Influenza A/B & RSV Real-Time PCR Test CE | CTK-P00187

The Aridia Influenza A/B & RSV Real-Time PCR Test is based on the real-time amplification and detection of influenza A, influenza B, and respiratory syncytial virus (RSV) in a one-step format.

The test is designed for specific and qualitative detection and differentiation of influenza A, influenza B, and respiratory syncytial virus (RSV) RNA in clinical respiratory specimens as an aid in the diagnosis of influenza A, influenza B, and RSV infections alongside all available clinical and epidemiological data, patient history, and other laboratory test outcomes. The product is intended for use by professionals specifically trained in nucleic acid amplification techniques and in vitro diagnostic procedures.

Any person presenting an upper respiratory tract infection that produces symptoms such as sudden onset fever, myalgia, headache, malaise, cough, sore throat, and runny nose, within a week after symptom onset.

Influenza A, influenza B, and RSV RNA is detectable in clinical respiratory specimens within the first 5 days after illness onset. A positive PCR test during this detection window is confirmatory of infection. A negative PCR test does not exclude infection and should be followed up with additional serological diagnostic testing. All test results should be evaluated by a health care professional in the context of clinical symptoms, epidemiological information, patient history, and other diagnostic test results.