Biolog

Enigl enigl at aol.com
Tue Jan 13 18:54:51 EST 1998


In article <01bd203f$e9931180$c9179e83 at ROGERS.AFRRI.USUHS.MIL>, "Jim Rogers"
<rogersj at nmripo.nmri.nnmc.navy.mil> writes:

>I like Biolog because their database of strains is larger and
>supposedly
being added to frequently.>>

The problem is that the reproducibility is not there.  If you run the "same"
isolate ten times, you get ten different I.D.s--according the FDA validation
studies, that is why FDA did not approve BIOLOG (yet).

 They are adding an anaerobe database
>soon, and
is potentially field deployable.>>

Vitek has had an anaerobe clinical data base for years and there system flies
on the Space Shuttle--so, I guess that is the ultimate in "field deployable." 
the Vitek also has a system that was scheduled to go to Mars to search for life
and run biochemical tests on any isolates found--I saw the system--very "cool."

<<  They also seem to be the choice
>of a
number of researchers when analyzing mixed populations in
>different
environments.>>

Yes I've seen those reports.  The only thing that I find troubling is that the
reproducibility of BIOLOG is so poor, how can those reports generate usable
conclusion?

<<  And finally, it is reasonable to do stats on your
>strains
and to make up your own databases that are based on your
>own
results/strains.>>

Yes, that is also what the Vitek database does, even unknowns that were not in
the database--mostly water environmental isolates.

<<  The downside is that it is not approved by the
>various
agencies and their database on BL-3 level organisms is pretty small.
>It is
also a little expensive on a per test basis.>>

Vitek has the same downsides--very expensive.  Vitek has two data bases, one
for clinical and one for industrial--a wise move.

On the upside, BIOLOG _themselves_ have finally had a validation protocol
written by a microbiology consultant (not me, although I write them too) to try
and get the FDA to accept BIOLOG as a valid pharmaceutical test method--no word
on if it has been successful yet.

Davin
--------------------------------------------------------------------------
------------------------------
Davin C. Enigl,  Microbiology Consultant,
MEAS-Master of Environmental Arts and Sciences.

1.  Discovered heat resistance in mold: _Talaromyces trachyspermus_ (Published
w/USDA)

2.  Co-author (with Kent M. Sorrells), Water Activity and Self-Preserving
Formulas,
In:  _Preservative-Free and Self-Preserving Cosmetics and Drugs_, Kabara and
Orth, editors.  Copyright 1997,
Marcel-Dekker, ISBN 0-8247-9366-8, Telephone: 1-800-228-1160

3.  Water System Design and Validation for FDA regulations

4.  Preservative Formulation and Stability Testing

5.  FDA Validation Protocols: aseptic, sterilization, laboratory methods

6.  Hazard Analysis and Critical Control Points (HACCP)

7.  Current Good Manufacturing Practices (cGMP)  Audits

Web Site:  http://members.aol.com/enigl/

January 13, 1998
2:01 pm PACIFIC
Davin C. Enigl, MEAS. Microbiology Consultant for Foods, Cosmetics,
Pharmaceuticals and Biotechnology. FDA validation protocols, water system,
autoclave, facility start-up. Author: _Preservative-Free and Self-Preserving
Cosmetics and Drugs_ Marcel Dekker.



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