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Rapid, Accurate Test Results in ~30 minutes
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.
Together, we can help stop the spread
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 power of a central lab at the touch of a button
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]
Clinically-Proven, FDA-Cleared
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
binx io Brochure
binx io Clinic Workflow
binx io Asymptomatic / Symptomatic Brochure
binx io Vaginal Swab Specimen Collection Kit Instructions for Use
binx io Male Urine Specimen Collection Kit Instructions for Use
binx io Instrument Instructions for Use
binx io CT/NG Assay Instructions for Use - CLIA Waived
binx io CT/NG Assay Quick Reference Guide
binx io Export Instructions for io Instrument
binx io CT/NG Assay Safety Data Sheet
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.
How it works
Learn how the binx io is transforming diagnostics with rapid results at the point-of-care
Ready to Bring STI Testing to Your Community?
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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.