Learn More
binx™ health io™ CT/NG Assay
The CT/NG Assay is a single patient, single-use cartridge for the qualitative detection of chlamydia (CT) and gonorrhea (NG). The assay is performed on the binx™ health io™ Instrument.
Supplier: binx™ 1.002.101
Description
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 the detection of chlamydia (CT), the sensitivity and specificity rates were 96.1% and 99.1%, respectively, in female vaginal swab samples, whereas in male urine samples, the sensitivity and specificity rates were 92.5% and 99.3%, respectively. Conversely, for gonorrhea (NG), female vaginal samples exhibited sensitivity and specificity rates of 100.0% and 99.9%, while male urine samples demonstrated rates of 97.5% sensitivity and 100.0% specificity.
- Fully automated, FDA-cleared, CLIA-waived, sample-in result-out assay performed in a self-contained cartridge utilizing ultra-rapid polymerase chain reaction (PCR) combined with proprietary electrochemical detection, enabling sensitivity and specificity equivalent to central lab performance
- Provides the ability to test and treat within a single patient visit to offer improved patient outcomes such as reduced patient anxiety, lower transmission rates, fewer patients lost to follow-up, reduced empirical treatment, and less likelihood of complications or adverse events
- It is an easy-to-use, desktop-sized instrument that can be operated by trained personnel in CLIA-waived settings
Specifications
Waived | |
Male Urine, Vaginal Swab | |
Diagnosic Test | |
Ready-to-Use (RTU) |
Chlamydia trachomatis, N. gonorrhoeae | |
High | |
Chlamydia Testing |
We continue to work to improve your shopping experience and your feedback regarding this content is very important to us. Please use the form below to provide feedback related to the content on this product.