TGA Updates Guidance on COVID-19 Rapid Antigen Test Performance and Risk Mitigation

The Therapeutic Goods Administration, TGA, has updated its guidance on performance requirements and risk mitigation for COVID-19 rapid antigen tests.

The document is intended to assist sponsors and manufacturers in preparing documentation for applications for COVID-19 rapid antigen tests and was last updated on 31 August 2026.

Purpose and Scope

The guidance provides manufacturers and sponsors with TGA expectations regarding performance requirements, including analytical and clinical sensitivity and specificity, as well as risk mitigation for COVID-19 rapid antigen tests.

The guidance applies to both point-of-care tests and self-tests, and refers only to COVID-19 caused by SARS-CoV-2. It does not cover tests for other coronaviruses or COVID-19 rapid antibody tests.

TGA also states that the analytical and clinical performance requirements assigned to rapid antigen self-tests are considered state of the art for COVID-19 rapid antigen tests and are also applicable to rapid antigen point-of-care tests.

Public Health Context

The guidance explains that COVID-19 rapid antigen self-tests can improve access to testing and allow individuals to obtain quick results, supporting early detection of infectious cases and potentially reducing community transmission.

However, TGA also highlights risks, including under-reporting of positive results, failure to report into public health systems, and the impact of these issues on contact tracing, testing rates, case numbers and epidemiological monitoring of variants of concern.

Analytical Performance Requirements

Sponsors and manufacturers must provide evidence to demonstrate the analytical performance characteristics of the test.

The technical file is expected to include analytical studies covering sample stability, analytical sensitivity, analytical specificity, precision, high-dose hook effect, stability studies and validation of internal controls.

TGA states that COVID-19 rapid antigen tests should have an analytical sensitivity of at least 10²–10³ TCID50/mL, accompanied by a Ct value stating the number of virus copies per mL.

Clinical Performance Requirements

Evidence supporting clinical performance is required for both self-tests and point-of-care tests.

Manufacturers must clearly identify whether the device is intended to detect COVID-19 in symptomatic individuals only or also in asymptomatic individuals.

For symptomatic testing, clinical performance studies should demonstrate test performance in symptomatic individuals and detect predominant variants of concern and variants of interest in global circulation.

As a minimum, COVID-19 rapid antigen tests must meet the following clinical performance requirements for each claimed specimen type:

• clinical sensitivity of at least 80% for specimens collected within seven days of symptom onset;

• clinical specificity of at least 98%.

Asymptomatic Screening

For manufacturers seeking claims related to testing asymptomatic individuals, TGA requires evidence to support those claims.

The guidance notes that rapid antigen testing in asymptomatic individuals is generally associated with markedly reduced clinical performance compared with testing symptomatic individuals. It also highlights increased likelihood of false negative and false positive results in low-prevalence community settings.

TGA recommends that studies supporting asymptomatic claims include at least 20 consecutively collected asymptomatic positive specimens and at least 100 consecutively collected negative specimens, with all specimens also tested using a comparator PCR test.

Requirements for Self-Tests

COVID-19 rapid antigen self-tests are intended for use in the home or a similar environment by a lay person.

TGA states that individuals with positive results should be directed to check any additional testing or reporting requirements with their relevant state or territory health department. A negative result does not mean a person does not have COVID-19.

Instructions for sample collection and test performance must be well-designed, easy to read, locally adapted and user-friendly. They should explain environmental conditions, incubation times, timing between sampling and reading, and correct interpretation of results in an illustrated and accessible way.

Usability Studies

Because self-tests are used by lay persons, TGA requires usability studies to establish test performance in the hands of intended users.

The study population should represent the intended user population, including different ages, education levels and people who may not use English as their preferred language. Participants with prior medical or laboratory training, or prior self-collection or self-testing experience for COVID-19, should be excluded.

Usability studies should assess user comprehension, interpretation of contrived results, diagnostic sensitivity and specificity in lay use, inter-reader variability and invalid test rate.

Risk Mitigation and IFU Requirements

TGA identifies false negative and false positive results as key risks, especially when testing occurs outside the period of highest viral shedding, when specimen quality varies, or when community prevalence is low. These risks are increased in a self-testing environment due to user variability.

Risk mitigation strategies include straightforward specimen collection, clear instructions, easy test performance, additional user support resources, product stability across Australian conditions, detection of globally circulating SARS-CoV-2 variants and helpline or online operator support.

The IFU must clearly outline test limitations and provide simple instructions on performing and interpreting the test, multilingual information, variant detection information, clinical sensitivity and specificity, timing of use, false negative warnings, repeat testing recommendations, safe disposal instructions and reporting guidance.

Associated Software and Mobile Applications

The guidance also addresses associated software and mobile applications.

If an app only records, transmits or generates a digital record, TGA states it would not be considered a medical device. However, if the app analyses or enables interpretation of the test result, it will be considered a separate analysis IVD medical device software and require separate inclusion in the ARTG.

Manufacturers must provide evidence for app performance, including usability, functional and non-functional performance, validation data, architecture and design, cybersecurity risk management, privacy management and instructions for lay users.

Comparable Overseas Regulator Approvals

TGA states that it recognises regulatory approval from Comparable Overseas Regulators, or CORs, to support applications for inclusion in the Australian Register of Therapeutic Goods.

However, the guidance also notes that devices within the scope of this document are subject to specific requirements that may differ from those of other comparable regulators. TGA may consider overseas approval evidence as demonstrating compliance with Essential Principles and may select applications for non-mandatory audit based on identified risks.

The page history notes that the 31 August 2026 update added information on selecting Class 3 self-test kits for respiratory viruses for non-mandatory audit, particularly where applications are supported by COR approvals, most notably IVDR.

Post-Market Monitoring and Advertising

Sponsors of self-tests included in the ARTG have ongoing responsibilities, including allowing inspections, providing samples upon request, making technical documentation available, ensuring advertising compliance and reporting incidents, performance issues and overseas regulatory actions to TGA.

TGA may also impose additional non-standard conditions, such as user support, instructional videos, providing IFUs for publication on the TGA website, complaint reporting, post-market surveillance reports and distribution or performance data reporting.

The guidance also highlights advertising requirements, including that advertising must be accurate, balanced, not misleading, consistent with the ARTG intended purpose and not imply that the product is “TGA approved.”

Impact on IVD Manufacturers and Sponsors

For IVD manufacturers and sponsors of COVID-19 rapid antigen tests, the updated TGA guidance reinforces the importance of robust analytical and clinical evidence, usability validation for self-tests and strong post-market monitoring.

Manufacturers and sponsors should pay particular attention to:

• analytical sensitivity and specificity evidence;

• detection of globally circulating SARS-CoV-2 variants;

• clinical performance in symptomatic users;

• evidence for any asymptomatic testing claims;

• specimen type validation and equivalence;

• lay-user usability studies;

• IFU clarity and multilingual accessibility;

• false negative and false positive risk mitigation;

• associated software and app classification;

• COR approval evidence and potential audits;

• ARTG post-market obligations;

• advertising compliance.

For sponsors preparing Australian submissions, the key message is that COVID-19 rapid antigen tests must demonstrate appropriate performance, usability and risk controls across both premarket documentation and post-market lifecycle monitoring.