Navigation Links
FDA Clears the First Rapid Test to Detect Bacteria in Pooled Platelets
Date:11/17/2009

LAKE ZURICH, Ill., Nov. 17 /PRNewswire/ -- Fenwal, Inc., a global medical technology company focused on improving blood collection, separation, safety and availability, announced today that the U.S. Food and Drug Administration has cleared the Verax Platelet PGD® test as a quality control test to detect bacterial contamination in whole blood-derived, pooled platelets prior to transfusion. Fenwal is the exclusive global distributor of the test, which was developed by Verax Biomedical of Worcester, Mass.

The Verax Platelet PGD® test is the only rapid diagnostic test to receive FDA clearance for detecting bacteria in both pooled and single-donor platelets. The test can be performed in approximately 30 minutes and is designed for use in hospitals, cancer centers and other sites of care as a safeguard prior to transfusion.

Bacterial contamination in platelets is a serious threat to transfusion safety. More than 5 million platelet doses are transfused annually worldwide. Studies show that up to 1 in 2,000 doses may contain bacteria, which can cause a range of reactions, including death, especially in immune-compromised patients.

The international blood transfusion association AABB (www.aabb.org) issued an Association Bulletin in July 2009 stating that "after publication of data sufficiently robust to support application of an assay appropriate for use near the time of platelet issue, the current standard will be reappraised. At that time, AABB intends to promulgate an interim standard to require enhanced methods of bacterial detection in WBD platelets--either by specifically prohibiting the use of less sensitive methods such as pH or glucose, or by establishing a minimum sensitivity level for methods used to detect bacteria." The Verax Platelet PGD® test is an example of such an assay.

