Louise Causer

Background: Point-of-care hepatitis C virus (HCV) antibody and RNA testing can simplify diagnosis and improve treatment initiation compared to the standard-of-care HCV diagnostic algorithm, but its population-level health and economic effects when implemented at scale remain uncertain. The Australian Hepatitis C Point-of-Care Testing Program (National Program) is a real-world national program implementing across community and prison settings. We evaluated the epidemiological impact and cost-effectiveness of its current and future implementation. Methods: We used a dynamic deterministic model of HCV transmission and testing, with parameters informed by empirical implementation, epidemiological, and cost data from the National Program. Current implementation and future sustainment and scale-up scenarios was compared with a no-program counterfactual using standard-of-care HCV diagnostics across community and prison settings. Cost-effectiveness was assessed from the healthcare providers’ perspective over 2022-2041 to capture long-term costs and quality-adjusted life-years (QALYs) beyond 2022-2030 implementation period. Costs and QALYs were discounted at 5% per annum. Findings: Under sustained implementation to 2030, HCV RNA prevalence was projected to decline from 9·5% in 2021 to 2·4% in 2030, versus 3·3% without the Program. Compared with no program, sustained implementation was projected to avert 4,350 infections (13·7%) and facilitate 1,242 treatments (2·3%) over 2022-2030. Over 2022-2041, A$20·5 million in incremental diagnostic costs were offset by reductions in HCV treatment (A$19·9 million) and disease management (A$10·8 million), generating net savings of A$10·2 million and A$1·34 in return per A$1 invested. All scenarios remained cost-effective across sensitivity analyses; while sustained implementation scenario was no longer dominant when treatment price fell to 10% of the PBS-listed price. Interpretation: Sustained national point-of-care HCV testing across community and prison settings was projected to reduce HCV burden and generate long-term health-care savings, mainly through infections averted by treatment as prevention. These findings demonstrate that investment in targeted point-of-care testing infrastructure can deliver health and economic benefits.

Background: Gonococcal antimicrobial resistance (AMR) surveillance depends on phenotypic susceptibility testing of viable Neisseria gonorrhoeae isolates. However, diagnosis increasingly relies on nucleic acid amplification tests (NAATs), which detect gonococcal nucleic acid but do not yield viable isolates. We quantified culture recovery among NAAT-positive N gonorrhoeae infections and identified clinical and laboratory factors associated with recovery.Methods: We searched PubMed, Embase, Scopus, and Dimensions for studies and conference abstracts published between Jan 1, 2000, and May 7, 2026. Eligible studies reported data to calculate culture recovery among NAAT-positive N gonorrhoeae infections. Pooled recovery was estimated using random-effects meta-analysis and associated factors were assessed using random-effects meta-regression.Findings: We included 99 studies, contributing 251 study estimates. Overall pooled recovery was 54% (95% CI 50–59), ranging from 81% (76–85) for male urethral to 27% (23–30) for pharyngeal specimens. Recovery was 60% (47–72) among symptomatic infections and 40% (31–50) among asymptomatic infections. In multivariable meta-regression, compared with cervical specimens, recovery was lower for anorectal (β -0·10, 95% CI -0·17 to -0·02; p=0·014), pharyngeal (-0·36, -0·43 to -0·28; p<0·001), and vaginal specimens (-0·21, -0·34 to -0·08; p=0·001), and higher for male urethral specimens (0·17, 0·10 to 0·25; p6 h after specimen collection) was independently associated with lower recovery than immediate or ≤6 h plating (β -0·12, -0·23 to -0·01; p=0·038).Interpretation: Only about half of NAAT-positive infections yielded isolates, and recovery was strongly associated with anatomical site and the culture-specimen pathway. These findings show that culture recovery is not simply a laboratory outcome, but a selective infection-to-isolate pathway that determines which diagnosed infections become available for phenotypic antimicrobial resistance surveillance, which can limit the representativeness and bias the surveillance. Surveillance systems should optimise culture pathways, report transparent diagnostic-to-susceptibility denominators, and integrate molecular tools that complement culture. Funding : Australian National Health and Medical Research Council and the Australian Research Council Industrial Transformation Research Hub.

