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File: 120396_sep96_decls71_0002.txt
Subject: TIPS ON CONDUCTING THE TEST
Unit: OTSG
Parent Organization: HSC
Box ID: BX003203
Folder Title: ANTHRAX PA ASSAY SMART TEST
Document Number: 1
Folder SEQ #: 24
jAN 30 '91 1 P.2
ornr)r-T
UNCLASSIFIED
SGRI)-UID-E 29 January 1591
MEMCRA-NDUM FOR Commander James Burans, Navy Forward Laboratory
Major Thomas Dreierf 996th Medical Laboratory VA
SUBJECT: Anthrax PA Assay (Smart Test)
U)
l@ The following message has been provided to HQ, USAMRDC and
other interested parties. Action being implemented.is to recall
all assays to your level. Unclear at present whether recalled
tests will be returned to CONUS or remain in AOR, but you should
secure whatever you need now, Preliminary results here indicate
that lot 103 compares well with lot 100 when examining samples
from aerosol exposed monkeys. All sera from monkeys with high
bacterem'@a were clearly positive on both lots, and no false
positive reactions were noted. Low intensity false positive
reactions on lot 103 seen on normal human sera disappeared when
increased wash solution volume was added, but WN patient remained
as a clear false positive reaction. Anticipate testing on
febrile patient sera starting 30 Jan 91; will keep you posted of
results. Text of formal message is as follows.
2@BACKGROUNI): The New Horizons "Smart Test" for Anthrax is an
assay designed to rapidly detect a protein antigen produced
following infection with Bacillus anthracis, the cause of
anthrax. This antigen is called 11 r@@ctive antigen", or PA,
which is thought to be produced in all anthrax cases, regardless
of the infecting strain. The Smart Test was only recently
developed and we are continuing to determine its sensitivity and
t perfecto it has proven useful
in rapidly detecting PA under experimental conditions.
The most likely clinical presentation of anthrax to be seen
in a biowarfare scenario is inhalation anthrax. This form of the
disease is very rare under normal conditions, and the New
Horizons anthrax test has never been evaluated on humans
suffering from inhalation anthrax. The test is being carefully
evaluated an specimens obtained from nonhuman primates
experimentally infected by the aerosol route with Bacillus
anthracis. The resulting infection in non-h=an primates is
thought to closely parallel that seen in humans. Untreated,
unvaccinated, non-human primates exposed by the aerosol routs
suffer a disease which leads to death in three to eight days.
Reactivity of the Smart Test on serum closely parallels
bacteremia, with the test yielding clear positive results only
when bacteremia reaches >10,000 colony forming units per ml of
-Re,p. L@, UNCLASSIFIED
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Document 4 f:/Week-36/BX003203/ANTHRAX PA ASSAY SMART TEST/tips on conducting the test:11259610130311
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003203
Unit = OTSG
Parent Organization = HSC
Folder Title = ANTHRAX PA ASSAY SMART TEST
Folder Seq # = 24
Subject = TIPS ON CONDUCTING THE TEST
Document Seq # = 1
Document Date =
Scan Date =
Queued for Declassification = 01-JAN-1980
Short Term Referral = 01-JAN-1980
Long Term Referral = 01-JAN-1980
Permanent Referral = 01-JAN-1980
Non-Health Related Document = 01-JAN-1980
Declassified = 25-NOV-1996