Lucira Health, a medical technology company, announced interim results of a pilot study to evaluate the performance of their combined Chlamydia trachomatis and Neisseria gonorrhoeae assays integrated into the instrument-free at-home Lucira molecular test platform for STI testing.
The development of these assays is supported by several grants from the National Institutes of Health with professor Deborah Dean, MD, MPH, at UC San Francisco. This current study follows a previously published study of over 350 clinical samples where the Lucira Chlamydia assay chemistry demonstrated a performance of 94% sensitivity and 99% specificity, with an overall accuracy of 98%1. The ongoing study has tested over 150 female participants with positive performance results of the integrated chlamydia and gonorrhea tests and will be published in the near future.
“We developed a rapid point of care test (POCT) which uses Lucira Health’s loop-mediated amplification (LAMP) of nucleic acids, and performed a double blind, head-to-head comparison with the Cepheid Xpert CT/NG assay using clinician-collected de-identified paired vaginal samples. These samples were collected from symptomatic and asymptomatic females aged 18 years and older who were attending the Ministry of Health and Medical Services Health Centers in Fiji,” says Dean. “With a 30-minute swab-to-result time and 98% accuracy, our POCT is a game changer for improving clinical practice to prevent and control both Chlamydia trachomatis and Neisseria gonorrhoeae sexually transmitted infections (STIs) in diverse health care settings globally. With the hand-held device already widely accepted by the consuming public, we anticipate an increase in widespread use inside clinics and at home.”
Lucira is integrating these STI assays into its easy-to-use fully untethered test platform that requires no external equipment and produces rapid molecular results on-the-spot.
“It’s an honor to have world renowned principal investigator, Deborah Dean, MD, MPH, leading the clinical trials for Lucira’s chlamydia and gonorrhea assays,” says Debkishore Mitra, PhD, Chief Technology Officer and Co-Founder at Lucira Health. “With STI numbers growing globally each year, Lucira’s vision is to build these new assays into our existing lab-quality tests to be used at home and empower both consumers and clinicians with a collaborative, easy approach to getting more accurate and faster results. The level of accuracy achieved in these results continues to show this technology platform can bring world-class diagnostics that are faster, easier, and more flexible to help in this mission of healing.”
Chlamydia and gonorrhea infections total over 2.2 million cases annually in the United States, have been increasing each year, and represent a larger burden globally, according to the CDC. The majority of female infections are asymptomatic and, as a result, the U.S. Preventative Services Task Force recommends annual screening of sexually active women 25 years of age or younger. This translates into potentially 20 million screening tests per year, a significant opportunity to support surveillance testing both in point of care and home testing.
1 Dean, Deborah, et al. “Development and evaluation of a point-of-care test in a low-resource setting with high rates of Chlamydia trachomatis urogenital infections in Fiji.” Journal of clinical microbiology 59.7 (2021): e00182-21.