Work by RI-MUHC postdoc Angela Karellis published in The Lancet Microbe will impact worldwide guidelines for rapid multiplexed testing
Multiplexed rapid technologies are moving into the limelight. A welcome advance in context of the COVID-19 pandemic, they make it possible for patients to visit their clinics just once to be tested for multiple pathogens and receive same-day results. Strategic deployment of rapid antigen/antibody and molecular RNA/DNA testing can equip low- and high-resource countries to step up testing and optimize treatment programs for many prevalent sexually transmitted infections (STIs).
Work published recently in The Lancet Microbe by scientists at the Research Institute of the McGill University Health Centre (RI-MUHC) can inform normative guidance of international agencies like Health Canada, the World Health Organization (WHO) and the Foundation for Innovative New Diagnostics (FIND), a Geneva-based global alliance.
“Our newly published results can help a wide range of stakeholders, from physicians and nurses in a clinic who conduct STI testing to policy makers and funders who draft guidelines and fund projects.”
— Angela Karellis, PhD
“Ours is the first systematic review in the field of multiplexed rapid STI testing technologies,” says postdoctoral fellow Angela Karellis, PhD, first author on the paper. “Prior to conducting this project, we noticed a gap in the literature in the field of STI diagnostics. No systematic review had yet examined the diagnostic accuracy of commercialized multiplexed rapid technologies, both molecular and serological. Our newly published results can help a wide range of stakeholders, from physicians and nurses in a clinic who conduct STI testing to policy makers and funders who draft guidelines and fund projects.”
For individuals who have yet to use these types of technologies, the review serves as an orientation to what is commercially available and the pathogens these devices are able to detect. “While multiplex testing has been around for a few years, the COVID-19 pandemic has accelerated the need to screen for multiple pathogens simultaneously,” Angela Karellis notes. “Hence, this work is extremely relevant right now.”
First study author and postdoctoral fellow Angela Karellis, PhD (left), and her supervisor Nitika Pant Pai, MD, MPH, PhD (right), a scientist in the Infectious Diseases and Immunity in Global Health Program at the Research Institute of the MUHC
The research team was led by Dr. Nitika Pant Pai, a scientist in the Infectious Diseases and Immunity in Global Health Program at the RI-MUHC and associate professor in the Department of Medicine, Division of Clinical Epidemiology, McGill University. “We set out to provide evidence that can help improve integrated rapid screening STI initiatives, antimicrobial stewardship, and disease elimination of key pathogens,” says Dr. Pant Pai. “We asked the question: What is the real-world diagnostic performance of all rapid multiplexed technologies for many sexually transmitted infections?”
High accuracy in field settings
Across 26,216 individuals, spanning 19 sexually transmitted infections detected by rapid multiplex test devices, the authors found that most technologies (rapid immunochromatographic tests and rapid nucleic acid amplification test platforms) yielded more than 95% sensitivity and specificity. As no restrictions were set on the type of STI evaluated, they present evidence from more commonly known pathogens to others less frequently discussed, such as chlamydia, gonorrhea, human immunodeficiency virus (HIV), syphilis, herpes-simplex virus, and hepatitis B (HBV). Accuracy findings are presented along with the reference standard test used, specimen type and 95% confidence intervals, for a full picture of the results.
“These findings are important because they show that multiplexed rapid technologies, whether larger benchtop platform devices or handheld immunochromatographic tests, can be highly accurate – over 95% – in field settings. Therefore, these technologies can be advised for screening and confirmatory use. This makes the case for their greater deployment across low-, middle- and high-income settings,” says Angela Karellis.
Return to disease elimination agendas
The authors expect this first systematic review of real-world findings to help leverage multiplexed rapid technologies to meet a growing demand for screening and expedite disease elimination agendas.
“These disease elimination agendas will be relevant once the COVID-19 wave ebbs and neglected programs resurrect to meet them – including programs for HIV, HCV, HPV, HBV, chlamydia and gonorrhea,” explains Dr. Pant Pai. “The review provides data to improve access to screening for individuals who can’t show up for facility-based testing. It provides the evidence base for rapid screening solutions for active surveillance, identifying people with high sexually transmitted infection risk and enabling time-saving, rapid multiplexed simultaneous screening for many related pathogens. It is useful for patients, providers, and health-care systems,” concludes Dr. Pant Pai. “We look forward to seeing further work that evaluates real-world impact in high-risk populations, both nationally and internationally.“
About the study
Read the publication in The Lancet Microbe.
The authors gratefully acknowledge support from the CIHR and ICIMPACTS, who funded the work.
The authors thank the Containment Level 3 Platform of the RI-MUHC.
Learn more about Dr. Nitika Pant Pai’s research on her website.