinical diagnosis. Cultures are rarely performed due to the significant time delay in receiving results. Recently, the RPS Adeno Detectorâ„¢ was both FDA cleared and CLIA waived. It is an antigen-based immunoassay that has the ability to detect the presence of ADV at the point of care. RPS Inc has made modifications to the sampling to pad and test strip to facilitate better antigen collection and release, respectively. It is believed that these changes will lead to better sensitivity, specificity, and ease of use of the test.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Conditions

Conjunctivitis

Intervention

Immunoassay

Location

Manatee Eye Clinic
Bradenton
Florida
United States
34208

Status

Completed

Source

Rapid Pathogen Screening

Results (where available)

View Results

Links

Medical and Biotech [MESH] Definitions

Conjunctivitis due to hypersensitivity to various allergens.

A highly contagious disease characterized by subconjunctival hemorrhage, sudden swelling of the eyelids and congestion, redness, and pain in the eye. Epidemic conjunctivitis caused by Enterovirus 70 (EV-70) was first described in Africa in 1969. It is caused also by Coxsackievirus A24 variant (CA24v). Epidemics by this organism have appeared most frequently in Asia.

An infection of the eyes characterized by the presence in conjunctival epithelial cells of inclusion bodies indistinguishable from those of trachoma. It is acquired by infants during birth and by adults from swimming pools. The etiological agent is CHLAMYDIA TRACHOMATIS whose natural habitat appears to be the genito-urinary tract. Inclusion conjunctivitis is a less severe disease than trachoma and usually clears up spontaneously.

An immunoenzyme test for the presence of drugs and other substances in urine and blood. The test uses enzyme linked antibodies that react only with the particular drug for which the sample is being tested.

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