According to limited data, all RATs intended for home use in Australia are capable of detecting Omicron. It is unfortunate that not all RATs have been independently test. You might be one of them.
The WHO requires manufacturers to submit updated test data every time a new variant is available to demonstrate their tests comply with the guidelines. Although you have not been tested for COVID-19 by a rapid antigen (RAT) test, you are close to a family member who has and may be positive. You might wonder if your COVID test is accurate or if it’s working properly.
Your RAT might not deliver the results you expected. There are many factors that could explain why. One factor to consider is whether RATs are capable of detecting the Omicron version of SARS-CoV-2 (the virus that causes COVID).
The pandemic caused the virus to evolve. Researchers and health officials are now investigating whether RATs still detect the most recent version.
All Australian RATs intended for home use have been testing and found to capable of detecting Omicron, based on the limited data available. Unfortunately, not all RATs have yet been independently test. You might be one of them. According to the limited data available, all RATs intended for home use in Australia are capable of detecting Omicron. It is unfortunate that not all RATs have been independently test. One of them might be you.
What Do Mutations Have To Offer Rats?
Specific viral proteins are detect by RATs to diagnose COVID infection. There are fears that the virus may evolve and produce altered viral proteins which could affect the ability of the tests to diagnose COVID.
Authorities and researchers from various countries have raised concerns about whether RATs are capable of correctly detecting Omicron. This includes The Netherlands and Belgium.
One Australian study evaluated six RATs for Omicron lineages Omicron lines BA.4, Omicron lineages Omicron BA.5, and Omicron BA.2.75. Researchers found that the kits performed equally well in different viral loads (higher levels of the virus) although one kit’s overall sensibility fell below the minimum requirements.
However, there have been international studies that show RATs are less capable of detecting Omicron, especially when viral loads are lower.
So What’s The Case In Australia?
The Therapeutic Goods Administration (TGA) in Australia was initially able to use test data from RAT manufacturers to determine if the test kit met World Health Organization standards acceptable sensitivity (ability to detect a positive case).
They are testing to determine if they can detect wild-type viruses (the original strain), the Delta variation, and the Omicron variant. The TGA doesn’t specify which Omicron Descendents or lineages are included in the testing.
The TGA completes an analysis of individual tests or groups of tests and reports it in a table. This table is publicly accessible. It will update with new data as they become available.
What Does The Table Tell Us?
It is possible to look up the manufacturer, brand name, and batch number for the RAT that you have at your home. You should look for the ones that are labeled “self-tests” (more information on the various types of tests and their results later).
The columns that indicate whether the kit has passed independent validation are the most important in the table. Four ticks indicate that the kit has met minimum standards for detecting the original virus, Delta, and Omicron variants and passed the quality control test. If the cross is not present, it means that it has not passed this component of validation.
Are You Still Looking For A Rat Result?
Only one product can tested if it comes in two versions: a self-test or a test used in healthcare facilities, known as a POCT (see the table).
You can use the results to conduct your test. To ensure you are comparing like with like, look for a matching registration number.
The last column shows the type of data that the manufacturer provided. Some manufacturers have tested their Omicron lineages’ sensitivity BA.4 or BA.5.
What Does The Table Not Tell Us?
Your test may not have any ticks or crosses, but that doesn’t necessarily mean it cannot detect Omicron. The independent validation may not have been completed or uploaded to this table. The jury is out.
It does not indicate what Omicron lineages were tested, though in some cases the manufacturer may have provided clinical test data.
As of October, the table data was not current. We don’t know how this affects the sensitivity of the tests that were validated recently, considering the increase in sub-variant cases.
I’ve Grappled With The Table, Now What?
Your brand of rat has ticks for Omicron if it is. Check the table to verify that the brand you’re considering buying has been tested for Omicron sensitivity.
