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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.

The binx health io CT/NG Assay System (the "binx io System", "binx io CT/NG Assay" or "the System") is a rapid qualitative in vitro diagnostic system consisting of the following: 1. The binx io Instrument for running the Cartridge (the "Instrument") 2. The binx io CT/NG Cartridge (the "CT/NG Cartridge", "Cartridge" or "Cartridges"), that contains all the necessary reagents to perform the binx io CT/NG Assay (the "Assay") on the binx io Instrument 3. A single-use, fixed-volume transfer pipet (packaged with the Cartridge) for transferring the sample to the Cartridge 4. A Male Urine Collection Kit consisting of sample Collection tube containing preservation medium and a transfer pipet (the "Male Urine Collection Kit") All reagents are contained in the Cartridge as a combination of liquid reagents in blister packs and dried reagents. The Instrument is a small, desk top, fully-integrated instrument that uses air pressure to open and close valves on the binx io CT/NG Cartridge which, in turn, controls the movement of solutions within the Cartridge; the Instrument takes full control of the Cartridges once they are inserted, and no further user interaction is required. The operation of the Instrument is designed to be simple and intuitive; a user follows simple instructions on the graphical user interface (GUI) screen to load the Cartridge onto the Instrument with no further interaction required. The Male Urine Collection Kit consists of a tube containing a small volume of preservative medium and a Urine Transfer Pipet. To obtain a sample suitable for use on the CT/NG Cartridge, a 20-30 mL first-catch urine sample is collected by a patient in a suitable sterile vessel. The Urine Transfer Pipet provided with the Male Urine Collection Kit is used to transfer a sufficient volume of urine (nominally 4 mL in 2x 2 mL steps) into the collection tube such that the total volume falls between the two indicated lines on the collection tube. Once a sample has been correctly collected, the required sample volume (0.5 mL) is transferred from the sample collection tube to the Cartridge using the Sample Transfer Pipet provided with the Cartridge. The Cartridge has a visual sample addition indicator window which turns from light to dark to show the user that a sample has been added to the Cartridge. The Cartridge has three main Assay steps: sample preparation to isolate and purify target DNA; ultra-rapid polymerase chain reaction (PCR), which amplifies specific regions of DNA from the target organisms; and a proprietary electrochemical detection method to identify the presence of amplified DNA. When the specimen is added to the Cartridge, it is automatically mixed with a lysis solution to disrupt the cells present and release DNA which also rehydrates the Internal Process Control (IPC) sample. DNA extraction takes place and the eluted DNA is transferred to a homogenization chamber. The DNA in solution is transferred into two separate amplification chambers and reconstitutes the dried PCR reagents as it enters the chambers which are located over the Instrumentcontrolled PCR heater. Ultra-rapid PCR is carried out using sequence-specific primers for CT, NG (two separate genomic targets) and the IPC. Following amplification, the amplified target DNA is transferred from each PCR chamber into two separate detection chambers (four detection chambers in total) which contain a carbonbased screen-printed electrode. When the target is present and amplified, the target-specific probes and amplicon hybridize. The electrochemical labels are cleaved using a double-strand specific exonuclease. The cleaved electrochemical label diffuses to the electrode surface generating an electrical current that can be measured at a distinct voltage in nano Amps (nA) for each electrochemical label used. The presence of a measurable peak to a fixed cut-off parameter for each target returns a qualitative result without the need for any user interpretation or calculations.