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Conference and Trade Show Schedule March
30 – April 1, 2008
American
Association of Tissue Banks (AATB) 12th
Annual Spring Meeting Savannah, Georgia
April
9 – 13, 2008 Pacific
Coast Reproductive Society (PCRS) 56th
Annual Meeting Rancho Mirage, California
April
27 – 30, 2008
Clinical
Virology Symposium (CVS) 24th
Annual Clinical Virology Symposium Daytona Beach, Florida
May 14 – 16, 2008 American
Society for Clinical Laboratory Science (ASCLS-MN)
Spring Clinical Laboratory Collaborative
2008 Saint Paul, Minnesota
June
4 – 7, 2008 Eye
Bank Association of America (EBAA) 47th
Annual Meeting Hollywood, Florida
July 29 – August 2,
2008 American
Society for Clinical Laboratory Science (ASCLS)
Annual
Meeting 2008
Washington,
D.C.
September
6 – 9, 2008 American Association of Tissue Banks
(AATB) 32nd Annual
Meeting Chicago, Illinois
November
8 – 12, 2008 American Society for Reproductive Medicine
(ASRM)
64th Annual Meeting
San Francisco, California FDA Releases Guidance for Donor Eligibility Testing August 2007 – The Food and Drug Administration (FDA) released its Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). This document is available online at http://www.fda.gov/cber/gdlns/tissdonor.htm. The federal guidance assists establishments in complying with donor eligibility determinations as set forth in Title 21 Code of Federal Regulations, part 1271, subpart C. This guidance applies to cells and tissues procured on or after May 25, 2005. The most significant change from previous guidance is the requirement of nucleic acid testing (NAT) for HIV-1 and HCV. Additionally, NAT testing has tighter specimen viability requirements than serology testing. Direct Shipping System Now Available for Reproductive Donor Eligibility Testing Performed at ViroMed
June
2007 – ViroMed
Laboratories, Inc., has introduced a direct shipping system for
time-sensitive specialty testing performed at their laboratories. The direct shipping system can
assist in ensuring timely receipt of specimens for infectious disease
testing such as donor eligibility screening that must be performed
according to U.S. Food and Drug Administration (FDA) guidance. ViroMed is an FDA-registered
laboratory for human cells, tissues, and cellular- and tissue-based
products (HCT/Ps).
Click here for ViroMed direct shipping system details and ordering information New Donor Testing Panels
June
2007 – For
customer convenience, ViroMed has created ten new donor test panels that
include recommended testing (http://www.fda.gov/cber/gdlns/tissdonor.htm),
including HIV-1/HCV NAT and CT/NG.
Four of the new panels cover basic testing requirements, and six
cover special needs. Use of
these panels is recommended to allow for easier direct shipping (when
necessary) and to assist clients in maintaining records of infectious
disease testing.
Click here for a list of the new panels Additional Specimens Allowed for HSV Testing
June 2007 – ViroMed now accepts whole blood, serum, and plasma specimens for Herpes Simplex Virus (HSV) Types I/II, DNA by PCR (138651) testing in addition to swabs, tissue, and fluids. This assay detects HSV-1 and HSV-2 DNA in clinical specimens and, when performed on cerebrospinal fluid, supports a diagnosis of herpes simplex encephalitis and herpes simplex meningitis. Newsletters Cell Culture Bulletin Volume 2 (2007)
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