Australia Approves First Combined Flu and COVID-19 Tests

Australia Approves First Combined Flu and COVID-19 Tests

Australia's Therapeutic Goods Administration (TGA) has approved the country's first self-tests that can detect both Influenza A/B and COVID viral infections in individuals 

The recent TGA review has cleared the Biolink Flu A/B + COVID Rapid Antigen Test, alongside the TouchBio and Fanttest combo tests, for self-testing at home use. The tests were cleared after an extensive review of clinical and analytical data demonstrating their minimum performance criteria.


New cutting-edge rapid test detects both COVID-19 and the flu

Combination self-tests function similarly to other COVID-19 rapid antigen tests (RATs), but have an additional test line on the cassette or pen device that indicates the presence of Influenza A and B. This helps to distinguish between each viral infection for more accurate symptom management.

The tests will be made available in pharmacies, supermarkets, and online retailers, packaged with TGA-approved instructions for use, telephone support details, and links to online instructional videos.

The TGA has stated that sponsors of the tests must provide ongoing quality and performance information to monitor their efficacy, including any false positives or false negatives experienced by users, and any evidence that the tests function with any emerging COVID-19 variants—keeping users safe and up-to-date with product performance.
The tests will be undergoing additional independent laboratory verification testing by the Doherty Institute for Infection and Immunity, and the National Reference Serology Laboratory. 

How do Influenza A/B combo antigen tests work?

Combination Flu RATs are used in the detection of Influenza A and B. Combination COVID + Flu RATs detect infections caused by the Influenza A and B viruses, and the COVID-19 virus. The latest generation of RATs can detect both the flu and COVID-19 with just one swab.

The dual test is housed either in a cassette, or pen for Biolink tests, that contains a lateral flow strip for adding sample secretions and a window labelled C (control), A (influenza A), B (influenza B), and T (test for COVID-19).

If a line becomes visible at A and C, the test is positive for Influenza A. If a line becomes visible at B and C, the test is positive for Influenza B. If there are visible lines at A, B, and C, the test is positive for both Influenza A and B. In the COVID-19 window, a line becomes visible at C and T if the test is positive for the virus. The test is invalid if there is no line at C.

Rapid antigen tests are generally highly effective at detecting COVID-19 or the flu; testing is an essential public health precaution, and key to receiving the right medication or treatment.

However, COVID-only RATs are not capable of detecting flu infections, as they are designed to detect only the coronavirus. It's important to check that the test you use is designed specifically for the detection of Influenza A/B, or it's a combo COVID + Flu test. Professional rapid antigen tests are also available for medical professionals to use in detecting flu.

Regardless of any self-test results, it's essential to seek professional medical attention if you suspect you may have an infection caused by either COVID-19 or the flu.


How does the COVID + Flu RAT, and Flu RAT differ from other tests?

The combination self-tests function similarly to other COVID-19 RATs but have an additional line on the test pen that indicates the presence of Influenza A and B, distinguishing between COVID and flu infections for the management of symptoms.

Detecting the right infection is particularly important as both infections can have similar symptoms, and will require different treatments. Proper and prompt medical attention is necessary to receive a proper diagnosis and treatment. It's also crucial to follow recommended preventive measures, such as wearing masks, social distancing, and practising good hygiene, to reduce the risk of both COVID-19 and flu infections.

With the right precautions and prompt detection, we can work towards reducing the spread of these illnesses and protecting public health.

Other than tests that detect Influenza and COVID-19, what else can I do to prevent or manage the flu this year? 

Getting vaccinated against the flu and COVID-19 can be an effective way to prevent these illnesses and their complications. It is important to consult with a healthcare provider about vaccination options and follow their recommendations. In case of any symptoms related to flu or COVID-19, individuals should immediately seek medical attention to protect themselves and prevent further spread of the disease.

Image of a test in a lab 


 Early diagnosis and treatment can help reduce the severity of the illness and prevent any complications. It is also good practice to stay informed about the latest updates and guidelines regarding COVID-19 and the flu from reliable sources. 

This will help you make informed decisions about your health and prevent the spread of these diseases in your community. Overall, taking good care of our health, taking proactive steps, and following recommended preventive measures is the best way to overcome the challenges presented by the flu and COVID-19.


Benefits of the new Influenza A/B + COVID combo tests will be seen in workplaces, nursing homes, and point-of-care medical settings nationwide

The new Influenza A/B + COVID combo tests offer significant benefits for workplaces, nursing homes, and point of care medical settings.

For workplaces, with regular testing, these tests can do a lot to reduce the spread of infection, and keep employees safe and healthy. Employers can use the tests to quickly identify and isolate workers who have contracted the flu or COVID-19, helping to prevent the spread of disease and minimising disruptions to business operations.

Nursing homes also benefit from these tests as they can help track and eliminate the spread of the virus among vulnerable residents and staff. The tests can quickly identify new infections, enabling nursing homes to take measures to contain them and limit the number of people affected.

In medical and point-of-care settings, these tests aid healthcare professionals in identifying patients with flu or COVID-19 quickly and accurately, so that they may provide them with the right care they need to recover.

Ultimately, the ability to provide accurate results quickly, makes Influenza A/B + COVID combo tests an invaluable tool in combating the spread of flu and COVID-19 in a variety of settings.


Which Flu RAT should be used and when should it be administered?

The TGA provides a list of authorised tests on its website. Simply search for the term "combination" to find all currently available combo tests that utilise nasal swabs for sample collection. Most of the listed tests boast a "very high sensitivity" rate, meaning they obtain the same positive case detection as the gold standard PCR test 95% of the time.

The remaining tests perform with "high sensitivity" (90% agreement with PCR). It is advisable to perform the test within four days of developing symptoms to detect both influenza and COVID accurately: a more reliable test result can be found if symptoms exist. 


When should you use a COVID + Flu RAT? 

It is advisable to test to see if you have COVID or the flu if you are experiencing common viral respiratory symptoms. Knowing whether you have flu or COVID enables you to take necessary measures to protect others, such as working from home, avoiding contact with vulnerable people, and wearing a mask when you're around others.

If you test positive for COVID, it may also affect the timing of your booster vaccine as recommended by the Australian Technical Advisory Group on Immunisation, which suggests waiting for six months after a COVID infection to increase protective immunity. Thus, it is helpful to know if you have been infected. Secondly, antiviral treatment varies depending on whether you have flu or COVID. Find out more about influenza here.

Moreover, understanding the difference between flu and COVID specific symptoms can help you determine which illness you have. While both may present with fever, cough, and fatigue, COVID may also cause loss of taste or smell, difficulty breathing, and severe body aches. On the other hand, flu often comes with a runny nose, sore throat, and headaches.

It is important to seek medical advice and get tested if you suspect you may have either illness and to follow public health guidelines to prevent the spread of disease. 

In summary, rapid antigen tests have been incredible tools that aided us in preventing the spread of COVID-19 during the pandemic. Now, with the approval of COVID and Flu RATs in Australia, their use as a detection tool can extend to preventing the spread of flu too.

By quickly identifying people carrying the flu virus, healthcare professionals can take swift action to prevent it from spreading further. This is a massive help during yearly flu seasons, when the virus can cause significant illness and even death, especially in vulnerable populations.

Though RAT tests were initially popularised for use against COVID-19, their benefits extend far beyond the pandemic and can help to keep us all healthier in the long run. 

If you'd like to find out more about Biolink's range of tests, including our Flu RATs and COVID + Flu RATs, contact us here.

Ana Martins

Ana is Biolink's Senior Medical Product Engineer
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