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The FDA has granted 510(k) clearance to a rapid, point-of-care test (RPS Adeno Detector Plus, Rapid Pathogen Screening Inc.) to diagnose adenoviral conjunctivitis.
Sarasota, FL- The FDA has granted 510(k) clearance to a rapid, point-of-care test (RPS Adeno Detector Plus, Rapid Pathogen Screening Inc.) to diagnose adenoviral conjunctivitis.
The test can detect all known serotypes of adenoviral conjunctivitis in 10 minutes, using a small sample of human tears, according to the company, which expects the test to be categorized as a Clinical Laboratory Improvement Amendments-waived test similar to its predecessor (RPS Adeno Detector).
“Receiving FDA 510(k) clearance signifies a critical step in bringing affordable, easy-to-use diagnostics to market that will not only improve patient care but will help reduce both the spread of disease and health care costs,” said Thomas Orsini, president and chief executive officer of RPS.
Similar to its predecessor, the new test displays a single control line to indicate a negative test result and both a control line and a result line to indicate a positive result. The new test, however, displays a blue control line and, when applicable, a red positive result line to illustrate clearly negative or positive test results. The new test also has 10 times more analytical sensitivity than the first-generation test and demonstrates a clinical sensitivity of 90% and a specificity of 96% when compared against cell culture-the gold standard-as the reference method, according to the company.