Understanding performance requirements for in-vitro diagnostic (IVD) self-tests for chlamydia, gonorrhoea and syphilis

As per the Therapeutic Goods (Medical Devices – Excluded Purposes) Specification 2020, sponsors and manufacturers may apply for ARTG inclusion of specified IVD self-tests, including tests for chlamydia, gonorrhoea and syphilis. These tests can only be supplied after evaluation by the TGA or a comparable overseas regulator or assessment body to confirm performance, safety and risk mitigation requirements are met. Where reliance is placed on overseas assessments, the TGA may conduct additional review based on relevant risk factors outlined in Understanding selection criteria for medical device application audits (Therapeutic Goods Administration).

Sexually transmitted infections (STIs), including chlamydia, gonorrhoea and syphilis, have remained a significant public health issue in Australia. The prevalence of these STIs have risen within the general Australian population, with significant increases in the notification rate of all three STIs within the last decade.

In combination with emerging issues that require public health monitoring, STI’s are a persistent and growing issue within the Australian population. These STI’s are all treatable with antibiotics, however early detection is key to reducing the transmission and associated complications.

The Department of Health, Disability and Ageing in 2024 published the Fifth National STI Strategy 2024–2030. Outlined in these strategies are key areas of focus including increasing the STI testing coverage in certain populations and to reduce the prevalence of chlamydia, gonorrhoea and syphilis. 

This strategy in combination with the Fifth National Aboriginal and Torres Strait Islander Blood Borne Viruses and Sexually Transmissible Infections Strategy 2018-2022 and the Action Plan: Enhanced response to addressing sexually transmissible infections (and blood borne viruses) in indigenous populations aims to increase accessibility to testing and treatment for STIs.

Legal supply of chlamydia, gonorrhoea and syphilis self-tests may improve access for testing, including in regional and remote areas, and allow self-test kits to be safely and legally distributed in Australia.

Reduced delays in testing may support earlier access to intervention, increase access to support services for individuals who test positive, and increase access to appropriate treatment that could reduce prevalence and acute health consequences associated with these STIs.

All self-tests for serious diseases should demonstrate a high standard of clinical performance relative to the intended purpose and classification of the test (Essential Principles 14 and 15 of the Therapeutic Good (Medical Devices) Regulations 2002 (the Medical Device Regulations). This also includes specific requirements for self-tests in accordance with Essential Principle 15:

• An IVD medical device for self-testing must be designed and manufactured so that it performs appropriately for its intended purpose, taking into account the skills and the means available to users and the influence resulting from variation that can reasonably be anticipated in the user’s technique and environment

• The information and instructions provided by the manufacturer of an IVD medical device for self-testing must be easy for the user to understand and apply; and

• An IVD medical device for self-testing must be designed and manufactured in a way that reduces, to the extent practicable, the risk of error in the use of the device, the handling of the sample and the interpretation of results.

Different clinical performance requirements and risk mitigation strategies, including conditions of approval, are applicable depending on the nature of the test and take into consideration:

• the intended purpose of the test (e.g., presumptive screening test)

• the target of the test (e.g., antigen or antibody)

• the environmental conditions under which the test would be conducted by a lay person (i.e., in the hands of an untrained/inexperienced user)

• the specimen type (e.g., fingerstick whole blood, first pass urine or swabbing); and

• any limitations of the intended use, including the need for confirmatory laboratory testing and follow‑up by a medical practitioner.

For an IVD medical device for self-testing, a lay person is defined as an individual who does not have formal training in a medical field or discipline to which the self-testing relates.

For the full definition, refer to the Therapeutic Goods (Medical Devices) Regulations 2002.

The purpose of this approach is to balance the need for high quality tests with clinical characteristics that are fit for purpose.

Overall acceptability of any test for the purposes of inclusion in the ARTG depends on compliance of the test device with the Essential Principles and in particular, a demonstration that the test does not compromise health and safety, is suitable for the intended purpose and the benefits of the test outweigh any residual risks associated with its use (Essential Principles 1, 3 and 6).

Advertisements for IVDs, including self-tests, are subject to the requirements of the Act. For advertising to consumers, this includes the requirement to comply with the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Advertising Code).

