TIPS ON CONDUCTING THE TEST

File: 120396_sep96_decls71_0003.txt
Page: 0003
Total Pages: 4

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 30 191 10:15 USAMPDC       ;  Lu@@,     -p@                     P.3
                                UNCLASSIFIED


         blood, Thus, for 48 to 72 hours following aerosol exposure non-
         human primates are clinically well, have undetectable levels of
         bacteremia, and are negative by the Smart Test. Beginning at day
         3 to 4 post exposure, non-human primates begin to show signs of
         clinical illness, bactere-,nia occurs, and the Smart Test may show
         weakly positive signals, AS the disease course progresses toward
         deathI bacteremia levels rapidly risep and the Smart Test becomes
         clearly positive. Post-mortem samples are likewise clearly
         positive in the Smart Test,
         3. FALSE POSITIVE REACTIONS: The New Horizons Smart Test is
         known to produce false positive reactions, These reactions
         generally fall into two categories; either as weak to moderate
         signals (+/- to +2)p or clearly positive reactions (+3/+4). In
         tests of sera drawn from healthy Marines, only weak to moderate
         false positive signals were seen, at a rate of from 7 to 15%.
         When sera from acute febrile patients were tested, weak to
         moderate intensity positive reactions were found in nearly 20t of
         sera tested, and clearly positive signals were found in 3 to 5%
         of sera. The weak to moderate false positive reactions appear to
         be associated with reduced volumes of wash buffer, due to
         variability of the size of drop dispensed from the wash solution
         bottles. Preliminary results suggest that tripling the volume of
         wash buffer added, from two drops to six drops, removes many of
         the weak to moderate intensity false positive reactions. This
         procedure does not, however, remove the strong false positive.
         reactions, thus a persistent rate of false positivity of at least
         5% remains.
f sera tested
         from acutely ill non-human primates following aerosol exposure to
         Bacillus anthracial whose bacteremia was low (<10,000 colony
         forming units per ml of whole blood), 10 of 18 gave negative
         reactions. Virtually all non-human primates however, went on to
         yield positive results as their disease progressed. A problem
         was notedr however, in the test itself. Roughly 10% of the tests
         done on normal human sera were read as negative, when in factf
         the liquid from the swab had apparently not passed through the
         filter, and the side of the assay where results are to be read
         was completely dry. Thus, a mechanical failure prevented an
         accurate reading. This was easily corrected when additional wash
         solution was placed on the swab, the swab replaced in the assay
         chamber, and pressure applied.
         5. CONCLUSION$: Considering the results of tests on material
         from non-human primate aerosol infections, and the rate of false
         positive reactions encountered, especially when too little wash
         solution was added, it is clear that the Smart Test SHOULD NOT be
         used as a general screening test for @L febrile patTe-nti.- MM
         TEST SHOULD BE LIMTTEN TO USE ON CLIMCALLY ILL PAT
                                                              'ENT2e .. u d
                  eA STRON                          it siiouia not
         immepd at ly after a suspected biowarfare attack has occurred.
         This test is likely to yield true positive reactions only on
         patients who are very seriously ill, with very high levels of

                                   UNCLASSIFIED
                                    9;el-4 14.

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