Objectives: In remote Australian First Nations communities, the burden of curable sexually transmitted infections (STIs) is highest for young women and men aged 16–29 years and for women is associated with two-fold higher rates of hospitalisations for pelvic inflammatory disease (PID) than for non-First Nations women. Following a randomised trial, decentralised community-led molecular point-of-care (POC) testing for STIs has operated in remote primary care across Australia for more than 7 years, improving uptake and timeliness of treatment for chlamydia, gonorrhoea and trichomonas infections. However, cost-effectiveness remains unknown. Methods: A decision analytic model was devised to compare costs and outcomes associated with a POC testing programme for chlamydia, gonorrhoea and trichomonas infections in women and men aged 16–29 years seeking care, compared with standard care (laboratory-based testing). The analysis used a government payer perspective and 10-year time horizon. The primary outcome was the cost ($A) per quality-adjusted life year (QALY) gained. Sensitivity analyses examined uncertainty around the results. Results: Based on a combined testing positivity rate of 36% and 29% for chlamydia, gonorrhoea and trichomonas for women and men, respectively, the POC testing programme, compared with laboratory testing, produced an estimated incremental cost per QALY ratio (ICER) of $A19 714 (95% CIs $A19 608 to $A19 821) over 10 years. Among those with an STI, the POC testing programme was predicted to reduce diagnosed PID by 30% and preterm/low birth weight babies by 17%. Sensitivity analyses indicated that the ICER was most sensitive to the probability of infection and receiving treatment within 2 days, based on a willingness-to-pay threshold of $A50 000. Conclusion: This health economic evaluation indicates that a scaled molecular POC testing programme for the management of STIs in remote primary care settings is cost-effective compared with standard care. Sustained POC testing in this setting is likely to improve reproductive health outcomes.

Objective: In remote Australia, where there is a substantial burden of sexually transmitted infections (STIs) among First Nations peoples, testing and timely treatment are key to reducing prevalence. We evaluated the impact of introducing molecular point-of-care (POC) testing for chlamydia/gonorrhoea and later trichomonas on STI testing (including syphilis) and positive tests. Methods: We conducted a retrospective interrupted time-series analysis of routinely collected data from First Nations peoples aged 15–54 years attending 20 remote/regional clinics participating in the Test, Treat and GO programme (2016–2019). We used segmented regression models to estimate the immediate level change (first month of POC) and after-period trends in monthly tests, positive tests and proportion of concurrent syphilis tests to assess sustainability. Before and after comparisons were estimated using linear regression models. Results: There were 17 437 chlamydia/gonorrhoea and 14 173 trichomonas tests performed, mostly among women (69% and 64%) and individuals aged 15–34 years (72% and 68%). Following the introduction of molecular POC testing, there were immediate level increases in monthly tests: chlamydia/gonorrhoea by 26% (+154, p<0.001) and trichomonas by 21% (+116, p=0.004) and level increases of positive tests: gonorrhoea by 30% (+13, p=0.017) and trichomonas by 29% (+14, p=0.034); chlamydia was unchanged. The proportion of chlamydia/gonorrhoea tests with concurrent syphilis tests remained unchanged (−1.7%; −0.9%; p=0.531), while the proportion increased among positive chlamydia/gonorrhoea tests by 25% (+13%; p=0.013). Increased levels of testing were sustained for gonorrhoea/chlamydia (+2.7, p=0.118) and trichomonas (−3.5, p=0.400) and syphilis among those with positive chlamydia/gonorrhoea tests (−0.2%, p=0.593). Conclusion: Molecular POC testing led to immediate and sustained increases in STI testing and an immediate increase in positive tests in remote primary care. The use of POC testing is likely to result in earlier diagnosis and treatment and reduced onward transmission and sequelae, supporting a broader integration of POC testing in high-burden settings.

