Lucira Health on Thursday announced the results of a pilot study that evaluated the company’s combined chlamydia and gonorrhea assays running on its at-home molecular testing platform, which operates without an instrument.
The current study follows a previously published study of over 350 clinical samples wherein the Lucira Chlamydia assay chemistry demonstrated 94% sensitivity and 99% specificity, with an overall accuracy of 98%, the firm said.
The ongoing study has tested more than 150 female participants with positive performance results for the integrated chlamydia and gonorrhea tests; the study 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," Dr. Deborah Dean, a professor at the University of California San Francisco who is leading the clinical trials, said in a statement.
With a 30-minute swab-to-result time and 98% accuracy, the point-of-care test improves "clinical practice to prevent and control both Chlamydia trachomatis and Neisseria gonorrhoeae sexually transmitted infections 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," Dr. Dean added.
