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Intended Use
The RPS Adeno Detector is a rapid immunochromatographic 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.
Specifications
Target pathogen: Adenovirus, all subtypes
Lower Detection Limits:
0.1 ng of Hexon (major immunogenic part of the Adenovirus) 500 Adenovirus particles

Clinical performance*:
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Adeno Detector |
Cell Culture |
| Sensitivity: |
89% |
92% |
| Specificity: |
93% |
100% |
| Overall agreement: |
93% |
98% |
| Positive predictive value: |
82% |
100% |
| Negative predictive value: |
96% |
98% |
* measured in a blinded, multi center study in 4 hospitals, 'gold standard' was cell culture, cell culture showed a sensitivity of 92, a specificity of 100 and a total agreement 98 %, discrepant results were tested with PCR as a referee, out of the 12 culture negative and RPS positive samples 3 were found to be PCR positive.
Interferences with other pathogens:
No interferences with commonly known infections pathogens of the human eye were measured, please see package insert for details
Interferences with eye medications:
No interferences with commonly used eye medications were found, please see package insert for details
| Weight: |
15 g |
| Time to result: |
10 minutes |
| Shelf life: |
18 months |
| Storage Conditions: |
39°F to 86°F |
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