This chapter provides a ‘how to guide’ to set up and manage a molecular-based point-of-care (POC) testing network to detect Chlamydia trachomatis (Chlamydia) in populations experiencing high burden of infection and sequelae as well as barriers to accessing routine laboratory services. The chapter outlines the experience of the Australian-based Test, Treat and Go (TTANGO) program which, to the authors’ knowledge, represents the largest decentralised POC testing network for chlamydia (as well as gonorrhoea and trichomoniasis) in the primary care sector globally. The chapter provides an overview of the program’s evolution from a randomised controlled trial through implementation, translation, and scale-up phases to a now national routine program with associated testing rebates. The chapter will examine the governance, training and quality management, and connectivity processes that underpin the TTANGO network and describe the clinical, cultural, operational and economic effectiveness of the network. Collectively, these elements provide a template for translation to low- and middle-income countries (LMIC) where Chlamydia trachomatis remains a significant contemporary health problem.

Objectives: To estimate notification rates for infectious syphilis in women of reproductive age and congenital syphilis in Australia.Study design: Retrospective cohort study; analysis of national infectious syphilis and enhanced congenital syphilis surveillance data.Setting, participants: Women aged 15–44 years diagnosed with infectious syphilis, and babies with congenital syphilis, Australia, 2011–2021.Main outcome measures: Numbers and rates of infectious syphilis notifications, by Indigenous status and age group; numbers and rates of congenital syphilis, by Indigenous status of the infant; antenatal care history for mothers of infants born with congenital syphilis.Results: During 2011–2021, 5011 cases of infectious syphilis in women aged 15–44 years were notified. The notification rate for Aboriginal and Torres Strait Islander women rose from 56 (95% confidence interval [CI], 45–65) cases per 100 000 in 2011 to 227 (95% CI, 206–248) cases per 100 000 population in 2021; for non‐Indigenous women, it rose from 1.1 (95% CI, 0.8–1.4) to 9.2 (95% CI, 8.4–10.1) cases per 100 000 population. The notification rate was higher for Aboriginal and Torres Strait Islander women than for non‐Indigenous women (incidence rate ratio [IRR], 23.1; 95% CI, 19.7–27.1), lower for 15–24‐ (IRR, 0.7; 95% CI, 0.6–0.9) and 35–44‐year‐old women (IRR, 0.6; 95% CI, 0.5–0.7) than for 25–34‐year‐old women, and higher in remote regions than in major cities (IRR, 2.7; 95% CI, 2.2–3.8). During 2011–2021, 74 cases of congenital syphilis were notified, the annual number increasing from six in 2011 to a peak of 17 in 2020; the rate was consistently higher among Aboriginal and Torres Strait Islander infants than among non‐Indigenous infants (2021: 38.3 v 2.1 per 100 000 live births). The mothers of 32 infants with congenital syphilis (43%) had not received antenatal care.Conclusions: The number of infectious syphilis notifications for women of reproductive age increased in Australia during 2011–2021, as did the number of cases of congenital syphilis. To avert congenital syphilis, antenatal screening of pregnant women, followed by prompt treatment for infectious syphilis when diagnosed, needs to be improved.

In April 2020, the Aboriginal and Torres Strait Islander COVID-19 Point-of-Care (POC) Testing Program was initiated to improve access to rapid molecular-based SARS-CoV-2 detection in First Nations communities. At capacity, the program reached 105 health services across Australia. An external review estimated the program contributed to averting between 23,000 and 122,000 COVID-19 infections within 40 days of the first infection in a remote community, equating to cost savings of between AU$337 million and AU$1.8 billion. Essential to the quality management of this program, a customised External Quality Assessment (EQA) program was developed with the Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP). From July 2020 to May 2022, SARS-CoV-2 EQA participation ranged from 93 to 100%. Overall concordance of valid EQA results was high (98%), with improved performance following the first survey. These results are consistent with those reported by 12 Australian and 4 New Zealand laboratories for three SARS-CoV-2 RNA EQA surveys in March 2020, demonstrating that SARS-CoV-2 RNA POC testing in primary care settings can be performed to an equivalent laboratory analytical standard. More broadly, this study highlights the value of quality management practices in real-world testing environments and the benefits of ongoing EQA program participation.