The Advertising Code requires advertising to consumers to be accurate and not misleading (including misleading through the omission of important information, like the limitations of an IVD).

Consumer advertising for IVDs for detecting or diagnosing a serious disease, condition, ailment or defect is likely to contain a restricted (e.g., hepatitis B virus) or prohibited (e.g., chlamydia, gonorrhoea and syphilis) representation. Under the Act, the TGA must authorise these types of representations prior to their use in consumer advertising. 
More information is available at restricted and prohibited representations.

Chlamydia, gonorrhoea and syphilis self-tests are rapid presumptive screening tests intended to be used in the home or similar environment by a lay person. Follow-up with a medical practitioner is required for confirmation of positive results using a laboratory test and for reporting of a notifiable disease. 

Clinical characteristics and clinical performance requirements for chlamydia and gonorrhoea self-tests

Study design

Clinical performance studies for chlamydia and gonorrhoea self‑tests should generally be prospective in study design. This approach enables assessment of test performance under conditions representative of routine use and minimises selection bias.

Clinical study participant recruitment criteria should be clearly defined and consistent with the intended use of the device:

• The enrolled study population should be representative of the intended users, including relevant characteristics such as age, sex, symptoms, and other factors relevant to the claimed use.

• Inclusion and exclusion criteria should be clinically appropriate and should not result in selective enrolment that may bias estimates of clinical performance.

• Studies should include participants from both high prevalence and low prevalence settings, which may include diverse geographic or clinical settings, to ensure that performance estimates are representative of the intended use population in the Australian context.

• The study population should reflect the full spectrum of disease and analyte reactivity relevant to the claimed use. Appropriate numbers of borderline or low-reactive specimens should be included to support reliable estimates of device performance.

• Recruitment settings and specimen collection procedures should reflect routine use conditions, as described in the instructions for use.

Retrospective or archived‑specimen studies may be provided as supplementary evidence, where specimen characteristics, clinical status, and reference method results are well characterised and appropriately justified. These studies may be appropriate where prospective recruitment is impractical, or where additional evidence is needed for specific specimen types, population groups, low-prevalence settings, or clinically relevant result ranges. However, they should not generally replace prospective clinical performance studies. Evidence generated using retrospective or archived specimens should be interpreted in the context of the overall clinical evidence package, including the extent to which it is supported by prospective clinical performance data.

Minimum clinical performance requirements

Chlamydia and gonorrhoea self-tests must meet minimum clinical performance for the claimed clinical sensitivity and specificity for a self-test across the relevant specimen types such as vaginal, anal or urine samples:

• an overall clinical sensitivity of at least 95%; and

• an overall clinical specificity of at least 99%.

This reflects the expected performance of the test with clinical specimens in comparison to a currently accepted reference standard (e.g., Polymerase Chain Reaction (PCR)). 

The clinical performance evaluation of a chlamydia and gonorrhoea self-test should be supported by statistically justified numbers of positive and negative clinical specimens. Sample sizes should be sufficient to support the study objectives and provide adequate statistical confidence in the reported performance estimates.

Clinical performance results for sensitivity and specificity should be reported with associated two-sided 95% confidence intervals. Positive samples are expected to be characterised and discordant results investigated using testing algorithms in accordance with a well-established laboratory case definition for chlamydia or gonorrhoea. 

Clinical performance characteristics should be determined across all claimed population groups described in the instructions for use (IFU), including asymptomatic individuals where applicable.

Manufacturers claiming that their kit detects chlamydia or gonorrhoea in different sample types must conduct parallel testing to demonstrate specimen equivalence. 

Contrived samples are not acceptable for determining clinical sensitivity and specificity. 

Clinical performance studies should include information on when clinical samples were taken (i.e., days post symptom onset), the type of sample tested, and clearly identify the optimal period for testing consistent with the intended use of the device.

Clinical characteristics and clinical performance requirements for syphilis self-tests

The TGA will have regard to the European Union (EU) Common Specifications (CS) established under Regulation (EU) 2017/746 (IVDR), including those set out in Commission Implementing Regulation (EU) 2022/1107, when assessing the technical performance specifications and clinical evidence for syphilis self‑tests. Additional considerations relevant to the Australian regulatory context are outlined below.

