Test, enable diagnosis, and treat in a single visit with the first and only FDA-cleared, CLIA-waived, point-of-care platform for CT/NG testing for males and females.
Sexually transmitted infections (STIs) are on the rise and testing pathways are struggling to keep up.
Traditional pathway
Sample sent to central reference laboratory
1-10 days
Treatment may be inappropriate, before leaving the clinic or patients may be lost to follow up
binx io pathway
Sample run on binx io point-of-care test
~30 mins
Increases treatment compliance with same visit test and treatment [1]
The FDA-cleared, CLIA-waived, binx io platform uses ultra-rapid polymerase chain reaction (PCR) amplification in conjunction with our proprietary electrochemical detection to achieve sensitivity and specificity on par with central lab performance. [2]
Clinical performance measured against three FDA-cleared standard-of-care molecular platforms
Target | Sensitivity | Specificity |
---|---|---|
Chlamydia | 96.1% | 99.1% |
Gonorrhea | 100.0% | 99.9% |
Target | Sensitivity | Specificity |
---|---|---|
Chlamydia | 92.5% | 99.3% |
Gonorrhea | 97.3% | 100.0% |
Female | Male | |||||
---|---|---|---|---|---|---|
Target | Sensitivity | Specificity | Sensitivity | Specificity | ||
Chlamydia | 96.1% | 99.1% | 92.5% | 99.3% | ||
Gonorrhea | 100.0% | 99.9% | 97.3% | 100.0% |
2,445 person (1,523 females; 992 males) multi-center clinical study As published in JAMA Network Open Van Der Pol, B. et al. Evaluation of the Performance of a Point-of-Care Test for Chlamydia and Gonorrhoea. JAMA Network Open 3(5) (2020): e204819
Featured in Published Literature
The binx io is recognized in the industry for revolutionizing STI diagnostic testing at the point-of-care. We’re featured in published medical journals for our technological advances.
Learn how the binx io is transforming diagnostics with rapid results at the point-of-care
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The binx health io CT/NG Assay has been cleared by the United States Food and Drug Administration (FDA) 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.
The binx io system may not be available in all global geographies.
In April 2019, the binx health io CT/NG Assay received CE-marking for both female vaginal swab and male urine samples.
Intended Use (US):
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.
Intended Use (EU IVDD CE Mark):
The binx health io CT/NG Assay, when tested using the binx health io instrument is intended for use in point-of-care or clinical laboratory settings for the rapid qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) DNA in female vaginal swab and male first-catch urine specimens to aid in the diagnosis of symptomatic or asymptomatic infection with Chlamydia trachomatis and/or Neisseria gonorrhoeae.
[1] Kemp, L. (2022, Sep 20). Implementation of a "Test and Treat" model for Chlamydia trachomatis and Neisseria gonorrhoeae infection at Planned Parenthood Keystone [Conference Presentation]. CDC STD Prevention Conference, Online.
[2] Van Der Pol B, Taylor SN, Mena L, et al. Evaluation of the performance of a point-of-care test for chlamydia and gonorrhea. JAMA Netw Open 2020;3(5):e204819.