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RPS Adenovirus Detector | RPS Inc.

RPS Inc.

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RPS Inc. RPS Adenovirus Detector Logo
RPS Inc. RPS Adenovirus Detector Logo
The FDA cleared and CLIA waived RPS Adeno Detector™ is the first true point of care test available for conjunctivitis. It provides a definitive result in 10 minutes and essentially makes available an accurate laboratory confirmation of adenoviral conjunctivitis at the time of the exam. The RPS Adeno Detector can aid health care providers to make an accurate diagnosis, foster patient acceptance of more supportive therapies, identify contagious viral conjunctivitis, and limit spread of disease while simultaneously reducing ocular antibiotic resistance and the cost of unnecessary antibiotics.

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*:

  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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