Quantification Came Up
On Yahoo MMTC board a Quantification question came up. On the Yahoo MMTC board one of the posted message was a email from a distributor from an other country. Here is the email
******
Dear Sir,
In [country] the MIT 1000 will do work if it prove the quantification ability for analysis .
Hope you will understand.
With Regards
*******
So I did some digging and posted this
I don't know what kind of guidlines other countries have but after reading through the spec sheet of the MIT 1000 which can be found on their web site I come to the following conclusion that the MIT 1000 can count the quantity of micros found in a sample. Below are some copy and paste from the the spec sheet:
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Identification Measurement
FIG 16 shows the identification probability accumulation graphically using actual data. In
this case, a colony of E. coli O157:H710 was sampled and measured. After the 15th event,
the probability for E. coli
O157:H7 rises above
99.9% and the sum of the
probabilities of all the other
species drops below 0.1%.
The identification occurs
when one curve is above
0.999 for five sequential
measurements. The identification
shown in FIG 16
occurred after measuring 20
cells in an elapsed measurement
time of about three
minutes.***
I don't know what the Distributor means by Quantification, but the ability to count indiviual cells of the species seems to mean quantificaton.
Here is another copy and paste from the spec sheet.
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Validation
North American Science Associates, Inc. (“NAMSA”) has validated the MIT Colony
Identification process. For over 35 years, NAMSA has been one of the world's leading
independent laboratories specializing in the safety evaluation of medical devices.
NAMSA offers testing services and products to device manufacturers, raw material suppliers,
pharmaceutical companies, sterilizers, and other related industries - primarily serving
the health care industry.
NAMSA evaluated biocompatibility appropriate to the intended use of MIT’s rapid microbe
detection and identification system compared with conventional microbe identification
systems. NAMSA’s programs follow Food and Drug Administration (FDA) guidance
and International Organization for Standardization (ISO) 10993 standards.
NAMSA chose the industry standard MIDI Sherlock Microbial Identification System
(“MIDI”) as the initial process to verify the accuracy of MIT’s diagnostic capabilities.
The MIDI system identifies bacteria and yeast based on gas chromatographic (GC) analysis
of fatty acid methyl esters (GC-FAME).
American Type Culture Collection (“ATCC”) provided the microbes. ATCC’s Bacteriology
Collection is the most diversified assemblage of prokaryotes in the world, containing
nearly 18,000 strains in more than 750 genera. Every important prokaryotic physiological
group is represented. The Collection holds more than 3,600 type cultures of validly described
species, forming the basis for systematic bacteriology, and nearly 500 bacteriophages.
ATCC provided five (5) certified bacteria samples for the comparative study between
the MIT and MIDI Systems.
Test results: NAMSA performed 50 tests on the MIT system, ten specimens for each of
the five bacterial species, and had 49 correct identifications (98 percent correct). Average
time for sample preparation was approximately one minute and the average test time was
about three minutes. NAMSA performed five tests on the MIDI system, one for each of
the five bacterial species, and had four correct identifications (80 percent correct). The
incorrectly identified sample was repetitively tested and was still not properly identified
by the MIDI System. Average time for sample preparation was approximately one hour
and the average test time was about 20 minutes.
A copy of the report is available upon request.
************
Now if NAMSA’s programs follow Food and Drug Administration (FDA) guidance
and International Organization for Standardization (ISO) 10993 standards,
won't you think that one of the findings would of been "NOT ABLE TO ESTABLISH QUANTIFICATION".
These are just my opion and would like to hear what other folks have to say.
Dogma