"Until now, there was no rapid test cleared by t
'/>"/>

SOURCE Fenwal, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. FDA Clears Advanced Test for Monitoring Metastatic Colorectal Cancer
2. FDA Clears ExAblate Fertility Enhancement Study in Women With Uterine Fibroids
3. FDA Clears the Pathwork(R) Tissue of Origin Test for Hard-To-Identify Tumors
4. U.S. Food and Drug Administration Clears Way for Multi-Center Clinical Trial of IDEV Technologies SUPERA Peripheral Stent
5. FDA Clears a Test for Ovarian Cancer
6. Private Investment Firm Czura Thornton Today Introduces Clearstone Central Laboratories as the Newest Member of the Czura Thornton Life Science Group
7. U.S. Food and Drug Administration Clears Alcatel-Lucent Remote Patient Monitoring Solution for Sale in the United States
8. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
9. Sixty-One Percent of Newly Diagnosed Parkinsons Disease Patients Do Not Receive Any Drug Treatment in the First Year of Diagnosis
10. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
11. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/27/2015)... -- Research and Markets ( http://www.researchandmarkets.com/research/rq47bp/global_pressure ... Pressure Relief Devices Market 2015-2019" report to their ... to grow at a CAGR of 4.41% over the ... Market 2015-2019, has been prepared based on an in-depth ... covers the Americas, and the APAC and EMEA; it ...
(Date:7/27/2015)... , July 27, 2015  QT Vascular Ltd., ... a global company engaged in the design, assembly and ... treatment of vascular disease, has entered into an agreement ... to US$13.14 million convertible bond investment. This funding will ... its growth to the next milestone. ...
(Date:7/27/2015)... July 27, 2015  Array BioPharma Inc. ... for the fourth quarter and full year ... call to discuss those results on Monday, ... Officer will lead the call. ... 464-3927Toll:(765) 507-2598Pass Code: 68380312 Webcast, including Replay ...
Breaking Medicine Technology:Global Pressure Relief Devices Market 2015-2019 with ArjoHuntleigh, Hill-Rom, Paramount Bed Holdings & Stryker Dominating 2QT Vascular Obtains Funding To Boost Growth Through Issuance of up to US$13.14 Million Convertible Bonds 2QT Vascular Obtains Funding To Boost Growth Through Issuance of up to US$13.14 Million Convertible Bonds 3
(Date:7/27/2015)... Church, VA (PRWEB) , ... July 27, 2015 ... ... and Compliance From Step One, **FDAnews Webinar**, Aug. 13, 2015 — 1:30 p.m. ... procedures are one of the first things FDA investigators will look at during ...
(Date:7/27/2015)... ... July 27, 2015 , ... Looking to brush up on all ... Blue Shield of New Jersey has enhanced its Dental webpage with new materials, including ... teeth. , “Horizon is committed to offering our 3.8 million members tools and ...
(Date:7/27/2015)... ... July 27, 2015 , ... Send Word ... and mobile collaboration, announced today the latest software release for its ... other feature enhancements. , This software release gives the widely used online application ...
(Date:7/27/2015)... ... July 27, 2015 , ... In an ongoing program ... to its options. Already an industry leader because of its use of iPad ... the latest successful trends in helping people to overcome addiction and live healthy, ...
(Date:7/27/2015)... NJ (PRWEB) , ... July 27, 2015 , ... Gary ... Jersey. Dr. Breslow is Founder and Medical Director of The Breslow Center in ... the face, breast, and body in Northern New Jersey. The Breslow Center also ...
Breaking Medicine News(10 mins):Health News:FDAnews Announces — Writing Effective Standard Operating Procedures: Ensure Quality and Compliance From Step One Webinar, Aug. 13, 2015 2Health News:FDAnews Announces — Writing Effective Standard Operating Procedures: Ensure Quality and Compliance From Step One Webinar, Aug. 13, 2015 3Health News:FDAnews Announces — Writing Effective Standard Operating Procedures: Ensure Quality and Compliance From Step One Webinar, Aug. 13, 2015 4Health News:Thinking about a Dental Check-up? Check out Horizon Blue Cross Blue Shield of New Jersey’s Enhanced Website for a Dental Download of Helpful Information 2Health News:Send Word Now Announces Release of New User Interface for its Award-Winning Mass Notification Service 2Health News:Hiking Adds Benefits to Recovery at Serenity Palms 2Health News:Hiking Adds Benefits to Recovery at Serenity Palms 3Health News:NJ Top Doc, Dr. Gary Breslow, has launched Zwivel; a New Online Cosmetic Consultation Service for Doctors and Patients 2
... rank facilities don,t take all measurements into account , TUESDAY, ... onto the U.S. News & World Report list ... in some measurements regarding heart failure, researchers say. , "If ... the areas of heart failure mortality and readmission, you should ...
... be done up to 21 hours later with milder heart ... Many people who arrive at hospital emergency rooms with chest ... angioplasty, even if an electrocardiogram (EKG) shows evidence of a ... no significant difference in key measures of heart damage and ...
... 1 Zimmer Holdings, Inc. (NYSE: ZMH ; SWX: ZMH) announced ... of September: , , , Thomas ... 11:30 a.m. Eastern Time; , Morgan Stanley Healthcare Unplugged ... Eastern Time; and , UBS Global Life Sciences Conference ...
... , , , ... Hospital has earned the U.S. Environmental Protection Agency,s (EPA,s) prestigious ... environmental protection. St. Anthony,s is the first hospital in Florida ... achieve this recognition. Buildings that receive the EPA,s ENERGY STAR ...
... CHSI Solutions Hotline Provides NRSIG Members Immediate Medical Assessment -- ... September 1, 2009, employees of Nevada Restaurant Self-Insured Group members injured ... assessment from a medical professional when they call the CHSI Solutions ... Hotline will be available to NRSIG members and their employees all ...
... , , , ... an operating subsidiary of WellPoint, Inc. (NYSE: WLP ) and one ... on diagnostic imaging that appear in the August 27, 2009 issue of the ... article "Exposure to Low-Dose Ionizing Radiation from Medical Procedures" reviews the ...
Cached Medicine News:Health News:Government Best Source for U.S. Hospital Data, Study Finds 2Health News:Sometimes Angioplasty Can Wait 2Health News:St. Anthony's Hospital Is First to Earn EPA'S ENERGY STAR(R) Symbol for Superior Energy Efficiency 2Health News:St. Anthony's Hospital Is First to Earn EPA'S ENERGY STAR(R) Symbol for Superior Energy Efficiency 3Health News:Nevada Restaurant Self-Insured Group Launches 24-Hour Injury Hotline on September 1 to Ensure Employee Safety 2Health News:American Imaging Management Reacts to New England Journal of Medicine Articles on Diagnostic Imaging 2
Bone Curette, 160 mm...
Bone Currettes...
London Endocervical Curette is a stainless-steel curette for obtaining endocervical samples with minimal effort....
...
Medicine Products: