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FDA Clears Chlamydia and Gonorrhea Test

The FDA approved Digene Corpora-tion'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.



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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


New Lab Test Rules Out Myocardial Infarction

The FDA has approved a new laboratory blood test that will significantly increase health care practitioners' ability to rule out myocardial infarction when a patient arrives at the emergency department with severe chest pains. The test is the first new blood test for evaluation of myocardial infarctions since the introduction of the troponin blood test in 1994.


The new test, the Albumin Cobalt Binding (ACB) Test, works by measuring how much cobalt is bound to the blood protein albumin. The test is intended for use with an electrocardiogram (ECG) and a blood test for troponin. The ACB test is a product of Ischemia Technologies, Denver, Colo.


The FDA approved the test based on the results of a study of more than 200 patients at high risk of myocardial infarction who had severe chest pain. Sixty-three percent of the patients had myocardial infarctions. The ACB test helped to identify the patients who did not have myocardial infarctions.


When the ACB test was used together with an ECG and a troponin test, health care providers were 70% accurate in ruling out myocardial infarction. With an ECG and troponin test alone, they were just 50% accurate in ruling out myocardial infarction.


Device Accelerates Soft Tissue Healing

BioElectronics Corporation, Frederick, Md., has been granted marketing approval for a new device that significantly accelerates soft tissue healing. The product (presently unnamed) delivers pulsed electromagnetic therapy in a disposable, wearable patch.


According to BioElectronics, while pulsed electromagnetic energy has been used for decades to effectively treat soft tissue injuries, traditional machines are large, cumbersome, and too expensive to be used as widely as needed. The company's coin-sized patch can go directly on the wound, instantly and inexpensively delivering therapy to the injured area. The small patch will emit the equivalent pulsed electromagnetic field therapy of a traditional refrigerator-sized device.


For surgical applications, the company notes, the new patch will speed recovery, permitting a faster hospital discharge, and reduce the risk of postoperative wound infections.


Suture Available with Antibacterial Agent

ETHICON Products, Somerville, N.J., has received FDA approval to market VICRYL Plus Antibacterial Suture, designed to reduce bacterial colonization. Vicryl Plus Antibacterial Suture is the first and only suture designed with an antibacterial agent, and is effective against Staphylococcus aureus, S. epidermidis, and methicillin-resistant strains of Staphylococcus (MSRA and MRSE).


The antibacterial coating begins working the moment it comes into contact with the patient by creating an "active zone" around the suture.


The suture is absorbable and should not be used where extended approximation of tissue under stress is required. The suture should not be used in patients with known allergic reactions to Irgacare MP (Triclosan).


Chest Pain Screening Test Approved

Biosite, San Diego, Calif., has received FDA approval to market the Triage Cardio ProfilER as an aid in the diagnosis of myocardial infarction, assessment of the severity of congestive heart failure, and for the risk stratification of patients with acute coronary syndromes.



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According to Biosite, the new test complements the company's Triage Cardiac Panel and Triage BNP Test by providing emergency department clinicians with a diagnostic test that can help them quickly and accurately evaluate suspected cases of acute coronary syndromes and congestive heart failure.


Antiseptic Skin Prep in One Step

Medi-Flex, Inc., Overland Park, Kans., received FDA approval for its commercial antiseptic ChloraPrep One-Step Sepp applicator (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) as a skin preparation for surgical sites and for venipuncture.


The new product was designed to be an effective way to prevent catheter-related bacteremia.


According to Medi-Flex, ChloraPrep has proven to significantly reduce the number of microorganisms on intact skin, and is the only antiseptic that meets new recommendations for skin antisepsis published by the U.S. Centers for Disease Control and Prevention.


In clinical trials, a one-step application of ChloraPrep exceeded the FDA's criteria for efficacy. Many facilities have chosen ChloraPrep as their current antiseptic for site preparation and care in order to facilitate "best practice." Not only is ChloraPrep effective and persistent in the elimination of bacteria, it is also easy on the skin. A comparative clinical study demonstrated that ChloraPrep was less irritating than PVP-I.



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The 0.67-mL Sepp Applicator is designed for hands-off aseptic application to smaller areas.


Studies show that ChloraPrep is long lasting and effective in killing a broad spectrum of microorganisms on the skin. One 30-second application of ChloraPrep kills bacteria for more than 48 hours.