Rapid Pathogen Screening, Inc.'s (South Williamsport, Pa.) RPS Adeno Detector has been approved for the visual, qualitative detection of adenovirus antigens in human eye fluid. The point-of-care rapid immunochromatography test is indicated as an aid in the differential diagnosis of acute adenoviral conjunctivitis. The test is performed by collecting tear fluid on an absorbent strip that is dipped in a buffering solution. If present, the adenovirus antigen is captured between two antigen-specific antibodies.

Results are available within 10 minutes, read as 1 (negative) or 2 (positive) red lines in the read-out area. The test is best used within 7 days of developing red eye consistent with infectious conjunctivitis.

The test demonstrated a sensitivity of 88% and specificity of 91% for adenovirus. False-positive results were obtained for three of 12 culture-negative samples.

The availability of rapid test results is expected to decrease the use of unnecessary antibiotic therapy and to reduce the risk of transmission of contagious viral conjunctivitis.

For more information, visit http://www.fda.gov/cdrh/pdf5/K052092.pdf.