Syphilis self-tests are generally antibody-based tests (i.e., treponemal tests) intended to detect antibodies to Treponema pallidum. These tests do not differentiate between current (active) infection and a previously treated infection, as antibodies typically persist following treatment. 

A reactive (positive) self-test result does not confirm active infection. Confirmatory testing using appropriate laboratory-based methods is required to establish a diagnosis, inform clinical management, and support notification requirements for a notifiable disease.

study design

Clinical performance studies should generally be prospective in design. 

Clinical study participant recruitment criteria should be clearly defined and consistent with the intended use of the device:

• The enrolled study population should be representative of the intended user population, including relevant characteristics such as age, sex, symptoms, disease stage, and other factors relevant to the claimed use.

• Inclusion and exclusion criteria should be clinically appropriate and avoid selective enrolment that may bias performance estimates.

• Studies should include participants from both high prevalence and low prevalence settings, which may include diverse geographic or clinical settings, to ensure that performance estimates are representative of the intended use population in the Australian context.

• The study population should reflect the full spectrum of syphilis infection, including disease stages and analyte reactivity levels. Appropriate numbers of borderline or low-reactive specimens should be included to support reliable estimates of device performance.

• Recruitment settings and specimen collection procedures should reflect routine use conditions, as described in the instructions for use.

Well characterised archived specimens may be included as supplementary evidence, if specimen characteristics and reference method results are clearly defined and appropriately justified, particularly when prospective recruitment is impractical or additional evidence is needed for specific specimen types, populations or clinical scenarios. However, they should not generally replace prospective clinical performance studies, and their findings should be considered alongside the overall clinical evidence package, including any supporting prospective data.

Minimum clinical performance requirements

Syphilis self‑tests are expected to demonstrate a high level of clinical sensitivity and specificity.

These tests may involve alternative specimen types to what is utilised in clinical settings, including finger stick whole blood, and may not necessarily perform to the same standard as laboratory tests that are intended for professional use. 

Syphilis self-tests must meet minimum clinical performance for the claimed clinical sensitivity and specificity for a self-test across the relevant specimen types including whole blood (finger stick):

• a clinical sensitivity of at least 95%; and

• a clinical specificity of at least 98%.

This reflects the expected performance of the test with clinical specimens in comparison to a currently accepted reference standard (e.g. third or fourth generation enzyme immunoassay (EIA)). It is expected that the self-test shall have an overall performance that is equivalent to that of the established device.

Clinical performance evaluation of a syphilis self-test is expected to be supported by statistically appropriate numbers of positive and negative specimens (see the References section for more details). Clinical performance results (sensitivity and specificity) should be reported with the associated two‑sided 95% confidence intervals. Positive samples are expected to be appropriately characterised and discordant results investigated using testing algorithms in accordance with a well-established laboratory case definition for syphilis. 

Contrived samples are not acceptable for determining clinical sensitivity and specificity.

Clinical performance studies should include information on when clinical samples were taken, the type of sample tested, and clearly identify the optimal period for testing (i.e., outside or within the window period of seroconversion) consistent with the intended use of the device.

Performance should be assessed across relevant stages of infection (e.g. early, latent, and late disease). The effect of seroconversion on test performance should be characterised.

As chlamydia, gonorrhoea, and syphilis self‑tests are intended to be performed by lay users, manufacturers must provide usability studies demonstrating that the device performs as intended in the hands of these users. 

Manufacturers are not required to provide Australian‑specific usability studies; however, study populations should be representative of the intended user population in the Australian context. This includes consideration of population demographics (e.g., age, sex, education, and occupation), health literacy, and aspects of the standards of care and clinical pathways that may influence device use or performance. 

Study populations should also include individuals for whom English is not the preferred language. Participants with prior medical or laboratory training should be excluded.

Usability studies are expected to address each of the aspects below. 

User comprehension

User comprehension studies should consider the ability of the user to interpret the IFU and labelling. Studies should evaluate whether the information provided is clear, easy to follow, and supports users to correctly perform the test and interpret the results. This may include the use of questionnaires to evaluate user comprehension of the test procedure, limitations, diagrams or illustrations, result interpretation, and information on appropriate follow‑up actions and access to support services.

