The binx health io CT/NG Assay has been cleared by the United States Food and Drug Administration for use with female vaginal swab specimens, collected either by a clinician or self-collected by a patient in a clinical setting, or male urine specimens.
In April 2019, the binx health io CT/NG Assay received CE-marking for both female vaginal swab and male urine samples.
io®, the io Instrument®, and the io Cartridge® (together the “io Diagnostic System®”) are registered trademarks of binx health limited. Copyright © 2020 binx health, inc. The binx health io CT/NG Assay, when tested using the binx health io Instrument, is a fully automated, rapid, qualitative test intended for use in point-of-care or clinical laboratory settings for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA by polymerase chain reaction. The binx health io CT/NG Assay is intended for use with female vaginal swab specimens, collected either by a clinician or self-collected by a patient in a clinical setting, or male urine specimens, as an aid in the diagnosis of symptomatic or asymptomatic Chlamydia trachomatis and/or Neisseria gonorrhoeae infection. For a symptomatic male patient with a chlamydia negative test result, further testing with a laboratory-based molecular test is recommended.
¹ The U.S. Centers for Disease Control and Prevention (2018). 2018 SEXUALLY TRANSMITTED DISEASES SURVEILLANCE REPORT. Updated August 27, 2019. https://www.cdc.gov/std/stats18/default.htm.
²,³ Huang W, Gaydos CA et al (2012). Comparative effectiveness of a rapid point-of-care test for detection of Chlamydia trachomatis among women in a clinical setting. STI. 88. Published first online 14 Sept 2012. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3671871/