Specific Novel Influenza A Viruses

Reagents for detecting specific novel influenza A viruses are devices that use nucleic acid amplification tests to identify specific virus RNA in viral cultures or human respiratory samples. These reagents are used to diagnose influenza caused by specific novel influenza A viruses in patients who are at risk of infection. They can also be used to identify specific novel influenza A viruses in a laboratory for epidemiological purposes.

They are largely based on nucleic acid amplification tests. The DFA test and immunofluorescent antibody test (IFA) are common antigen-based tests used for the diagnosis of influenza virus infections. New methods such as real-time PCR and conventional RT-PCR assays have also been developed for the detection of novel influenza A H1N1 viruses.

Reagents for detection of specific novel influenza A viruses are devices that are intended for use in a nucleic acid amplification test to directly detect specific virus RNA in human respiratory specimens or viral cultures. Detection of specific virus RNA aids in the diagnosis of influenza caused by specific novel influenza A viruses in patients with clinical risk of infection with these viruses and also aids in the presumptive laboratory identification of specific novel influenza A viruses to provide epidemiological information on influenza. These reagents include primers, probes, and specific influenza A virus controls

Intended Use: The JBAIDS Influenza A/l-I (Asian lineage) Detection Kit is intended for use in real-time reverse-transcriptase polymerase chain reaction (rRT-PCR) assays on the Joint Biological Agent Identification and Diagnostic System (JBAIDS) instruments for the in vitro qualitative detection of Influenza A/H5 (Asian lineage) viral RNA in patient nasopharyngeal swab (NPS) or throat swab (TS) specimens for the presumptive laboratory identification of Influenza A/H5 (Asian lineage) virus.

Testing with the JBAIDS Influenza A/H5 (Asian lineage) Detection Kit should be in conjunction with other laboratory testing and clinical observations for the following indications:

1. Providing epidemiological information for the surveillance of human infection with Influenza AIR5 (Asian lineage) virus.
2. Identifying patients who may be infected with Influenza A/I-I (Asian lineage) virus based on clinical and epidemiological risk factors.

Device Description: The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Influenza AIH5 (Asian lineage) Detection Kit is a real-time reverse transcriptase polymerase chain reaction (rRT-PCR) test kit, which, when used with the JBAIDS instrument and software, allows the qualitative in vitro detection of Influenza A/H5 (Asian lineage) viral RNA. The kit contains two freeze-dried assays with primer and fluorescent probe sets for the detection of Influenza A/H5 (Asian lineage) viral RNA. In particular, the two assays specifically target distinct regions of the influenza A hemagglutinin gene of the highly pathogenic H5N I viruses from the Asian lineage, without detection of other influenza A virus subtypes, including the North American lineage influenza A1H5 viruses. The tests are performed using the previously FDA-cleared JBAIDS instrument and software. A human gene target assay will be used as an inhibition and extraction control.

Intended Use: The A/H5N1 Flu Test is intended for the in vitro qualitative detection of influenza A/H5N1 virus directly from symptomatic patient nasal or throat swab specimens or in viral cultures for the presumptive laboratory identification of influenza A/H5N1 virus.  Results from testing with the A/H5N1 Flu Test should be used in conjunction with other laboratory testing and clinical and epidemiological risk factors for the presumptive identification of patients infected with Influenza H5N1 virus.   A/H5N1 Flu Test is intended as a Prescription Use device.

Device description: A/H5N1 Flu Test is a rapid immunoassay that detects the presence of the influenza A/H5N1 virus from nasal swabs or throat swabs using a combination of gold-conjugated pan-reactive monoclonal anti-influenza A antibodies and recombinant proteins containing PDZ domains to selectively capture the non-structural protein 1 (NS1) from H5N1.  The PDZ proteins uniquely bind PDZ ligands (PL) through specific amino acid sequences at carboxy terminus of the PL.  The carboxyterminal sequences of NS1 are unique and different in H5N1 as compared to seasonal influenza and provide the scientific basis for selective and specific detection of avian influenza viruses containing ESKV, ESEV, and ESEI sequence motifs in the PL of the NS1 protein.

Intended Use: The Focus Diagnostics Influenza A H1N1 (2009) assay is intended for use on the 3M Integrated Cycler as part of the Microfluidic Molecular System for the in vitro qualitative detection and differentiation of influenza A and 2009 H1N1 influenza viral RNA in nasopharyngeal swabs (NPS), nasal swabs (NS), and nasopharyngeal aspirates (NPA) from human patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors.

Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.

Performance characteristics for influenza A were established during the 2009-2010 influenza season when 2009 H1N1 influenza was the predominant influenza A virus in circulation. When other Influenza A viruses are emerging, performance characteristics may vary.

Device Description: The Influenza A H1N1 (2009) assay is a nucleic acid amplification test that uses real-time reverse transcriptase polymerase chain reaction (RT-PCR) to detect and differentiate influenza A and 2009 H1N1 influenza from nasopharyngeal swab (NPS), nasal swab (NS) and nasopharyngeal aspirate (NPA) specimens

Patient specimens are collected and placed in sterile viral transport media containing protein stabilizer, antibiotics to inhibit bacterial and fungal growth, and buffer solution.  An extraction control (AR IC) is added to the specimen prior to nucleic acid extraction by either the MagNA Pure Total Nucleic Acid Isolation Kit (Roche) or a Qiagen Viral RNA Mini Kit.

• Reproducibility Study
• Traceability, Stability, Expected values (controls, calibrators, or methods)
• Detection limit
• Analytical Reactivity
• Assay cut-off
• Analytical Specificity

The same is applicable for CE Marking under IVDR also.

No Guidance available  for 510k submission and IVDR CE Marking