Influenza A Typing Real-Time PCR Test CE

The Aridia Influenza A Typing Real-Time PCR Test is based on the real-time amplification and detection of influenza A subtypes H1N1 (pdm09), H3N2, H5N1, and H7N9 in a one-step format.

The test is designed for specific and qualitative detection and differentiation of influenza A subtypes H1N1 (pdm09), H3N2, H5N1, and H7N9 in influenza A virus-positive clinical specimens as an aid in the diagnosis of influenza A 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.

Recommended for use:

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.

This test should be used with specimens positive for Influenza A viral RNA, which is detectable in clinical respiratory specimens within the first 5 days after illness onset. A positive PCR test is confirmatory of influenza A subtype H1N1 (pdm09), H3N2, H5N1, and/or H7N9 infection. A negative PCR test does not preclude infection with influenza A subtypes H1N1 (pdm09), H3N2, H5N1, and/or H7N9 and should not be used as the sole basis for patient management decisions. 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.

  • Sensitivity: 96.5% for H1N1 (pdm09), 97.1% for H3N2
  • Specificity: 97.6% for H1N1 (pdm09), 100% for H3N2
  • Limit of Detection: The kit has a detection limit of ≥50 influenza A subtype H1N1 (pdm09), ≥50 influenza A subtype H3N2, ≥10 influenza A subtype H5N1, and ≥10 influenza A subtype H7N9 RNA copies per reaction.
  • Cross-Reactivity: no cross-reactivity with many common respiratory pathogens (see details in package insert)
  • Influenza A Typing Real-Time RCR Test Strips
  • H5N1/H7N9 Confirmatory Test Strips
  • Optical Caps
  • Positive Control
  • Negative Control
  • PCR-Grade Water
  • Resuspension Solution

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Influenza A Typing Real-Time PCR Test


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