binx™ health io™ CT/NG Assay

Description

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.

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

• Clia Complexity: Waived
• Detectable Analytes: Chlamydia trachomatis, N. gonorrhoeae
• Sample Type: Male Urine, Vaginal Swab
• Sensitivity: High
• Type: Diagnosic Test
• For Use With (Application): Chlamydia Testing
• Form: Ready-to-Use (RTU)