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An improved version of a first-point-of-care diagnostic test for conjunctivitis (AdenoPlus, Rapid Pathogen Screening [RPS]) has been granted waived status by the FDA under the Clinical Laboratory Improvement Amendments (CLIA).
Sarasota, FL-An improved version of a first-point-of-care diagnostic test for conjunctivitis (AdenoPlus, Rapid Pathogen Screening [RPS]) has been granted waived status by the FDA under the Clinical Laboratory Improvement Amendments (CLIA).
The CLIA waiver, in addition to the FDA 510(k) clearance previously received, allows the test to be used in the United States. The waiver classifies the test as a low-complexity device, which allows the test to be administered by medical office personnel.
The proprietary test allows for the rapid detection of adenoviral antigens directly from tears obtained from the inside of the lower conjunctiva, according to the company. A nurse or technician can perform the test when a patient presents with a red eye or other symptoms of conjunctivitis. The patient can then be isolated for 10 minutes while awaiting the results.
According to RPS, the improved test has a clinical sensitivity of 90% and a specificity of 96% when compared with cell culture as the reference method. The test’s accuracy allows for the appropriate patient management to begin at the office visit and reduces future unnecessary medical office visits, the cost of unnecessary antibiotic prescriptions, and the need for additional laboratory testing, according to the company.
“The clinical signs and symptoms of adenoviral and bacterial conjunctivitis are nonspecific, making it very challenging to diagnose clinically,” said Robert Sambursky, MD, RPS president and chief medical officer. “[This improved test] provides an accurate adenovirus diagnosis in 10 minutes, positioning this test in the same category with other rapid and routinely used in-office diagnostic tools, such as strep and flu tests.”
RPS anticipates that the test will be available in the United States by early August.
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