Participants should be observed, without guidance, during specimen collection and test performance. Observation may be conducted in person or via remote visual monitoring (e.g. video conferencing), and any difficulties or errors should be documented.

Inter-reader variability

Inter‑reader variability studies should assess the ability of lay users to correctly interpret pre‑determined or contrived test results: A comprehensive inter-reader variability study should comprise:

• Contrived tests results interpreted by a minimum of 100 lay users.

• The contrived test results should reflect a range of results including non-reactive, reactive, weak reactive and invalid, with a higher proportion of the samples in the weak-positive range close to the cut-off or limit of detection of the test.

• Determination of concordance against reading and interpretation of the same test by professional or trained users for the test.

A significant inter-reader variability (e.g., ≥ 5%) for clearly positive or negative results implies that the device is not easy to use, the IFU is not clear enough, or the test results may be difficult to interpret leading to an increased rate of false negative or positive results.

Invalid test rate

The incidence of operational errors and test system failures should be determined. This includes failures in specimen collection or completion of the sequential steps required to perform the test, resulting in an invalid or unreadable result, as well as instances where the user is unable to interpret the result correctly, leading to an invalid result. Ideally the invalid test rate should be ≤ 5% of the total tested (this includes defective tests or components).

User sensitivity/specificity studies

Studies should confirm the clinical sensitivity and specificity of the test when used by lay users in the intended self-testing environment, using clinical specimens and statistically appropriate sample sizes to support reliable estimates of performance. Study populations should reflect the full spectrum of disease expected in the intended use population to ensure that clinical performance is evaluated under conditions representative of the intended use setting.

User sensitivity and specificity should be estimated against the true infection status of the individual (chlamydia, gonorrhoea, or syphilis), as determined by laboratory testing using a recognised reference standard (e.g. EIA or PCR).

The user sensitivity should be ≥95% for chlamydia, gonorrhoea and syphilis self-tests. 

A user sensitivity of <95% may be considered acceptable where evidence of significant public health benefits can be demonstrated and where thorough risk mitigation strategies have been put in place to minimise the risk of false negative and false positive results. The suitability of these studies will be assessed on a case-by-case basis and will depend on how well the manufacturer has mitigated any risks and demonstrated that the overall benefits of the product outweigh any residual risks associated with its use. 

Chlamydia, gonorrhoea, and syphilis self‑tests are presumptive screening tests used outside the clinical setting and are subject to risks inherent to self‑testing. Manufacturers should identify and mitigate these risks through appropriate device design, clinical and usability evidence, labelling, and risk management processes.

General risks applicable to all STI self‑tests include:

• User‑related errors (including incorrect specimen collection, failure to follow instructions, or incorrect interpretation of results) which may affect test performance.

• Misinterpretation of results, particularly for weak or borderline positive, or invalid results.

• Failure to seek appropriate follow‑up, particularly in a self‑testing environment where follow‑up may not easily be encouraged or implemented. This may increase the risk of delayed diagnosis, untreated infection, and onward transmission.

Additional risks associated with chlamydia, gonorrhoea, and syphilis self-tests are outlined below.

Risks specific to chlamydia and gonorrhoea self‑tests

It is expected that most self‑tests for chlamydia and gonorrhoea will be antigen‑based. Test performance may be affected by specimen quality, and false‑negative results are more likely when testing is performed early in infection, or in asymptomatic individuals, where organism load may be low or variable.

Inadequate or incorrect specimen collection (such as inappropriate sampling technique, suboptimal anatomical site selection, contamination of the specimen, or failure to follow collection timing or handling instructions) may adversely affect test performance and contribute to false‑negative or invalid results. 

Rapid antigen self‑tests for chlamydia and gonorrhoea are not intended to replace clinical assessment or laboratory testing. Confirmatory testing and appropriate medical follow‑up are required to inform treatment, particularly for gonorrhoea where antimicrobial resistance is a recognised public health concern.

Risks specific to syphilis self‑tests

Syphilis self-tests are typically antibody-based (treponemal) assays and are subject to the limitations associated with antibody testing.

False‑negative results are more likely to occur where antibody tests have lower clinical sensitivity (less than 100%), where antibody levels following past infection have waned, or where testing is performed during the ‘window’ (e.g. seroconversion) period for the device. Testing performed early in the active phase of infection, prior to seroconversion, may therefore result in false‑negative results. In some cases, syphilis serology may be negative despite the presence of symptoms.

