New Chlamydia and Gonorrhea Test
The Food and Drug Administration (FDA) approved Digene Corporation's high-volume sample throughput instrument application for Hybrid Capture 2 Chlamydia/Gonorrhea testing using its Rapid Capture System. The Rapid Capture System detects Chlamydia trachomatis (CT) DNA and Neisseria gonorrhoeae (GC) DNA in cervical specimens.
Through automated microplate processing, the Rapid Capture system allows increased throughput of Digene's Hybrid Capture 2 CT/GC Test.
The FDA approved the Digene HPV Test as an adjunct to the Papanicolaou test for cervical cancer screening, but not as a primary cervical cancer screen. More information is available at http://www.digene.com.
Skin Adhesive Offers Microbe Protection
The FDA has approved Ethicon's Dermabond Topical Skin Adhesive (2-octyl cyanoacrylate), which protects skin from bacterial microbes.
First approved in 1998, the product's labeling now states that the adhesive acts as a barrier to microbial penetration when the adhesive film remains intact. Dermabond's liquid adhesive closes surgical incisions and traumatic lacerations without sutures or staples. Use it in conjunction with, but not in place of, subcuticular sutures.
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In vitro studies found that Dermabond Adhesive was 99% effective in protecting against Staphylococcus epidermidis, Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa. and Enterococcus faecium.
The product is contraindicated for use on wounds with evidence of active infection or gangrene. Don't use it on mucosal surfaces, across mucocutaneous junctions, or on skin exposed to body fluids. For more information, visit http://www.dermabond.com.
Blocking Injection Pain
Bionix Development Corporation has introduced ShotBlocker, a plastic, single-use device that blocks the pain associated with injections. The ShotBlocker features a number of short, blunt skin contact points on its underside. Place the device on the patient's skin and administer the injection through Shotblocker's central opening.
ShotBlocker uses the gate control theory of pain management: When a gating mechanism in the spinal cord is open, small nerve fibers transfer pain signals to the brain. Simultaneous stimulation of large-diameter nerve fibers, which respond to touch, close the gate. ShotBlocker costs less than $1 each and come in boxes of 25 and 100. More information is available at 1-800-551-7096 or http://www.bionix.com.
Detect Sleep-Related Breathing Disorders
Itamar's Watch_PAT100 has received FDA approval for detecting sleep-related breathing disorders based on changes in an individual's peripheral arterial tone (PAT) signal. The PAT signal reflects arterial pulsatile volume changes in the fingertip, which is a reliable indicator of sleep-related breathing disorders such as obstructive sleep apnea.
Users wear the self-contained device on their wrists, and a noninvasive finger probe measures the PAT signal. A removable memory card records the signals, which you can download to a computer for automatic analysis. The Watch_PAT100 also records oxygen saturation, actigraphy, and heart rate.
The Watch_PAT100 offers an unattended, ambulatory, patient-friendly, diagnostic evaluation of sleep-related breathing disorders. For more information, visit http://www.respironics.com or http://www.itamar-medical.com.
Parathyroid Hormone Kit Approved
Quest Diagnostics has received FDA approval to market Bio-Intact PTH (1-84), a diagnostic test kit that measures parathyroid hormone (PTH). The kit operates on the Nichols Advantage platform, a fully automated benchtop chemiluminescence system.
The assay recognizes the entire parathyroid hormone molecule rather than molecule fragments, which tend to break up. By recognizing the entire PTH molecule, the new assay has specificity for the N-terminal region of PTH, which is essential for PTH's biologic effect. The test uses proprietary antibodies to bind to the first amino acids in the N-terminal region of the PTH 1-84 sequence. For more information, visit http://www.questdiagnostics.com.