The TGA has completed a post-market review of NATs designed for detection of influenza A virus. Influenza A NATs are used in clinical or laboratory settings due to the need for specialised equipment and expertise. This review was undertaken to support use of NATs in these specialised settings, and to determine the ability of NATs to detect specific strains of avian influenza A H5N1, particularly:
- clade 2.3.4.4b (globally circulating strain), and
- clade 2.3.2.1a (the first imported human case of avian influenza A in Australia).
Avian influenza
Avian influenza (bird flu) is a viral disease caused by various strains of influenza A viruses, which mainly infects birds but can also infect other animals and, on rare occasions, humans. The severity of disease in infected birds and animals can vary from no signs of disease or mild disease to severe disease resulting in higher number of deaths.
A strain of H5 avian influenza (H5N1 clade 2.3.4.4b), has spread quickly around the world, causing widescale outbreaks in poultry, wild birds and mammals. As of 25 May 2025, H5N1 clade 2.3.4.4b has not been detected in any birds or other animals in Australia.
The likelihood of humans being infected with H5N1 clade 2.3.4.4b is rare and typically occurs only upon close contact with infected birds and animals, or a contaminated environment. Human infections caused by H5N1 2.3.4.4b have been reported overseas and the severity of infection has varied from no symptoms or mild illness to severe disease resulting in death. However, there have been no reported cases of human-to-human transmission.
Influenza A NATs
Influenza A NATs are used in clinical or laboratory settings due to the need for specialised equipment and expertise.
These NATs are diagnostic tests used to detect the presence of influenza A virus by identifying its genetic material, ribonucleic acid (RNA), in respiratory samples. These tests are highly sensitive and specific, allowing accurate identification of viruses even in small quantities. Influenza A NATs are useful for accurate diagnosis during influenza seasons, outbreaks or pandemics.
Influenza A NATs identify influenza A virus by binding to a specific location (target site) of the RNA. Influenza A RNA often tends to change and mutate rapidly. If the virus mutates in the area the test looks for, it might not be detected, which could lead to false negative results. Therefore, it is important to periodically assess how the emerging strains of influenza A viruses will affect the performance of these tests.
Influenza A NATs can detect many types of flu A viruses, including H5N1, H7N3, H7N8, H7N9, and H9N2. But they usually can’t tell which exact type it is. So, while the test can confirm someone has the flu, more testing might be needed to find out the specific subtype.
Post-market review: background
The TGA continues to monitor the situation in relation to outbreaks of avian influenza A H5N1 strain in poultry, wild birds and mammals overseas, as well as other avian influenza A strains in a number of poultry farms within Australia.
As of 25 May 2025, the globally circulating H5N1 strain, clade 2.3.4.4b, has not been reported in Australia. Several other avian influenza A subtypes such as H7N3, H7N8, H7N9 and H9N2, have been detected in poultry farms in number of Australian states.
We initiated a post-market review of influenza A NATs as a proactive measure to determine their ability to detect the emerging strains of avian influenza A, particularly H5N1 clades 2.3.2.1a and 2.3.4.4b.
We required all sponsors of influenza A NATs included in the Australian Register of Therapeutic Goods (ARTG) to provide information to us about their devices, including:
- model list
- supply data
- instructions for use
- test kit design
- testing to support the performance of the devices
- manufacturers plan for monitoring new strains, and any associated data or reports.
Post-market review: outcomes and actions
We have reviewed the information provided by the sponsors and manufacturers of all influenza A NATs included in the ARTG.
As part of this review, we conducted a desktop analysis to determine diagnostic performance of influenza A NATs against H5N1 strains, particularly clades 2.3.2.1a and 2.3.4.4b.
The details of the outcomes, and actions undertaken by sponsors and manufacturers, are summarised in Table 1 below.
Devices included in the review
The influenza A NATs that were included in the post-market review and any associated outcomes are listed below.
| ARTG | Sponsor | Manufacturer | Product name | Outcome |
|---|---|---|---|---|
| 302869 | Abacus dx Pty Ltd | CerTest Biotec SL | VIASURE Flu A+B Real Time PCR Detection Kit (IAB) | No impact identified on test kit’s performance. |
| VIASURE Influenza A Real Time PCR Detection Kit (YIA) | No impact identified on test kit’s performance. | |||
| VIASURE Influenza Flu Typing II Real Time PCR Detection Kit (HXN) | The TGA identified potential impact on the test kit’s performance. Sponsor has updated the IFU to include additional warnings that the detection of H5N1 clades 2.3.2.1a and 2.3.4.4b may be compromised. No current supply in Australia.