Antibody tests for syphilis may be cross‑reactive with a number of pathogens and may also be affected by antibodies produced in autoimmune conditions, potentially resulting in false‑positive results (see the References section for more details). 

In addition, antibody tests for syphilis are unable to distinguish between active infection and previously treated infection, reinfection, infectious status, or disease progression. As a result, test results cannot reliably inform current disease status, treatment decisions, or public health risk without confirmatory laboratory testing and clinical assessment.

Benefit–risk considerations

Despite the limitations described above, the benefits gained from utilising chlamydia, gonorrhoea and syphilis self-tests may outweigh the risks (i.e. a false positive or false negative result), especially for kits with high levels of clinical sensitivity and specificity where appropriate risk‑mitigation measures are applied.

The proposed mitigating strategies recognise that self-tests differ from laboratory-based tests and point-of-care tests in that the user is responsible for all aspects of the testing process, from sample collection to result interpretation.

For chlamydia, gonorrhoea and syphilis self‑tests, consideration should be given to risks arising from lay‑user operation, use in non‑clinical test environments, and the potential public health consequences of false‑positive or false‑negative results.

Mitigation strategies for chlamydia, gonorrhoea and syphilis self‑tests include the following:

• Specimen collection

  • The specimen collection process must be straightforward, the instructions for specimen collection must be clear and easy to understand, and the specimen able to be collected safely in the home testing environment.

• Ease of use and test procedure

  • The test must be easy to perform with minimal operator intervention or procedural steps. Extensive usability studies would be expected (e.g. user comprehension, inter-reader variability, user sensitivity/specificity studies).

• Product stability

  • Product stability should be demonstrated across relevant operational and environmental conditions, including temperature, humidity, and factors associated with storage, transport, and in‑use conditions.

• Result interpretation and limitations

  • The instructions for use should clearly describe the interpretation of positive, negative, and invalid results, including weak positive results (e.g. faint lines). Any limitations of the test should also be clearly communicated to support appropriate user understanding and the safe use of the device.

• Follow‑up and clinical referral
  • As chlamydia, gonorrhoea and syphilis self‑tests are screening tests for notifiable infections, the instructions for use must clearly state that users with a positive result are required to seek follow‑up with a medical practitioner for confirmatory laboratory testing and appropriate clinical management.

Requirements for the instructions for use (IFU)

In addition, the manufacturer or sponsor of a chlamydia, gonorrhoea or syphilis self-test is also required to clearly outline the limitations of the test and provide clear advice, in the IFU or other information provided with the test, including the following:

• clearly states what the kit is testing for (i.e. antigen or antibody testing)

• clearly define the intended user population, including relevant subgroups and the applicable age range, supported by clinical and usability evidence. Any limitations, exclusions, or circumstances where the test may not be appropriate should also be clearly identified. 

• clear and simple instructions on how to perform and interpret the test (this may involve images or visual representation of the instructions, flow diagrams or QR codes linking to online demonstrations)

• available either in print or online in multiple languages (e.g. including local languages)

• the clinical sensitivity and specificity of the test (i.e. in a self-testing environment) must be clearly identified (including information on the clinical sensitivity and specificity of the test at various time points post symptom onset)

• the user clinical sensitivity and specificity of the test (i.e. in a self-testing environment) must be clearly identified

• clear information on when the test should be used, including whether it is intended for symptomatic and/or asymptomatic individuals and any relevant timing considerations (e.g. following potential exposure or symptom onset).

• clear warnings on the risk of false negative results and if testing is performed in the ‘window period’ for syphilis (and a clear explanation of what the window period is)

• a clear warning that a positive treponemal specific syphilis self-test result in an individual who has previously tested positive for syphilis cannot differentiate between successfully treated past infection and re-infection.

