An influenza virus antigen detection test system is a device that detects the presence of influenza virus proteins in respiratory samples. These tests are also known as rapid influenza diagnostic tests (RIDTs).

 Intended Use of Influenza Virus Antigen Detection Test System

 An Influenza Virus Antigen Detection Test System is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection. The test aids in the diagnosis of influenza infection and provides epidemiological information on influenza. Due to the propensity of the virus to mutate, new strains emerge over time which may potentially affect the performance of these devices. Because influenza is highly contagious and may lead to an acute respiratory tract infection causing severe illness and even death, the accuracy of these devices has serious public health implications.

Intended use.

The device is an in vitro diagnostic immunological test system intended for the qualitative detection of influenza A and influenza B viral antigens in human respiratory specimens (such as nasal swabs, nasopharyngeal swabs, or nasal aspirates). The test is used as an aid in the diagnosis of influenza A and influenza B viral infections. The System for Rapid Detection of Flu A+B CLIA-Waived Kit is a rapid chromatographic immunoassay for detecting influenza A and B viral nucleoprotein antigens from symptomatic patients’ nasal and nasopharyngeal swabs. It differentiates between influenza A and B viral antigens from a single sample, aiding in the diagnosis of viral infections. Negative results should be confirmed by viral culture or FDA-cleared molecular assay.

Device Description:

The test is an immunochromatographic assay used to detect influenza type A and B virus nucleoprotein antigens in nasopharyngeal specimens. The sample is eluted and washed off into the extraction buffer solution, then added to the test device. The sample migrates through the test strip, forming an immune complex with anti-influenza antibodies. The immune complex is captured by each test line and control line on the membrane. Results are interpreted at 10 minutes. Positive results show two colored lines in the control region, red lines in the A test region, and blue lines in the B test region. A dual positive result indicates a positive result. Negative results show no purple-colored line in the control region, and invalid results have no purple-colored line.

• Kit contains the following components:
• Test Sticks
• Sterile Nasal Swabs
• Extraction Buffer vials
• Influenza A Positive Control Swab
• Influenza B Positive Control Swab
• Instructions for Use (IFU)
• Quick Reference Guide (QRG)
• Workstation

Performance Testing (Analytical-nonclinical) for Influenza Virus Antigen Detection Test System

• Precision/Reproducibility
• Detection studies- Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ)
• Linearity/assay reportable range
• Analytical specificity
• Traceability (controls, calibrators, or method)
• Analytical Sensitivity
• Analytical Specificity (Cross Reactivity)
• Interfering Substances
• Hook (Prozone) Effect
• Stability Studies

Clinical Testing: Required for 510k submission.