Doherty Institute researchers unveil an assay that identifies four STIs and antibiotic resistance in under an hour with up to 100% precision.
Researchers at the Peter Doherty Institute for Infection and Immunity in Australia have developed a portable, point-of-care diagnostic tool capable of detecting four major sexually transmitted infections (STIs) simultaneously in under 60 minutes, according to a recent press release.
The device, a next-generation CRISPR-based diagnostic, identifies DNA and RNA for syphilis, herpes simplex virus (HSV), chlamydia, and gonorrhea. Notably, the test also detects a critical antibiotic-resistance marker in gonorrhea, providing a vital tool in the global fight against antimicrobial resistance.
Closing the Diagnostic Gap
The clinical challenge of STIs often lies in their “mimicking” nature, meaning many infections present with nearly identical symptoms, such as genital sores, but require distinct treatment protocols. Without rapid testing, clinicians are often forced to treat based on symptoms alone, leading to potential misdiagnosis.
“Syphilis has long been known as the great mimicker. Correct treatment depends on correct diagnosis,” said Shivani Pasricha, PhD, laboratory head at the Doherty Institute and senior author of a related study published in The Lancet Microbe. “This novel tool enables accurate diagnosis and treatment immediately, without waiting days for laboratory testing or requiring multiple clinic visits.” (Photo credit: Doherty Institute)
Proven Precision
The device has undergone extensive validation, using 900 clinical samples—the largest set ever reported for a CRISPR-based point-of-care device.
“When benchmarked against gold-standard laboratory PCR, the rapid test showed 97–100% accuracy in correctly identifying negative results, a level of precision important for safe, evidence-based treatment decisions,” stated Matthew O’Neill, research support officer at the Doherty Institute and co-first author.
The researchers are now moving toward implementation trials, with a goal of integrating the device into routine clinical use within the next five years.
Overall decline: The combined total of chlamydia, gonorrhea, and syphilis cases fell by 9% compared to 2023, marking the third consecutive year of decline. Despite this, the US still recorded over 2.2 million total infections in 2024.
Syphilis trends:
Primary and secondary syphilis: These highly infectious stages saw a significant 22% decrease from 2023.
Congenital syphilis: In a distressing trend, cases of syphilis passed from mother to child increased for the 12th consecutive year, with nearly 4,000 cases reported in 2024. This represents a nearly 700% increase over the last decade.
Chlamydia and gonorrhea:
Chlamydia cases dropped by 8% from 2023.
Gonorrhea cases declined for the third year in a row, falling by 10%.
Long-term Perspective
While recent years show improvement, the overall STI burden remains 13% higher than it was a decade ago, highlighting the urgent need for the rapid, accessible diagnostic technologies currently being developed by teams like those at the Doherty Institute.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
WHO is developing its first global guidelines on multiplex testing for HIV, hepatitis, and STIs, offering lab leaders a framework to optimize diagnostics, streamline workflows, and lead the shift toward integrated, multi-disease testing.
As diagnostic technologies rapidly evolve and healthcare systems shift toward integrated service delivery, laboratory leaders are at the forefront of implementing efficient, multi-disease testing strategies.
In a landmark move, the World Health Organization (WHO) has convened a Guideline Development Group (GDG) to develop its first-ever evidence-based recommendations on multiplex testing, a method that enables simultaneous detection of HIV, viral hepatitis, and STIs from a single sample. This initiative will establish foundational principles for integration, resource prioritization, and diagnostic efficiency, offering lab professionals critical guidance to shape the future of testing across diseases.
The GDG, comprised of international experts and stakeholders, will provide evidence-based recommendations to support integrated, people-centered diagnostic strategies.
As global health systems shift toward more integrated service delivery, multiplex testing is emerging as a practical tool for increasing diagnostic access, streamlining care, and maximizing limited resources, particularly in low- and middle-income countries, where testing gaps remain significant.
“Access to timely and accurate diagnostic testing is essential for the prevention, detection, and management of HIV, viral hepatitis and STIs,” WHO stated in its announcement. “Multiplex testing has emerged as a promising strategy to improve efficiency, expand testing coverage across diseases, and enhance cost-effectiveness.”
A First-of-Its-Kind Guideline
This is the first WHO guideline to explicitly address multiplex testing using the most up-to-date evidence. While the focus will be on HIV, viral hepatitis, and STIs, the guidelines aim to establish critical principles for integration that can be extended to other disease areas over time.
“This guideline will provide critical principles for integration that drive public health impact and chart the course for further multi-disease testing approaches,” WHO noted.
Photo credit: “World Health Organization Flag” by United States Mission Geneva is licensed under CC BY 2.0. To view a copy of this license, visit https://creativecommons.org/licenses/by/2.0/?ref=openverse.
The GDG will address both provider-based testing and self-testing, recognizing the growing role of community-led and patient-driven diagnostics. Key issues on the agenda include how to prioritize limited testing resources, ensure quality assurance, and optimize public health outcomes through integrated diagnostic models.
Guideline Development Group: Global, Inclusive, Independent
The GDG is composed of members from all WHO regions, selected based on their technical expertise, field experience, and perspectives as either implementers or members of affected communities. Importantly, all members participate in their individual capacities and not as representatives of any affiliated organizations.
“In accordance with WHO guidelines for developing recommendations, the GDG is composed of members from all WHO regions, serving in their individual capacities,” the organization explained. “Members do not receive financial compensation for their contributions to this process.”
The GDG includes program managers, healthcare providers, researchers, and community advocates, reflecting the full spectrum of stakeholders involved in diagnostic service delivery. Their diverse backgrounds are intended to ensure that the guidelines are evidence-informed, practical, and contextually relevant across settings.
A virtual meeting is scheduled for November 4-5, 2025, during which the group will discuss evidence, identify priority recommendations, and finalize key principles around multiplex testing and integration.
WHO Opens Public Comment Period
To promote transparency and inclusivity, WHO has opened a public comment period and is inviting feedback on the composition of the GDG. Stakeholders, organizations, and individuals can review member biographies and submit comments via email to hiv-aids@who.int by September 29, 2025.
The upcoming guideline represents a significant step in advancing integrated diagnostics and expanding access to care, particularly in resource-limited settings. By combining clinical evidence with real-world insights, WHO aims to provide countries and implementers with practical, scalable recommendations that improve testing coverage and disease detection at all levels of the health system.
As testing technologies evolve and the demand for multi-disease platforms grows, this guideline may serve as a blueprint for future diagnostic integration efforts, laying the foundation for efficient, patient-centered, and cost-effective care delivery worldwide.