• Information on interfering, cross-reacting substances or agents that may affect test results

• clear indication that chlamydia, gonorrhoea and syphilis self-testing is for presumptive screening only and the need to consult a medical practitioner for confirmatory testing of positive results by a laboratory test and for advice regarding treatment if required

• warning that negative results obtained for syphilis within three months of a high-risk event should be repeated at three months to confirm the initial negative result

• warning about testing in particular situations (e.g. testing for syphilis in pregnant women and the need to seek medical advice particularly if they suspect they have syphilis or have been exposed to syphilis)

• negative results may not mean that a person is not infectious and if symptoms persist to seek medical assistance

• a negative or positive result obtained when using a self-test to detect one sexually transmitted infection does not preclude infection from other sexually transmitted infections or the presence of other conditions

• information on other limitations of the test such as a positive result cannot necessarily determine whether a person is infectious

• a statement to the user that the test can only be used once

• information on how to safely dispose of the kit and its contents

• how to contact locally available support and counselling services including phone lines and websites

• how to contact the TGA to report performance or usability issues in the self-test environment (report an issue via the Users Medical Device Incident Report, email iris@health.gov.au or call 1800 809 361); and

• IFU contains information to promote safe sex particularly during pregnancy and the need for individuals engaging in high-risk behaviours to undergo regular testing for other sexually transmitted infections and blood borne viruses. 

It is also recommended that the IFU contain information to promote good infection control procedures of individuals to reduce the spread of sexually transmitted infections to the general population.

Other requirements for the IFU and information provided with a device, including product labelling, are detailed in Essential Principle 13 of the Medical Device Regulations.

Post-market monitoring and standard conditions of inclusion

All sponsors of self-tests included in the ARTG have ongoing responsibilities under the Act, the Medical Device Regulations and the Therapeutic Goods Advertising Code, including conditions that apply automatically to all ARTG entries as described in the Australian Regulatory Guidance for Medical Devices. 

These conditions facilitate post-market monitoring and include, but are not limited to, the following:

• allowing entry and inspections of premises

• delivery of device samples upon request

• availability of information, such as facilitating access to technical documentation that demonstrates compliance with the Essential Principles

• ensuring any advertising material relating to the medical device complies with regulatory requirements; and

• reporting details of certain incidents and performance issues to the TGA, and any overseas regulatory actions to the TGA if the product involved is from the same batch or production run that was supplied in Australia.

All sponsors are also required to report adverse events to the TGA.

The TGA may impose additional conditions

Depending on the performance of the test, the information provided in the IFU and robustness of the test, the TGA may impose additional non-standard conditions to mitigate any residual risk identified relating to the effective and safe use of the product or to facilitate the monitoring of potential trends. 

These are likely to include a requirement that the sponsor:

• provide additional support for users of the test through provision of information that will direct users to on-line support services or 24/7 phone line

• provide the TGA with regular annual reports on the distribution of the product, numbers of tests sold and numbers of any reported false positive or false negative results or problems with poor performance of the test in Australia and worldwide (this may be a combination of monthly and annual reporting requirements)

• may potentially only supply the device through specified distribution channels that allow relevant information and education to be provided to users at the time of purchase. We will consider this case-by-case, depending on what risks need to be mitigated.

We may impose additional conditions case-by-case depending on our evaluation of the individual product, the overall benefits, and how well any risks have been mitigated.

Post-market review

We can conduct post-market reviews of devices included in the ARTG to verify their ongoing compliance with applicable regulatory requirements. Sponsors and manufacturers have continuing obligations after inclusion in the ARTG to ensure their devices continue to meet the applicable safety, quality and performance requirements throughout the product lifecycle.

ARTG entries for chlamydia, gonorrhoea or syphilis self-tests may also be subject to a post‑market review and sponsors may be asked to provide samples of test kits for independent laboratory evaluation of the clinical sensitivity and specificity to verify their performance.

• Regulation (EU) 2017/746 - Regulation - 2017/746 - EN - IVD - EUR-Lex

• EU common specifications - Commission Implementing Regulation (EU) 2022/1107

• WHO Syphilis Rapid Diagnostic Test - TSS 6 - Syphilis rapid diagnostic tests 

• Australian STI management guidelines - syphilis

• WHO NG Rapid Diagnostic Test - TSS 25 - Rapid diagnostic tests to detect Neisseria gonorrhoeae antigen

• WHO CT Rapid Diagnostic Test - TSS 26 - Rapid diagnostic tests to detect Chlamydia trachomatis antigen