| |||
| 386639 | Abbott Australasia Pty Ltd Molecular Division | Abbott Molecular Inc | Abbott Resp-4-Plex assay (Alinity m Resp-4-Plex) | No impact identified on test kit’s performance. |
| 216106 | Abbott Rapid Diagnostics Pty Ltd T/A Alere | Abbott Diagnostics Scarborough Inc also d/b/a Alere Scarborough Inc | ID NOW Influenza A & B 2 | No impact identified on test kit’s performance. |
| 308340 | Becton Dickinson Pty Ltd | CerTest Biotec SL | VIASURE FluA, FluB & RSV Real Time PCR Detection Kit 444200 | No impact identified on test kit’s performance. |
| VIASURE SARS-CoV-2, Flu (A+B) & RSV Real Time PCR Detection Kit 444217 [Flu A, Flu B & RSV reaction tube] | No impact identified on test kit’s performance. | |||
| 311930 | Becton Dickinson Pty Ltd | Becton Dickinson and Company | BD Respiratory Viral Panel (RVP) for BD MAX™ System (SARS-CoV-2, Flu A/B, RSV) | No impact identified on test kit’s performance. |
| 224167 | Biomerieux Australia Pty Ltd | BioFire Diagnostics LLC | FilmArray Pneumonia Panel plus | No impact identified on test kit’s performance. |
| BioFire Respiratory Panel 2.1 plus (RP2.1plus) assays | No impact identified on test kit’s performance. | |||
| 231513 | Cepheid Holdings Pty Ltd | Cepheid | Xpert® Xpress SARS-CoV-2/Flu/RSV (Models XP3COV2/FLU/RSV-10 and XPRSFLU/RSV-CE-10) | No impact identified on test kit’s performance. |
| 216256 | DiaSorin Australia Pty Ltd | DiaSorin Molecular LLC | Simplexa Flu A/B & RSV (MOL2600) | No impact identified on test kit’s performance. |
| Simplexa Flu A/B & RSV Direct (MOL2650) | No impact identified on test kit’s performance. | |||
| Simplexa Flu A/B & RSV Direct Gen II (MOL2655) | No impact identified on test kit’s performance. | |||
| 296043 | Hologic (Australia & New Zealand) Pty Ltd | Hologic Inc | Aptima SARS-CoV-2/Flu Assay | The TGA identified potential impact on the test kit’s performance. However, the device had no supply in Australia in 2023/2024 and has now been obsoleted.
|
| Panther Fusion Flu A/B/RSV assay | No impact identified on test kit’s performance. | |||
| Panther Fusion SARS-Cov-2 Flu A/B/RSV assay | No impact identified on test kit’s performance. | |||
| 299690 | Roche Diagnostics Australia Pty Limited | Roche Molecular Systems Inc | cobas® SARS-CoV-2 & Influenza A/B | No impact identified on test kit’s performance. |
| 339235 | Roche Diagnostics Australia Pty Limited | TIB MOLBIOL Syntheselabor GmbH | LightMix® Modular Influenza A | No impact identified on test kit’s performance. |
| 422123 | Sonictec Pty Ltd | Jiangsu Macro & Micro-Test Med-Tech Co Ltd | Macro & Micro-Test SARS-CoV-2/Influenza A/Influenza B Multiplex Assay | The TGA identified potential impact on the test kit’s performance. However, the manufacturer performed additional testing to demonstrate no impact on performance. No current supply in Australia.
|
| 399811 | Stonestar Wholesale Pty Ltd | VivaChek Biotech (Hangzhou) Co Ltd | VivaDiag™ SARS CoV 2/Flu A/Flu B RT PCR Kit | No impact identified on test kit’s performance. |
| 411056 | Thermo Fisher Scientific Australia Pty Ltd | Life Technologies Corporation | TaqPath™ COVID-19 Flu A/B RSV Combo Kit | No impact identified on test kit’s performance. |
| 227047 | Vela Diagnostics Australia Pty Ltd | Vela Operations Singapore Pte Ltd | Sentosa SA Influenza A/B & RSV RT-PCR Test | The manufacturer identified decreased performance against the H5N1 and H9N2 strains. Sponsor has updated the IFU to include additional warnings about decreased sensitivity against H5N1 and H9N2 strains. No current supply in Australia. |
Information for consumers and healthcare professionals
As of 25 May 2025, the TGA is aware of only one imported human case of H5N1 (clade 2.3.2.1a) in Australia, which was confirmed on 18 May 2024. However, consumers with potential exposure to avian influenza A virus should consult their health practitioner for appropriate testing and diagnosis in a certified laboratory or clinical setting.
Health practitioners should refer to the national guidelines published by the Communicable Diseases Network Australia (CDNA), for cases of suspected or confirmed avian influenza A.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to our monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
We cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.