5/13/2010
Northwood, Ohio, May, 2010 – NAMSA is expanding its in vitro
testing capabilities to now include the Kinetic-Turbidimetric
Limulus Amebocyte Lysate (LAL) method. The Kinetic-Turbidimetric LAL
provides quantitative detection of endotoxin levels that is important
for predicting pyrogenic responses within various production processes,
quality water systems and lot release of products. (Pyrogens are
fever-producing materials that originate from gram-negative bacterial
cell walls, referred to as bacterial endotoxin, that are readily
detected by LAL testing.)
Currently, NAMSA offers the Kinetic Chromogenic and Gel Clot
methods. But the addition of the turbidimetric method into NAMSA's toxicology
offering should give clients more options in order to get their
products to market faster.
"The addition of the turbidimetric method provides us with a complete
LAL offering to better serve our clients and their diverse product
lines," said Dr. John Muraski, In Vitro Toxicology Manager at
NAMSA's Irvine Laboratory. "This enhances NAMSA's testing flexibility,
allowing us to test products or extracts that may interfere with the
Kinetic Chromogenic LAL reaction."
The turbidimetric method is typically used for tissue-containing
products, plasma, serum, products that contain protein or other products
that may cause interference with the chromogenic reaction (i.e.
colorant or dye in the material extract). Each time a new
device/product is developed or experiences a significant change in the
material formulation, LAL testing must be performed.
NAMSA follows the U.S. FDA, USP and AAMI guidelines when performing
all LAL tests.
To view a complete list of NAMSA's capabilities for all LAL testing, go to http://www.namsa.com/clients/fee-schedule.aspx.
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About NAMSA
NAMSA is a global contract research organization providing a
comprehensive range of services to prove efficacy, preclinical and
clinical safety of medical devices and combination products. For more
than 40 years, NAMSA clients have utilized its medical device testing
and consulting services to bring safe and effective therapies to market.
Contact Information
For further information about NAMSA or this news release, contact:
Andrew Gottfried
Product Manager
P 419.662.4458
F 419.662.4802
agottfried@namsa.com
www.namsa.com
